POINT
Research type
Research Study
Full title
Multicenter, randomized, double-blind, parallel-group, add-on, superiority 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®)
IRAS ID
206803
Contact name
Basil Sharrack
Contact email
Sponsor organisation
Actelion Pharmaceuticals Ltd.
Eudract number
2012-000541-12
Duration of Study in the UK
3 years, 4 months, 0 days
Research summary
This is a phase 3, double-blind, placebo-controlled, randomised study to compare the efficacy and safety of ponesimod against placebo in patients with active relapsing multiple sclerosis, who are currently being treated with dimethyl fumarate.
The purpose of the study is to test if the study drug is safe and effective at treating the disabilities associated with the patient’s multiple sclerosis.
About 600 people will participate in the study. Eligible patients will be randomly assigned to receive treatment with either placebo or ponesimod, alongside dimethyl fumerate. Patients who participate will be supplied tablets to taken orally once a day. After the treatment ends patients will return to their regular medical care for relapsing multiple sclerosis.
A number of assessments and procedures will be performed during the study including physical examinations, blood sample collection, quality of life questionnaires, urine sample collection, eye and skin exams, chest X-rays, MRI’s, electrocardiograms (ECG) and lung function tests. These assessments are performed as part of the evaluation to determine if the study drug is safe and effective.
The study will be run at approximately 6 centres in the UK and is sponsored by Actelion Pharmaceuticals Ltd.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
17/EM/0155
Date of REC Opinion
27 Jun 2017
REC opinion
Further Information Favourable Opinion