A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing
A Phase 3, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of RPC1063 Administered Orally To Relapsing Multiple Sclerosis Patients
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Ozanimod
Sphingosine 1-phosphate receptor 5 modulator
Results by group
Number of Participants Experiencing Adverse Events (AEs)
From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Parent Treatment Group IFN-B-1a 30 ug | 668 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 775 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 776 Participants | 881 |
Parent Treatment Group IFN-B-1a 30 ug
Parent Treatment Group: RPC1063 0.5 mg
Parent Treatment Group: RPC1063 1.0 mg
Number of Participants Experiencing Serious Adverse Events (SAEs)
From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Parent Treatment Group IFN-B-1a 30 ug | 108 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 139 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 134 Participants | 881 |
Parent Treatment Group IFN-B-1a 30 ug
Parent Treatment Group: RPC1063 0.5 mg
Parent Treatment Group: RPC1063 1.0 mg
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Parent Treatment Group IFN-B-1a 30 ug | 35 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 35 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 28 Participants | 881 |
Parent Treatment Group IFN-B-1a 30 ug
Parent Treatment Group: RPC1063 0.5 mg
Parent Treatment Group: RPC1063 1.0 mg
Number of Participants Experiencing Adverse Events (AEs) Leading to Withdrawal
From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Parent Treatment Group IFN-B-1a 30 ug | 32 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 35 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 28 Participants | 881 |
Parent Treatment Group IFN-B-1a 30 ug
Parent Treatment Group: RPC1063 0.5 mg
Parent Treatment Group: RPC1063 1.0 mg
Number of Participants Experiencing Adverse Events (AEs) of Special Interest
From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Parent Treatment Group IFN-B-1a 30 ug | 19 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 26 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 19 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 9 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 14 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 16 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 1 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 2 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 1 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 5 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 2 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 2 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 1 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 2 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 1 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 0 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 1 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 1 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 0 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 15 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 14 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 8 Participants | 881 |
Number of Participants With Abnormalities in Blood Absolute Lymphocyte Count (ALC)
From first dose up until last dose of study treatment (up to approximately 82 months)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Parent Treatment Group IFN-B-1a 30 ug | 33 Participants | 727 | |
| Parent Treatment Group: RPC1063 0.5 mg | 33 Participants | 868 | |
| Parent Treatment Group: RPC1063 1.0 mg | 27 Participants | 877 | |
| Parent Treatment Group IFN-B-1a 30 ug | 265 Participants | 727 | |
| Parent Treatment Group: RPC1063 0.5 mg | 323 Participants | 868 | |
| Parent Treatment Group: RPC1063 1.0 mg | 339 Participants | 877 | |
| Parent Treatment Group IFN-B-1a 30 ug | 497 Participants | 727 | |
| Parent Treatment Group: RPC1063 0.5 mg | 620 Participants | 868 | |
| Parent Treatment Group: RPC1063 1.0 mg | 616 Participants | 877 | |
| Parent Treatment Group IFN-B-1a 30 ug | 592 Participants | 727 | |
| Parent Treatment Group: RPC1063 0.5 mg | 703 Participants | 868 | |
| Parent Treatment Group: RPC1063 1.0 mg | 704 Participants | 877 |
Number of Participants With Abnormalities in White Blood Cell Count (WBC)
From first dose up until last dose of study treatment (up to approximately 82 months)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 727 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 868 | |
