Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsin… (NCT04586023) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
United States751 participantsStarted 2021-03-24
Plain-language summary
A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS. Eligible participants will be randomized in a 1:1 ratio to receive either fenebrutinib or teriflunomide. At the end of the double-blind treatment (DBT) phase (after disclosure of the DBT results), the Sponsor will determine whether or not to initiate the open-label extension (OLE) phase of the study.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion Criteria:
* Expanded Disability Status Scale (EDSS) score of 0 - 5.5 at screening
* A diagnosis of RMS in accordance with the revised 2017 McDonald Criteria
* Ability to complete the 9-hole Peg Test (9-HPT) for each hand in \< 240 seconds
* Ability to perform the Timed 25-foot Walk Test (T25FWT) in \< 150 seconds
* For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating eggs
* For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating sperm
OLE Inclusion Criteria:
* Completed the 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
* Participants randomized to the teriflunomide treatment arm during the DBT phase must undergo the accelerated teriflunomide elimination procedure (ATEP) prior to the first administration of open-label fenebrutinib
* For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating eggs
* For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating sperm
Exclusion Criteria:
* Disease …