CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 390 enrolled
Drug / intervention
M2591 25 mg QD +3 moredrug
Likely dose
M2591 25 mg QDfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03233230
NCT03233230Phase 2Completed
CompareCT.gov

A Phase IIb, Randomized, Double-blind Study in Subjects With Rheumatoid Arthritis Evaluating the Safety and Efficacy of Evobrutinib Compared With Placebo in Subjects With an Inadequate Response to Methotrexate

EMD Serono Research & Development Institute, Inc.·interventional·Posted Jul 28, 2017·Updated Sep 28, 2020

In Brief

A Phase 2 clinical trial evaluating M2591 25 mg QD, M2951 75 mg QD, and 2 other interventions for Rheumatoid Arthritis. Completed, enrolled 390 participants across 98 sites in 12 countries.

Detailed Summary

The purpose of this study was to determine the efficacy, dose response, and safety of M52951 in participants with Rheumatoid Arthritis (RA), and to consider a dose to took forward into Phase III development.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Bulgaria, Chile, Colombia, Czechia, Mexico, Poland, Russia, Serbia, South Africa, Ukraine, United States
CollaboratorsMerck KGaA, Darmstadt, Germany

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJul 28, 2017
Enrollment StartSep 18, 2017
Primary CompletionSep 23, 2019
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 8.9 years ago

Interventions

M2591 25 mg QDdrug

Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 12 weeks.

M2951 75 mg QDdrug

Participants received 75 mg of M2951 orally QD for 12 weeks.

M2951 50 mg BIDdrug

Participants received 50 mg of M2951 orally twice daily (BID) for 12 weeks.

Placebodrug

Participants received placebo matched to M2951 orally for 12 weeks.