| Parent Treatment Group: RPC1063 1.0 mg | 2 Participants | 877 | |
| Parent Treatment Group IFN-B-1a 30 ug | 27 Participants | 727 | |
| Parent Treatment Group: RPC1063 0.5 mg | 48 Participants | 868 | |
| Parent Treatment Group: RPC1063 1.0 mg | 43 Participants | 877 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 727 | |
| Parent Treatment Group: RPC1063 0.5 mg | 2 Participants | 868 | |
| Parent Treatment Group: RPC1063 1.0 mg | 0 Participants | 877 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 727 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 868 | |
| Parent Treatment Group: RPC1063 1.0 mg | 0 Participants | 877 | |
| Parent Treatment Group IFN-B-1a 30 ug | 92 Participants | 727 | |
| Parent Treatment Group: RPC1063 0.5 mg | 107 Participants | 868 | |
| Parent Treatment Group: RPC1063 1.0 mg | 108 Participants | 877 |
Number of Participants With Abnormalities in Blood Absolute Neutrophil Count (ANC)
From first dose up until last dose of study treatment (up to approximately 82 months)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 727 | |
| Parent Treatment Group: RPC1063 0.5 mg | 2 Participants | 868 | |
| Parent Treatment Group: RPC1063 1.0 mg | 1 Participants | 877 |
Parent Treatment Group IFN-B-1a 30 ug
Parent Treatment Group: RPC1063 0.5 mg
Parent Treatment Group: RPC1063 1.0 mg
Number of Participants With Abnormalities in Specific Liver Function Tests
From first dose up until last dose of study treatment (up to approximately 82 months)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Parent Treatment Group IFN-B-1a 30 ug | 311 Participants | 734 | |
| Parent Treatment Group: RPC1063 0.5 mg | 353 Participants | 875 | |
| Parent Treatment Group: RPC1063 1.0 mg | 353 Participants | 880 | |
| Parent Treatment Group IFN-B-1a 30 ug | 90 Participants | 734 | |
| Parent Treatment Group: RPC1063 0.5 mg | 100 Participants | 875 | |
| Parent Treatment Group: RPC1063 1.0 mg | 107 Participants | 880 | |
| Parent Treatment Group IFN-B-1a 30 ug | 32 Participants | 734 | |
| Parent Treatment Group: RPC1063 0.5 mg | 30 Participants | 875 | |
| Parent Treatment Group: RPC1063 1.0 mg | 29 Participants | 880 | |
| Parent Treatment Group IFN-B-1a 30 ug | 16 Participants | 734 | |
| Parent Treatment Group: RPC1063 0.5 mg | 19 Participants | 875 | |
| Parent Treatment Group: RPC1063 1.0 mg | 6 Participants | 880 | |
| Parent Treatment Group IFN-B-1a 30 ug | 8 Participants | 734 | |
| Parent Treatment Group: RPC1063 0.5 mg | 12 Participants | 875 | |
| Parent Treatment Group: RPC1063 1.0 mg | 0 Participants | 880 | |
| Parent Treatment Group IFN-B-1a 30 ug | 4 Participants | 734 | |
| Parent Treatment Group: RPC1063 0.5 mg | 5 Participants | 875 | |
| Parent Treatment Group: RPC1063 1.0 mg | 0 Participants | 880 |
Number of Participants With Electrocardiogram (ECG) Result Abnormalities
From first dose to 28-days post last dose (an average of 63 months up to a max of 83 months)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Parent Treatment Group IFN-B-1a 30 ug | 6 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 5 Participants | 876 | |
| Parent Treatment Group: RPC1063 1.0 mg | 3 Participants | 880 | |
| Parent Treatment Group IFN-B-1a 30 ug | 1 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 876 | |
| Parent Treatment Group: RPC1063 1.0 mg | 0 Participants | 880 | |
| Parent Treatment Group IFN-B-1a 30 ug | 44 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 49 Participants | 876 | |
| Parent Treatment Group: RPC1063 1.0 mg | 44 Participants | 880 | |
| Parent Treatment Group IFN-B-1a 30 ug | 1 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 5 Participants | 876 | |
| Parent Treatment Group: RPC1063 1.0 mg | 3 Participants | 880 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 876 | |
| Parent Treatment Group: RPC1063 1.0 mg | 0 Participants | 880 | |
| Parent Treatment Group IFN-B-1a 30 ug | 173 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 186 Participants | 876 | |
| Parent Treatment Group: RPC1063 1.0 mg | 184 Participants | 880 | |
| Parent Treatment Group IFN-B-1a 30 ug | 8 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 15 Participants | 876 | |
| Parent Treatment Group: RPC1063 1.0 mg | 13 Participants | 880 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 2 Participants | 876 | |
| Parent Treatment Group: RPC1063 1.0 mg | 0 Participants | 880 | |
| Parent Treatment Group IFN-B-1a 30 ug | 134 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 140 Participants | 876 | |
| Parent Treatment Group: RPC1063 1.0 mg | 120 Participants | 880 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 5 Participants | 876 | |
