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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 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.
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.
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
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04338022
The ClinicalTrials.gov registry entry for NCT04338022 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 1,124 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Teriflunomide is the first listed.
NCT04338022 reports 0 study locations.
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.
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