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NCT04032158 · ClinicalTrials.gov registry record · Phase 3
Study of Evobrutinib in Participants With Relapsing Multiple Sclerosis (RMS)
A Phase 3 study, sponsored by EMD Serono Research & Development Institute.
- Terminated
- Registry status
- Phase 3
- Development phase
- 3
- Enrollment target
NCT04032158: Clinical Trial Phase 3 study, sponsored by EMD Serono Research & Development Institute.
NCT04032158 is a Phase 3 study that was terminated before completion, run by EMD Serono Research & Development Institute. The registered enrollment target is 3 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04032158, a Phase 3 study, was terminated before completion, sponsored by EMD Serono Research & Development Institute.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 3 participants
- Enrollment target
Study Summary
The study was to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Interferon-beta-1a (Avonex®), once a week intramuscularly in participants with RMS.
Primary Outcome
The annualized relapse rate at 96 weeks was to be calculated based on qualified relapses. A qualifying relapse is the occurrence of new or worsening neurological symptoms attributable to MS. The relapse should be accompanied by an increase of 0.5 points or more on Expanded Disability Status Scale (EDSS), or 2 points increase on one of the Functional System Scores (FSS), or 1 point increase on at least two of the FSS. The increase in FSS scores must be related to the neurological symptoms which w
Interventions
- DRUG Avonex®
- DRUG Evobrutinib
- DRUG Avonex® matched Placebo
- DRUG Evobrutinib matched Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2019-08-26 |
| Est. Completion | 2020-04-16 |
| Phase | Phase 3 |
Why NCT04032158 stopped before completion
NCT04032158 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 4 interventions - of which Avonex® is the first listed.
NCT04032158 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04032158 about?
NCT04032158 is a clinical study titled "Study of Evobrutinib in Participants With Relapsing Multiple Sclerosis (RMS)". The study was to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Interferon-beta-1a (Avonex®), once a week intramuscularly in participants with RMS.
What is the current status of trial NCT04032158?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 3 participants. The study started on 2019-08-26. Estimated completion is 2020-04-16.
What interventions are being tested in trial NCT04032158?
The interventions under investigation include: Avonex® (DRUG), Evobrutinib (DRUG), Avonex® matched Placebo (DRUG), Evobrutinib matched Placebo (DRUG).
Who is sponsoring clinical trial NCT04032158?
This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04032158's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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