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®)

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®).

Timeline

Start

2017-03-30

Primary completion

2020-03-26

Completion

2020-03-26

Outcome

Missed primary endpoint

Stopped (Enrollment): “sponsor decision due to low recruitment”

paper Primary endpoint (ARR) was not met (rate ratio, ponesimod+DMF versus placebo+DMF: 1.2; p = 0.5252). PMID 40700861 ↗

registry analysis (superiority test); Ponesimod Plus Dimethyl Fumarate (DMF) vs Placebo Plus Dimethyl Fumarate (DMF); p = 0.5252; NCT02907177 ↗

Publications

• Kappos L, Burcklen M, D'Ambrosio D, Fox RJ, Freedman MS, Havrdova EK, Hennessy B, Hohlfeld R, Larbalestier A, Lemle A, Lindenstrom E, Lublin F, Montalban X, Sidorenko T, Sprenger T, Vaclavkova A, Wuerfel J, Pozzilli C. Ponesimod as add-on treatment in patients with active relapsing multiple sclerosis under dimethyl fumarate (POINT): A phase 3, randomized, placebo-controlled clinical trial. Mult Scler Relat Disord. 2025 Oct;102:106616. doi: 10.1016/j.msard.2025.106616. Epub 2025 Jul 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ponesimod	Small molecule	20 mg	Oral

Indications