NCT03233230

Phase IIb Study of Evobrutinib in Subjects With Rheumatoid Arthritis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 390 (actual)
• Sponsor: EMD Serono Research & Development Institute, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	M2591 25 mg QD	Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 12 weeks.
DRUG	M2951 75 mg QD	Participants received 75 mg of M2951 orally QD for 12 weeks.
DRUG	M2951 50 mg BID	Participants received 50 mg of M2951 orally twice daily (BID) for 12 weeks.
DRUG	Placebo	Participants received placebo matched to M2951 orally for 12 weeks.

Timeline

• Start date: 2017-09-18
• Primary completion: 2019-09-23
• Completion: 2019-09-23
• First posted: 2017-07-28
• Last updated: 2020-09-28
• Results posted: 2020-09-28

Locations

98 sites across 12 countries: United States, Argentina, Bulgaria, Chile, Colombia, Czechia, Mexico, Poland, Russia, Serbia, South Africa, Ukraine

Regulatory

• FDA-regulated drug study