| Parent Treatment Group: RPC1063 1.0 mg | 6 Participants | 880 | |
| Parent Treatment Group IFN-B-1a 30 ug | 183 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 215 Participants | 876 | |
| Parent Treatment Group: RPC1063 1.0 mg | 205 Participants | 880 | |
| Parent Treatment Group IFN-B-1a 30 ug | 5 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 9 Participants | 876 | |
| Parent Treatment Group: RPC1063 1.0 mg | 13 Participants | 880 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 876 | |
| Parent Treatment Group: RPC1063 1.0 mg | 1 Participants | 880 |
Number of Participants With Clinically Relevant Abnormalities in Vital Signs
At baseline and 60 months after first dose of study therapy
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 567 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 715 | |
| Parent Treatment Group: RPC1063 1.0 mg | 0 Participants | 707 | |
| Parent Treatment Group IFN-B-1a 30 ug | 15 Participants | 567 | |
| Parent Treatment Group: RPC1063 0.5 mg | 19 Participants | 715 | |
| Parent Treatment Group: RPC1063 1.0 mg | 26 Participants | 707 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 567 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 715 | |
| Parent Treatment Group: RPC1063 1.0 mg | 0 Participants | 707 | |
| Parent Treatment Group IFN-B-1a 30 ug | 15 Participants | 567 | |
| Parent Treatment Group: RPC1063 0.5 mg | 19 Participants | 715 | |
| Parent Treatment Group: RPC1063 1.0 mg | 26 Participants | 707 | |
| Parent Treatment Group IFN-B-1a 30 ug | 7 Participants | 567 | |
| Parent Treatment Group: RPC1063 0.5 mg | 12 Participants | 715 | |
| Parent Treatment Group: RPC1063 1.0 mg | 8 Participants | 707 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 567 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 715 | |
| Parent Treatment Group: RPC1063 1.0 mg | 0 Participants | 707 | |
| Parent Treatment Group IFN-B-1a 30 ug | 7 Participants | 567 | |
| Parent Treatment Group: RPC1063 0.5 mg | 12 Participants | 715 | |
| Parent Treatment Group: RPC1063 1.0 mg | 8 Participants | 707 | |
| Parent Treatment Group IFN-B-1a 30 ug | 3 Participants | 567 | |
| Parent Treatment Group: RPC1063 0.5 mg | 5 Participants | 715 | |
| Parent Treatment Group: RPC1063 1.0 mg | 5 Participants | 707 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 567 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 715 | |
| Parent Treatment Group: RPC1063 1.0 mg | 0 Participants | 707 | |
| Parent Treatment Group IFN-B-1a 30 ug | 3 Participants | 567 | |
| Parent Treatment Group: RPC1063 0.5 mg | 5 Participants | 715 | |
| Parent Treatment Group: RPC1063 1.0 mg | 5 Participants | 707 | |
| Parent Treatment Group IFN-B-1a 30 ug | 3 Participants | 567 | |
| Parent Treatment Group: RPC1063 0.5 mg | 1 Participants | 715 | |
| Parent Treatment Group: RPC1063 1.0 mg | 3 Participants | 707 | |
| Parent Treatment Group IFN-B-1a 30 ug | 1 Participants | 567 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 715 | |
| Parent Treatment Group: RPC1063 1.0 mg | 0 Participants | 707 | |
| Parent Treatment Group IFN-B-1a 30 ug | 2 Participants | 567 | |
| Parent Treatment Group: RPC1063 0.5 mg | 1 Participants | 715 | |
| Parent Treatment Group: RPC1063 1.0 mg | 3 Participants | 707 | |
| Parent Treatment Group IFN-B-1a 30 ug | 2 Participants | 567 | |
| Parent Treatment Group: RPC1063 0.5 mg | 4 Participants | 715 | |
| Parent Treatment Group: RPC1063 1.0 mg | 4 Participants | 707 | |
| Parent Treatment Group IFN-B-1a 30 ug | 1 Participants | 567 | |
| Parent Treatment Group: RPC1063 0.5 mg | 2 Participants | 715 | |
| Parent Treatment Group: RPC1063 1.0 mg | 3 Participants | 707 | |
| Parent Treatment Group IFN-B-1a 30 ug | 1 Participants | 567 | |
| Parent Treatment Group: RPC1063 0.5 mg | 2 Participants | 715 | |
| Parent Treatment Group: RPC1063 1.0 mg | 2 Participants | 707 | |
| Parent Treatment Group IFN-B-1a 30 ug | 1 Participants | 567 | |
| Parent Treatment Group: RPC1063 0.5 mg | 2 Participants | 715 | |
| Parent Treatment Group: RPC1063 1.0 mg | 0 Participants | 707 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 567 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 715 | |
| Parent Treatment Group: RPC1063 1.0 mg | 0 Participants | 707 | |
| Parent Treatment Group IFN-B-1a 30 ug | 1 Participants | 567 | |
| Parent Treatment Group: RPC1063 0.5 mg | 2 Participants | 715 | |
| Parent Treatment Group: RPC1063 1.0 mg | 0 Participants | 707 |
Number of Participants With Physical Examination Abnormalities
At baseline and every 12 months thereafter up until 84 months post first dose.
