BG00012 Phase 2 Combination Study in Participants With Multiple Sclero
An Open-Label, Multicenter Study in Subjects With Relapsing-Remitting Multiple Sclerosis to Evaluate the Safety of 240 mg BG00012 TID Administered as Add-On Therapy to Beta Interferons (IFNβ) or Glatiramer Acetate (GA)
What it found
Results posted, not judged
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Dimethyl fumarate
Kelch-like ECH-associated protein 1 inhibitor
Results by group
Summary of Treatment-emergent Adverse Events (TEAEs) Occurring Post-BG00012 Dosing (Add-on Therapy Period)
AEs were collected from enrollment until the final study visit (Week 26 +/-5 days).
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 95 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 100 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 72 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 70 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 14 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 15 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 74 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 87 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 4 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 2 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 14 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 17 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 14 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 17 percentage of participants | 47 |
Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy
collected from the start of BG00012 administration through to Week 26 +/- 5 days
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 9 percentage of participants | 56 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 2 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 2 percentage of participants | 56 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 2 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 32 percentage of participants | 56 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 6 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 7 percentage of participants | 56 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 4 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 56 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 56 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 13 percentage of participants | 56 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 2 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 2 percentage of participants | 56 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 4 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 56 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 56 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 56 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 56 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 56 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 47 |
Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy
collected from the start of BG00012 administration through to Week 26 +/- 5 days
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 47 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 47 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 53 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 53 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 5 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 2 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 2 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 68 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 64 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 32 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 36 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 2 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 72 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 85 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 28 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 15 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 4 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 2 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 98 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 94 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 2 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 6 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 4 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 2 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 47 |
Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy
collected from the start of BG00012 administration through to Week 26 +/- 5 days
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 75 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 64 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 7 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 9 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 5 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 15 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 7 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 11 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 5 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 2 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 39 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 38 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 35 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 45 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 26 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 15 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 2 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 93 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 94 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 2 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 2 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 2 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 4 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 2 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 2 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 47 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 57 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 9 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 11 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 26 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 28 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 11 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 4 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 4 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 4 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 100 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 75 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 6 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 13 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 6 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 76 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 86 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 8 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 4 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 4 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 0 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 7 percentage of participants | 47 | |
| Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate) | 12 percentage of participants | 57 | |
| Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate) | 4 percentage of participants | 47 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Monotherapy Period: IFNß | 59 | 0 (0.0%) | |
| Monotherapy Period: GA | 49 | 0 (0.0%) | |
| Add-on Therapy Period: IFNß and BG00012 | 57 | 2 (3.5%) | |
| Add-on Therapy Period: GA and BG00012 | 47 | 1 (2.1%) |
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
Summary of Treatment-emergent Adverse Events (TEAEs) Occurring Post-BG00012 Dosing (Add-on Therapy Period)
AEs were collected from enrollment until the final study visit (Week 26 +/-5 days).
SafetyPotentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy
collected from the start of BG00012 administration through to Week 26 +/- 5 days
SafetyMaximum Post-Baseline Values: Liver Enzymes for Combination Therapy
collected from the start of BG00012 administration through to Week 26 +/- 5 days
Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy
collected from the start of BG00012 administration through to Week 26 +/- 5 days
Who could take part
Relapsing MS · 18 to 55 · EDSS 0.0 to 5.0
Show the full criteria
Inclusion criteria
Key Inclusion Criteria: * Must have a confirmed diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to McDonald criteria #1-4 (Polman et al, 2005 [Appendix I]), and have a prior brain magnetic resonance imaging (MRI) demonstrating lesion (s) consistent with multiple sclerosis (MS) from any point in time. * Must have an Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, inclusive. * Must be taking the same dose of a prescribed IFNβ (either Avonex, Betaseron, Rebif) or GA for at least 12 months consecutively at the time of enrollment and remain on this treatment for the duration of the study. Participants receiving Rebif must be prescribed 44 μg by subcutaneous injection three times per week. Key Exclusion Criteria: * Primary progressive, secondary progressive, or progressive relapsing MS (as defined by Polman et al. 2005). * Other chronic disease of the immune system, malignancies, acute urologic, or pulmonary disease. * Pregnant or nursing women. * Participation within 6 months prior to study enrollment in any other drug, biologic, or device study. NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
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 primary objective of the study is to evaluate the safety and tolerability of BG00012 (dimethyl fumarate) administered in combination with interferon b (IFNß) or glatiramer acetate (GA) in participants with relapsing-remitting multiple sclerosis (RRMS).
Papers
Loading reviews and guidelines…
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History
Started
Jun 2010
Main results due
Mar 2012
Finished
Mar 2012
Results posted
Jun 2015
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