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Study of Evobrutinib in Participants With Relapsing Multiple Sclerosis (RMS)

NCT04032158 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2021-08-05

Study results available
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Summary

The study was to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Interferon-beta-1a (Avonex®), once a week intramuscularly in participants with RMS.

Conditions

  • Relapsing-remitting Multiple Sclerosis

Interventions

DRUG

Evobrutinib

Participants received evobrutinib twice daily (BID).

DRUG

Avonex®

Participants received avonex® IM injection once a week.

DRUG

Avonex® matched Placebo

Participants received IM injection of placebo matched to Avonex® once a week.

DRUG

Evobrutinib matched Placebo

Participants received placebo matched to evobrutinib twice a day.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • EMD Serono Research & Development Institute, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-08-26
Primary Completion
2020-04-16
Completion
2020-04-16
FDA Drug
Yes

Countries

  • United States
  • Germany

Study Locations

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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 NCT04032158 on ClinicalTrials.gov