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 1 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 3 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 2 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 8 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 1 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 1 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 1 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 1 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 1 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 2 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 1 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 3 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 1 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 1 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 5 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 2 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 6 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 4 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 17 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 17 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 16 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 1 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 2 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 2 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 2 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 4 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 6 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 2 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 2 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 3 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 3 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 0 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 1 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 1 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 3 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 1 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 3 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 0 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 2 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 4 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 2 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 25 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 24 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 21 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 2 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 2 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 5 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 9 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 6 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 3 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 4 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 2 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 1 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 3 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 1 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 1 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 2 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 2 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 1 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 3 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 2 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 3 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 3 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 20 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 21 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 23 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 1 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 1 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 1 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 5 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 5 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 7 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 1 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 4 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 1 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 1 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 2 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 1 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 1 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 1 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 0 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 1 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 1 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 4 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 4 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 4 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 4 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 22 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 32 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 34 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 1 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 4 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 7 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 5 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 1 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 2 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 1 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 1 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 1 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 2 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 1 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 0 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 3 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 1 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 0 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 2 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 3 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 4 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 19 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 23 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 18 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 1 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 2 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 0 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 4 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 9 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 11 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 1 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 1 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 1 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 2 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 1 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 2 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 2 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 0 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 2 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 1 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 4 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 3 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 4 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 1 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 16 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 28 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 18 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 1 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 2 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 2 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 4 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 5 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 5 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 1 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 1 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 0 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 1 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 1 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 0 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 2 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 2 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 2 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 5 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 3 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 2 Participants | 881 | |
