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A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared with Teriflunomide in Adult Patients with Relapsing Multiple Sclerosis
EU CTIS ID: 2022-502609-14-00
What this study is testing
To evaluate the efficacy of fenebrutinib compared with teriflunomide on the basis of annualized relapse rate (ARR)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Expanded Disability Status Scale score (EDSS) of 0.0-5.5 at screening
- 2. A diagnosis of RMS in accordance with the revised 2017 McDonald Criteria
- 3. Neurologically stable for at least 30 days prior to randomization and baseline assessments
- 4. Ability to complete the 9-HPT for each hand in < 240 seconds
- 5. Ability to perform the timed 25-Foot Walk Test in <150 seconds
- 6. OLE Inclusion Criteria: Completed the Double-Blind Treatment (DBT) phase of the study (remaining on study treatment; no other Disease-Modifying Therapy (DMT) administered) and who, in the opinion of the investigator, may benefit from treatment with fenebrutinib
You likely can't join if
- 1. A diagnosis of PPMS or non-active secondary progressive Multiple sclerosis (SPMS)
- 2. Disease duration of > 10 years from the onset of symptoms and an EDSS score at screening < 2.0
- 3. Any known or suspected active infection at screening or baseline, or any major episode of infection requiring hospitalization or treatment with IV anti-microbials within 8 weeks prior to and during screening or treatment with oral anti-microbials within 2 weeks prior to and during screening. Onychomycosis is not exclusionary unless it is being treated with systemic therapy
- 4. History of cancer including hematologic malignancy and solid tumors within 10 years of screening
- 5. Known presence of other neurological disorders that could interfere with the diagnosis of MS or assessments of efficacy or safety during the study, clinically significant cardiovascular, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic or gastrointestinal disease
- 6. Any concomitant disease that may require chronic treatment with systemic corticosteroids, or immunosuppressants during the course of the study
The study team makes the final eligibility decision.
Where it's taking place
- Panama
- China
- North Macedonia
- Canada
- Qatar
- Tunisia
- United States
- South Africa
- Kenya
- Russian Federation
- Serbia
- Georgia
- Dominican Republic
- Taiwan
- Argentina
- Brazil
- United Kingdom
- Switzerland
- Peru
- Morocco
+ 7 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Panama; China; North Macedonia; Canada; Qatar; Tunisia and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.