MSFrontier

A Study of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis (MS) EVOLVE-MS-1

A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis
CompletedPhase 3Relapsing MSNCT026343072015-005160-41

What it found

Results posted, no main test reported

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

Results by group

Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

From first dose to two weeks after last dose of study drug (Up to 98 weeks)

GroupValueIntervalNumber analysed
De Novo519 Participants593
Rollover: ALKS 8700212 Participants239
Rollover: DMF207 Participants225
De Novo69 Participants593
Rollover: ALKS 870029 Participants239
Rollover: DMF25 Participants225

Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities

From first dose to two weeks after last dose of study drug (Up to 98 weeks)

GroupValueIntervalNumber analysed
De Novo15 Participants582
Rollover: ALKS 87004 Participants238
Rollover: DMF2 Participants225
De Novo3 Participants582
Rollover: ALKS 87002 Participants238
Rollover: DMF1 Participants225
De Novo10 Participants582
Rollover: ALKS 87002 Participants238
Rollover: DMF4 Participants225
De Novo6 Participants582
Rollover: ALKS 87002 Participants238
Rollover: DMF2 Participants225
De Novo5 Participants582
Rollover: ALKS 87001 Participants238
Rollover: DMF2 Participants225
De Novo1 Participants582
Rollover: ALKS 87001 Participants238
Rollover: DMF2 Participants225

Number of Participants With Potentially Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities

From first dose to two weeks after last dose of study drug (Up to 98 weeks)

GroupValueIntervalNumber analysed
De Novo15 Participants576
Rollover: ALKS 87005 Participants237
Rollover: DMF6 Participants223
De Novo0 Participants576
Rollover: ALKS 87000 Participants237
Rollover: DMF1 Participants223

Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Score at Any Post-Baseline Visit

Up to 98 weeks

GroupValueIntervalNumber analysed
De Novo0 Participants593
Rollover: ALKS 87000 Participants239
Rollover: DMF0 Participants225
De Novo0 Participants593
Rollover: ALKS 87000 Participants239
Rollover: DMF0 Participants225
De Novo0 Participants593
Rollover: ALKS 87000 Participants239
Rollover: DMF0 Participants225
De Novo1 Participants593
Rollover: ALKS 87000 Participants239
Rollover: DMF0 Participants225
De Novo0 Participants593
Rollover: ALKS 87000 Participants239
Rollover: DMF0 Participants225
De Novo12 Participants593
Rollover: ALKS 87002 Participants239
Rollover: DMF4 Participants225
De Novo8 Participants593
Rollover: ALKS 87002 Participants239
Rollover: DMF2 Participants225
De Novo2 Participants593
Rollover: ALKS 87000 Participants239
Rollover: DMF1 Participants225
De Novo1 Participants593
Rollover: ALKS 87000 Participants239
Rollover: DMF0 Participants225
De Novo1 Participants593
Rollover: ALKS 87000 Participants239
Rollover: DMF0 Participants225
De Novo0 Participants593
Rollover: ALKS 87000 Participants239
Rollover: DMF0 Participants225

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities

From first dose to two weeks after last dose of study drug (Up to 98 weeks)

