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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.

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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

FieldValue
Enrollment Target 1,124 participants
Start Date 2020-06-12
Est. Completion 2024-03-08
Phase Phase 3

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.