| Parent Treatment Group IFN-B-1a 30 ug | 8 Participants | 736 | |
| Parent Treatment Group: RPC1063 0.5 mg | 19 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 10 Participants | 881 | |
| Parent Treatment Group: RPC1063 0.5 mg | 1 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 0 Participants | 881 | |
| Parent Treatment Group: RPC1063 0.5 mg | 1 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 1 Participants | 881 | |
| Parent Treatment Group: RPC1063 0.5 mg | 2 Participants | 877 | |
| Parent Treatment Group: RPC1063 1.0 mg | 0 Participants | 881 |
Number of Participants Self-Identifying Suicidality by Columbia-Suicide Severity Rating Scale (C-SSRS)
At baseline and every 3 months thereafter up until 78 months post first dose.
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 733 | |
| Parent Treatment Group: RPC1063 0.5 mg | 2 Participants | 874 | |
| Parent Treatment Group: RPC1063 1.0 mg | 0 Participants | 879 | |
| Parent Treatment Group IFN-B-1a 30 ug | 2 Participants | 733 | |
| Parent Treatment Group: RPC1063 0.5 mg | 1 Participants | 874 | |
| Parent Treatment Group: RPC1063 1.0 mg | 1 Participants | 879 | |
| Parent Treatment Group IFN-B-1a 30 ug | 1 Participants | 733 | |
| Parent Treatment Group: RPC1063 0.5 mg | 1 Participants | 874 | |
| Parent Treatment Group: RPC1063 1.0 mg | 2 Participants | 879 | |
| Parent Treatment Group IFN-B-1a 30 ug | 3 Participants | 733 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 874 | |
| Parent Treatment Group: RPC1063 1.0 mg | 1 Participants | 879 | |
| Parent Treatment Group IFN-B-1a 30 ug | 3 Participants | 733 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 874 | |
| Parent Treatment Group: RPC1063 1.0 mg | 2 Participants | 879 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 733 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 874 | |
| Parent Treatment Group: RPC1063 1.0 mg | 1 Participants | 879 | |
| Parent Treatment Group IFN-B-1a 30 ug | 1 Participants | 733 | |
| Parent Treatment Group: RPC1063 0.5 mg | 1 Participants | 874 | |
| Parent Treatment Group: RPC1063 1.0 mg | 2 Participants | 879 | |
| Parent Treatment Group IFN-B-1a 30 ug | 1 Participants | 733 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 874 | |
| Parent Treatment Group: RPC1063 1.0 mg | 1 Participants | 879 | |
| Parent Treatment Group IFN-B-1a 30 ug | 1 Participants | 733 | |
| Parent Treatment Group: RPC1063 0.5 mg | 2 Participants | 874 | |
| Parent Treatment Group: RPC1063 1.0 mg | 1 Participants | 879 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 733 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 874 | |
| Parent Treatment Group: RPC1063 1.0 mg | 0 Participants | 879 | |
| Parent Treatment Group IFN-B-1a 30 ug | 1 Participants | 733 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 874 | |
| Parent Treatment Group: RPC1063 1.0 mg | 0 Participants | 879 | |
| Parent Treatment Group IFN-B-1a 30 ug | 2 Participants | 733 | |
| Parent Treatment Group: RPC1063 0.5 mg | 1 Participants | 874 | |
| Parent Treatment Group: RPC1063 1.0 mg | 0 Participants | 879 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 733 | |
| Parent Treatment Group: RPC1063 0.5 mg | 1 Participants | 874 | |
| Parent Treatment Group: RPC1063 1.0 mg | 0 Participants | 879 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 733 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 874 | |
| Parent Treatment Group: RPC1063 1.0 mg | 1 Participants | 879 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 733 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 874 | |
| Parent Treatment Group: RPC1063 1.0 mg | 0 Participants | 879 | |
| Parent Treatment Group IFN-B-1a 30 ug | 2 Participants | 733 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 874 | |
| Parent Treatment Group: RPC1063 1.0 mg | 1 Participants | 879 | |
| Parent Treatment Group IFN-B-1a 30 ug | 1 Participants | 733 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 874 | |
| Parent Treatment Group: RPC1063 1.0 mg | 1 Participants | 879 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 733 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 874 | |
| Parent Treatment Group: RPC1063 1.0 mg | 0 Participants | 879 | |
| Parent Treatment Group IFN-B-1a 30 ug | 2 Participants | 733 | |
| Parent Treatment Group: RPC1063 0.5 mg | 1 Participants | 874 | |
| Parent Treatment Group: RPC1063 1.0 mg | 1 Participants | 879 | |
| Parent Treatment Group IFN-B-1a 30 ug | 1 Participants | 733 | |
| Parent Treatment Group: RPC1063 0.5 mg | 2 Participants | 874 | |
| Parent Treatment Group: RPC1063 1.0 mg | 1 Participants | 879 | |
| Parent Treatment Group IFN-B-1a 30 ug | 1 Participants | 733 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 874 | |
| Parent Treatment Group: RPC1063 1.0 mg | 1 Participants | 879 | |
| Parent Treatment Group IFN-B-1a 30 ug | 1 Participants | 733 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 874 | |
| Parent Treatment Group: RPC1063 1.0 mg | 1 Participants | 879 | |
| Parent Treatment Group IFN-B-1a 30 ug | 0 Participants | 733 | |
| Parent Treatment Group: RPC1063 0.5 mg | 0 Participants | 874 | |
| Parent Treatment Group: RPC1063 1.0 mg | 1 Participants | 879 |
Number of Participants With Changes in Suicidality From Last Day on Treatment Per the Columbia-Suicide Severity Rating Scale (C-SSRS)
1, 4, 7, 14, 21, 28, and 90 days post last dose.
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Combined Parent Treatment Group | 3 Participants | 250 | |
| Combined Parent Treatment Group | 0 Participants | 250 | |
| Combined Parent Treatment Group | 0 Participants | 250 | |
| Combined Parent Treatment Group | 0 Participants | 250 | |
| Combined Parent Treatment Group | 0 Participants | 250 | |
| Combined Parent Treatment Group | 0 Participants | 250 | |
| Combined Parent Treatment Group | 0 Participants | 250 | |
| Combined Parent Treatment Group | 0 Participants | 250 |
Change in Physician's Withdrawal Checklist (PWC-20) Total Score From Last Day on Treatment
1, 4, 7, 14, 21, and 90 days post last dose.
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Combined Parent Treatment Group | -0.1 Change in Score on a Scale | 6.33 (Standard Deviation) | 95 |
| Combined Parent Treatment Group | -0.6 Change in Score on a Scale | 5.06 (Standard Deviation) | 95 |
| Combined Parent Treatment Group | -0.5 Change in Score on a Scale | 4.51 (Standard Deviation) | 95 |
| Combined Parent Treatment Group | -1.1 Change in Score on a Scale | 4.33 (Standard Deviation) | 95 |
| Combined Parent Treatment Group | -0.4 Change in Score on a Scale | 4.93 (Standard Deviation) | 95 |
| Combined Parent Treatment Group | -1.2 Change in Score on a Scale | 5.31 (Standard Deviation) | 95 |
| Combined Parent Treatment Group | -0.7 Change in Score on a Scale | 5.15 (Standard Deviation) | 95 |
Change in Hospital Anxiety and Depression Scale (HADS) Score From Last Day on Treatment
1, 4, 7, 14, 21, and 90 days post last dose.
