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Phase IIb Study of Evobrutinib in Subjects With Rheumatoid Arthritis

NCT03233230 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2020-09-28

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • EMD Serono Research & Development Institute, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · EMD Serono Research & Development Institute, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-18
Primary Completion
2019-09-23
Completion
2019-09-23
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Bulgaria
  • Chile
  • Colombia
  • Czechia
  • Mexico
  • Poland
  • Russia
  • Serbia
  • South Africa
  • Ukraine

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03233230 on ClinicalTrials.gov