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NCT04338022 · ClinicalTrials.gov registry record · Phase 3
Study of Evobrutinib in Participants With RMS (evolutionRMS 1)
A Phase 3 study, sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1,124
- Enrollment target
NCT04338022: Clinical Trial Phase 3 study, sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany.
NCT04338022 is a Phase 3 study that was terminated before completion, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany. The registered enrollment target is 1,124 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04338022, a Phase 3 study, was terminated before completion, sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1,124 participants
- Enrollment target
Study Summary
The study is to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Teriflunomide (Aubagio®), administered orally once daily in participants with Relapsing Multiple Sclerosis (RMS). Participants who complete the double-blind treatment period (DBTP) and double-blind extension period (DBEP) prior to approval of a separate long-term follow-up study in their country will get an option for evobrutinib treatment continuation through a 96-week open-label extension (OLE) period.
Primary Outcome
The qualifying relapse is the occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis (MS) (for more than \[\>\] 24 hours, no fever, infection, injury, adverse events (AEs,) and preceded by a stable or improving neurological state for more than or equal to \[\>=\] 30 days).
Interventions
- DRUG Teriflunomide
- DRUG Evobrutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,124 participants |
| Start Date | 2020-06-12 |
| Est. Completion | 2024-03-08 |
| Phase | Phase 3 |
Sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany4 total trials
Why NCT04338022 stopped before completion
NCT04338022 is an interventional study that assigns participants to a tested intervention. Its 1,124 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% higher).
The record links to 0 conditions, and to 2 interventions - of which Teriflunomide is the first listed.
NCT04338022 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04338022 about?
NCT04338022 is a clinical study titled "Study of Evobrutinib in Participants With RMS (evolutionRMS 1)". The study is to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Teriflunomide (Aubagio®), administered orally once daily in participants with Relapsing Multiple Sclerosis (RMS). Participants who complete the double-blind treatment period (DBTP) and double-blind...
What is the current status of trial NCT04338022?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,124 participants. The study started on 2020-06-12. Estimated completion is 2024-03-08.
What interventions are being tested in trial NCT04338022?
The interventions under investigation include: Teriflunomide (DRUG), Evobrutinib (DRUG).
Who is sponsoring clinical trial NCT04338022?
This trial is sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04338022's enrollment target sits among peer trials
1,124 248th of 2000 higher than 1,753 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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