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Clinical Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®)

NCT02907177 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2021-05-18

Study results available
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Summary

This clinical study compares the efficacy, safety, and tolerability of therapy with ponesimod vs placebo in subjects with active RMS who are treated with DMF (Tecfidera®).

Conditions

Interventions

DRUG

Ponesimod

One tablet of ponesimod 20 mg administered orally once daily in the morning from Day 15 to EOT. To reduce the first-dose effect of ponesimod, an uptitration scheme will be implemented from Day 1 to Day 14 (with dose strength increasing from 2 mg to 20 mg).

OTHER

Placebo

One tablet of matching placebo administered orally once daily in the morning

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Principal Investigators

  • Tatiana Scherz, MD, PhD · Actelion

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
2017-03-30
Primary Completion
2020-03-26
Completion
2020-03-26
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Mexico
  • Poland
  • Portugal
  • Russia
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT02907177 on ClinicalTrials.gov