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Combined Parent Treatment Group | 0.3 Change in Score on a Scale | 3.17 (Standard Deviation) | 96 |
| Combined Parent Treatment Group | -0.1 Change in Score on a Scale | 2.15 (Standard Deviation) | 96 |
| Combined Parent Treatment Group | -0.1 Change in Score on a Scale | 2.13 (Standard Deviation) | 96 |
| Combined Parent Treatment Group | -0.2 Change in Score on a Scale | 2.29 (Standard Deviation) | 96 |
| Combined Parent Treatment Group | 0.1 Change in Score on a Scale | 2.36 (Standard Deviation) | 96 |
| Combined Parent Treatment Group | 0.1 Change in Score on a Scale | 2.35 (Standard Deviation) | 96 |
| Combined Parent Treatment Group | -0.2 Change in Score on a Scale | 2.86 (Standard Deviation) | 96 |
| Combined Parent Treatment Group | -0.3 Change in Score on a Scale | 2.76 (Standard Deviation) | 96 |
| Combined Parent Treatment Group | -0.5 Change in Score on a Scale | 2.33 (Standard Deviation) | 96 |
| Combined Parent Treatment Group | -0.4 Change in Score on a Scale | 2.3 (Standard Deviation) | 96 |
| Combined Parent Treatment Group | -0.8 Change in Score on a Scale | 2.47 (Standard Deviation) | 96 |
| Combined Parent Treatment Group | -0.6 Change in Score on a Scale | 2.17 (Standard Deviation) | 96 |
| Combined Parent Treatment Group | -0.7 Change in Score on a Scale | 2.35 (Standard Deviation) | 96 |
| Combined Parent Treatment Group | -0.7 Change in Score on a Scale | 2.99 (Standard Deviation) | 96 |
Changes in Epworth Sleepiness Scale (ESS) Score From Last Day on Treatment
1, 4, 7, 14, 21, and 90 days post last dose.
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Combined Parent Treatment Group | 0.4 Change in Score on a Scale | 4.92 (Standard Deviation) | 96 |
| Combined Parent Treatment Group | -0.6 Change in Score on a Scale | 4.28 (Standard Deviation) | 96 |
| Combined Parent Treatment Group | -0.5 Change in Score on a Scale | 4.38 (Standard Deviation) | 96 |
| Combined Parent Treatment Group | -0.7 Change in Score on a Scale | 4.25 (Standard Deviation) | 96 |
| Combined Parent Treatment Group | -0.9 Change in Score on a Scale | 4.1 (Standard Deviation) | 96 |
| Combined Parent Treatment Group | -0.9 Change in Score on a Scale | 4.42 (Standard Deviation) | 96 |
| Combined Parent Treatment Group | -0.8 Change in Score on a Scale | 3.75 (Standard Deviation) | 96 |
Changes in Vital Sign Values From Last Day on Treatment
1, 4, 7, 14, 21, 28, and 90 days post last dose.
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Combined Parent Treatment Group | -1.77 mmHg | 11.189 (Standard Deviation) | 252 |
| Combined Parent Treatment Group | 0.63 mmHg | 8.311 (Standard Deviation) | 252 |
| Combined Parent Treatment Group | -0.04 mmHg | 8.931 (Standard Deviation) | 252 |
| Combined Parent Treatment Group | 0.82 mmHg | 7.911 (Standard Deviation) | 252 |
| Combined Parent Treatment Group | -0.4 mmHg | 8.128 (Standard Deviation) | 252 |
| Combined Parent Treatment Group | 1.25 mmHg | 9.029 (Standard Deviation) | 252 |
| Combined Parent Treatment Group | -0.72 mmHg | 11.135 (Standard Deviation) | 252 |
| Combined Parent Treatment Group | -0.69 mmHg | 10.865 (Standard Deviation) | 252 |
| Combined Parent Treatment Group | -1.10 mmHg | 8.356 (Standard Deviation) | 252 |
| Combined Parent Treatment Group | -1.18 mmHg | 8.218 (Standard Deviation) | 252 |
| Combined Parent Treatment Group | -2.02 mmHg | 7.76 (Standard Deviation) | 252 |
| Combined Parent Treatment Group | -1.80 mmHg | 7.275 (Standard Deviation) | 252 |
| Combined Parent Treatment Group | -1.82 mmHg | 7.643 (Standard Deviation) | 252 |
| Combined Parent Treatment Group | -1.00 mmHg | 8.181 (Standard Deviation) | 252 |
| Combined Parent Treatment Group | -1.21 mmHg | 8.103 (Standard Deviation) | 252 |
| Combined Parent Treatment Group | -2.01 mmHg | 7.689 (Standard Deviation) | 252 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Parent Treatment Group: Placebo for RPC1063 0.5 mg | 37 | 7 (18.9%) | 0 |
| Parent Treatment Group: Placebo for RPC1063 1 mg | 35 | 3 (8.6%) | 0 |
| Parent Treatment Group IFN-B-1a 30 ug | 736 | 108 (14.7%) | 6 |
| Parent Treatment Group: RPC1063 0.5 mg | 840 | 132 (15.7%) | 5 |