GroupValueIntervalNumber analysed
De Novo13 Participants582
Rollover: ALKS 87006 Participants238
Rollover: DMF1 Participants225
De Novo8 Participants582
Rollover: ALKS 87003 Participants238
Rollover: DMF1 Participants225
De Novo3 Participants582
Rollover: ALKS 87000 Participants238
Rollover: DMF0 Participants225
De Novo13 Participants582
Rollover: ALKS 87001 Participants238
Rollover: DMF3 Participants225
De Novo2 Participants582
Rollover: ALKS 87001 Participants238
Rollover: DMF0 Participants225
De Novo2 Participants582
Rollover: ALKS 87000 Participants238
Rollover: DMF0 Participants225
De Novo0 Participants582
Rollover: ALKS 87001 Participants238
Rollover: DMF0 Participants225
De Novo23 Participants582
Rollover: ALKS 87008 Participants238
Rollover: DMF8 Participants225
De Novo26 Participants582
Rollover: ALKS 870011 Participants238
Rollover: DMF8 Participants225
De Novo1 Participants582
Rollover: ALKS 87000 Participants238
Rollover: DMF0 Participants225
De Novo1 Participants582
Rollover: ALKS 87000 Participants238
Rollover: DMF2 Participants225
De Novo4 Participants582
Rollover: ALKS 87006 Participants238
Rollover: DMF4 Participants225
De Novo6 Participants582
Rollover: ALKS 87005 Participants238
Rollover: DMF4 Participants225
De Novo13 Participants582
Rollover: ALKS 87006 Participants238
Rollover: DMF3 Participants225
De Novo1 Participants582
Rollover: ALKS 87000 Participants238
Rollover: DMF0 Participants225
De Novo39 Participants582
Rollover: ALKS 87008 Participants238
Rollover: DMF16 Participants225
De Novo1 Participants582
Rollover: ALKS 87000 Participants238
Rollover: DMF0 Participants225
De Novo69 Participants582
Rollover: ALKS 870027 Participants238
Rollover: DMF29 Participants225
De Novo1 Participants582
Rollover: ALKS 87000 Participants238
Rollover: DMF0 Participants225
De Novo3 Participants582
Rollover: ALKS 87000 Participants238
Rollover: DMF0 Participants225
De Novo123 Participants582
Rollover: ALKS 870045 Participants238
Rollover: DMF61 Participants225
De Novo54 Participants582
Rollover: ALKS 870032 Participants238
Rollover: DMF24 Participants225
De Novo10 Participants582
Rollover: ALKS 87005 Participants238
Rollover: DMF2 Participants225
De Novo8 Participants582
Rollover: ALKS 87003 Participants238
Rollover: DMF4 Participants225
De Novo5 Participants582
Rollover: ALKS 87003 Participants238
Rollover: DMF2 Participants225
De Novo8 Participants582
Rollover: ALKS 87003 Participants238
Rollover: DMF1 Participants225
De Novo18 Participants582
Rollover: ALKS 87005 Participants238
Rollover: DMF8 Participants225
De Novo6 Participants582
Rollover: ALKS 87004 Participants238
Rollover: DMF3 Participants225
De Novo5 Participants582
Rollover: ALKS 87001 Participants238
Rollover: DMF3 Participants225
De Novo2 Participants582
Rollover: ALKS 87001 Participants238
Rollover: DMF0 Participants225
De Novo47 Participants582
Rollover: ALKS 870025 Participants238
Rollover: DMF24 Participants225
De Novo39 Participants582
Rollover: ALKS 870010 Participants238
Rollover: DMF13 Participants225
De Novo2 Participants582
Rollover: ALKS 87000 Participants238
Rollover: DMF1 Participants225
De Novo0 Participants582
Rollover: ALKS 87000 Participants238
Rollover: DMF0 Participants225
De Novo45 Participants582
Rollover: ALKS 870017 Participants238
Rollover: DMF15 Participants225
De Novo4 Participants582
Rollover: ALKS 87005 Participants238
Rollover: DMF5 Participants225
De Novo15 Participants582
Rollover: ALKS 87008 Participants238
Rollover: DMF5 Participants225
De Novo95 Participants582
Rollover: ALKS 870032 Participants238
Rollover: DMF31 Participants225
De Novo10 Participants582
Rollover: ALKS 87004 Participants238
Rollover: DMF3 Participants225
De Novo15 Participants582
Rollover: ALKS 87004 Participants238
Rollover: DMF9 Participants225

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
De Novo59369 (11.6%)3
Rollover: ALKS 870023929 (12.1%)1
Rollover: DMF22525 (11.1%)0

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 Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    From first dose to two weeks after last dose of study drug (Up to 98 weeks)

    Safety

  • Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities

    From first dose to two weeks after last dose of study drug (Up to 98 weeks)

    Safety

  • Number of Participants With Potentially Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities

    From first dose to two weeks after last dose of study drug (Up to 98 weeks)

  • Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Score at Any Post-Baseline Visit

    Up to 98 weeks

  • Number of Participants With Potentially Clinically Significant Laboratory Abnormalities

    From first dose to two weeks after last dose of study drug (Up to 98 weeks)

    Immune responseSafety

  • - Safety will be demonstrated by incidence of Adverse Events

    Safety

Other measures (1)

  • Other endpoints

Who could take part

Relapsing MS · 18 to 65

Key Inclusion Criteria: * Has a confirmed diagnosis of RRMS * Neurologically stable with no evidence of relapse within 30 days prior to Visit 2 Exclusion Criteria: * Subject is pregnant or breastfeeding or plans to become pregnant or begin breastfeeding at any point during the study and for 30 days after any study drug administration * Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS * History of clinically significant cardiovascular, pulmonary, gastrointestinal, dermatologic, psychiatric, neurologic (other than MS), and/or other major disease that would preclude participation in a clinical trial * History of a myocardial infarction, including a silent myocardial infarction identified on ECG, or unstable angina NOTE: Other protocol defined Includison/Exclusion criteria may apply.

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 this study is to evaluate the long-term safety and tolerability of ALKS 8700 for the treatment of Relapsing Remitting Multiple Sclerosis (RRMS). The secondary objective of this study is to evaluate treatment effect over time in adult participants with RRMS treated with ALKS 8700.

Papers

Loading reviews and guidelines…

Related trials

History

    1. Started

      Dec 2015

    2. Main results due

      Jun 2021

    3. Finished

      Nov 2021

    4. Results posted

      Jun 2022

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