| Parent Treatment Group: RPC1063 1.0 mg | 846 | 131 (15.5%) | 5 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Number of Participants Experiencing Adverse Events (AEs)
From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months)
SafetyNumber of Participants Experiencing Serious Adverse Events (SAEs)
From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months)
SafetyNumber of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months)
SafetyNumber of Participants Experiencing Adverse Events (AEs) Leading to Withdrawal
From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months)
SafetyNumber of Participants Experiencing Adverse Events (AEs) of Special Interest
From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months)
SafetyNumber of Participants With Abnormalities in Blood Absolute Lymphocyte Count (ALC)
From first dose up until last dose of study treatment (up to approximately 82 months)
Immune responseNumber of Participants With Abnormalities in White Blood Cell Count (WBC)
From first dose up until last dose of study treatment (up to approximately 82 months)
Number of Participants With Abnormalities in Blood Absolute Neutrophil Count (ANC)
From first dose up until last dose of study treatment (up to approximately 82 months)
Number of Participants With Abnormalities in Specific Liver Function Tests
From first dose up until last dose of study treatment (up to approximately 82 months)
SafetyNumber of Participants With Electrocardiogram (ECG) Result Abnormalities
From first dose to 28-days post last dose (an average of 63 months up to a max of 83 months)
Number of Participants With Clinically Relevant Abnormalities in Vital Signs
At baseline and 60 months after first dose of study therapy
SafetyNumber of Participants With Physical Examination Abnormalities
At baseline and every 12 months thereafter up until 84 months post first dose.
Number of Participants Self-Identifying Suicidality by Columbia-Suicide Severity Rating Scale (C-SSRS)
At baseline and every 3 months thereafter up until 78 months post first dose.
Number of Participants With Changes in Suicidality From Last Day on Treatment Per the Columbia-Suicide Severity Rating Scale (C-SSRS)
1, 4, 7, 14, 21, 28, and 90 days post last dose.
Change in Physician's Withdrawal Checklist (PWC-20) Total Score From Last Day on Treatment
1, 4, 7, 14, 21, and 90 days post last dose.
Change in Hospital Anxiety and Depression Scale (HADS) Score From Last Day on Treatment
1, 4, 7, 14, 21, and 90 days post last dose.
Mood and sleepQuality of life (reported by participants)Changes in Epworth Sleepiness Scale (ESS) Score From Last Day on Treatment
1, 4, 7, 14, 21, and 90 days post last dose.
Mood and sleepChanges in Vital Sign Values From Last Day on Treatment
1, 4, 7, 14, 21, 28, and 90 days post last dose.
SafetySafety Endpoints
Safety
Other measures (16)
Annualized Relapse Rate (ARR)
From first dose up until last dose of study treatment or data-cutoff date, whichever occurred first (up to approximately 87 months)
RelapsesMRI lesionsTime to First Relapse (TFR)
Overall: From first dose to first relapse, last dose, or data-cutoff date, whichever occurred first (up to approx 87 months); Visits: 2 weeks post first dose, 3 months post first dose, and every 3 mon
RelapsesNumber of Participants Who Were Relapse Free
From first dose to last dose of study treatment or data-cutoff date, whichever occurred first (up to approximately 87 months)
RelapsesAverage Number of New or Enlarging Hyperintense T2-Weighted Brain MRI Lesions Per Scan at Each Visit
At 12 months post first dose and every 12 months thereafter up until 72 months post first dose.
MRI lesionsAverage Number of Gadolinium-Enhanced (GdE) Brain MRI Lesions Per Scan at Each Visit
At baseline and every 12 months thereafter up until 72 months post first dose.
MRI lesionsTime to Onset of Disability Progression as Defined by a Sustained Worsening in Expanded Disability Status Scale (EDSS)
At 3 and 6 months post first dose.
Disability progressionBladder, bowel and sexual functionNumber of Participants Free of Gadolinium-Enhanced (GdE) Brain Lesions at Each Visit
At baseline and every 12 months thereafter up until 72 months post first dose.
MRI lesionsNumber of Participants Free of New or Enlarging T2 Lesions at Each Visit
At baseline and every 12 months thereafter up until 72 months post first dose.
MRI lesionsPercent Change in Normalized Brain Volume (Atrophy) on Brain MRI Scans From Baseline at Each Visit
At baseline and every 12 months thereafter up until approximately 87 months post first dose.
MRI lesionsBrain volume lossThinking and memoryChange in Multiple Sclerosis Functional Composite (MSFC) Score From Baseline at Each Applicable Visit
At baseline and every 12 months thereafter up until 84 months post first dose.
Disability progressionVisionThinking and memoryWalking and mobilityArm and hand function
Who could take part
Relapsing MS · 18 to 55
Show the full criteria
Inclusion criteria
Eligibility Criteria: To be eligible to participate in this trial, patients must meet all of the following criteria: 1. Completed one of the parent trials 2. Does not have a condition that would require withdrawal from one of the parent trials 3. Has no conditions requiring treatment with a prohibited concomitant medication 4. Is not receiving treatment with any of the following drugs or interventions within the corresponding timeframe: At Baseline (Day 1) * CYP2C8 inhibitors (eg, gemfibrozil or clopidogrel) or inducers (eg, rifampicin) Two weeks prior to Baseline (Day 1) * Monoamine oxidase inhibitors (eg, selegiline, phenelzine) 5. Ability to provide written informed consent and to be compliant with the schedule of protocol assessments 6. Female patients of childbearing potential: Must agree to practice a highly effective method of contraception throughout the study until completion of the 90-day Safety Follow-up Visit. Highly effective methods of contraception are those that alone or in combination result in a failure rate of a Pearl index of less than 1% per year when used consistently and correctly. Acceptable methods of birth control in this study are the following: * Combined hormonal (estrogen and progestogen containing) contraception, which may be oral, intravaginal, or transdermal * Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injectable, or implantable * Placement of an intrauterine device (IUD) * Placement of an intrauterine hormone-releasing system (IUS) * Bilateral tubal occlusion * Vasectomised partner * Sexual abstinence. Exclusion Criteria:
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients with relapsing multiple sclerosis.
Papers
Results
Multiple Sclerosis Relapse Activity After Ozanimod Discontinuation in DAYBREAK Trial Participants.Ann Clin Transl Neurol · 2026
Results
Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis: Final analysis of the DAYBREAK open-label extension trial.Mult Scler · 2025
Results
Brain atrophy and associations with long-term disability and cognitive function in participants with relapsing multiple sclerosis treated with ozanimod: Results from phase 3 and open-label extension trials.Mult Scler · 2025
Results
Concomitant Administration of Ozanimod and Serotonergic Antidepressants in Patients With Ulcerative Colitis or Relapsing Multiple Sclerosis.Inflamm Bowel Dis · 2025
Results
Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis: Up to 5 years of follow-up in the DAYBREAK open-label extension trial.Mult Scler · 2022
Results
Effect of the sphingosine-1-phosphate receptor modulator ozanimod on leukocyte subtypes in relapsing MS.Neurol Neuroimmunol Neuroinflamm · 2020
Results
Rubin DT, Danese S, Nakase H, Ungaro RC, Wolf DC, Alekseeva O, Petersen A, Liu Z, Mehra D, Jain A, Osterman MT, Krakovich A, Riolo JV, DeBoer E, Appio J, Sinh P, Cree BAC, Cohen JA, Irving P. Integrated long-term safety of 10-year ozanimod treatment: results from clinical trials in patients with moderate-to-severe ulcerative colitis or relapsing multiple sclerosis. Inflamm Bowel Dis. 2026 May 1;32Results
Naismith RT, Cohen JA, Bar-Or A, Comi G, Selmaj KW, Hartung HP, Sheffield JK, Krakovich A, Tatosian D, Cheng CY, Reardon J, Khaychuk V, Riolo JV, Silva D, Cree BA. Concurrent administration of serotonergic antidepressants and ozanimod in participants with relapsing multiple sclerosis from the open-label extension DAYBREAK trial. Mult Scler. 2024 Feb;30(2):177-183. doi: 10.1177/13524585231216854. EResults
Cree BAC, Maddux R, Bar-Or A, Hartung HP, Kaur A, Brown E, Li Y, Hu Y, Sheffield JK, Silva D, Harris S. SARS-CoV-2 vaccination and infection in ozanimod-treated participants with relapsing multiple sclerosis. Ann Clin Transl Neurol. 2023 Oct;10(10):1725-1737. doi: 10.1002/acn3.51862. Epub 2023 Aug 7.
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History
Started
Oct 2015
Main results due
Jan 2023
Finished
Jan 2023
Results posted
Jan 2024