Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tol… (NCT04410991) | Clinical Trial Compass
CompletedPhase 3
Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)
United States899 participantsStarted 2020-06-11
Plain-language summary
Primary Objective:
To assess efficacy of daily SAR442168 compared to a daily dose of 14 mg teriflunomide (Aubagio) measured by annualized adjudicated relapse rate (ARR) in participants with relapsing forms of MS
Secondary Objective:
To assess efficacy of SAR442168 compared to teriflunomide (Aubagio) on disability progression, MRI lesions, cognitive performance and quality of life To evaluate the safety and tolerability of daily SAR442168 To evaluate pharmacodynamics (PD) of SAR442168
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria :
* The participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent
* The participant must have been diagnosed with RMS according to the 2017 revision of the McDonald diagnostic criteria
* The participant has an expanded disability status scale (EDSS) score ≤5.5 at the first Screening Visit
* The participant must have at least 1 of the following prior to screening:
* ≥1 documented relapse within the previous year OR
* ≥2 documented relapses within the previous 2 years, OR
* ≥1 documented Gd enhancing lesion on an MRI scan within the previous year
* Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
* Male participants are eligible to participate if they agree to the following during the intervention period and until accelerated elimination procedure:
* Refrain from donating sperm
Plus either:
* Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR
* Must agree to use contraception/barrier as detailed below
* Agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant
\- A fem…
What they're measuring
1
Annualized Relapse Rate (ARR) as Assessed by Confirmed Protocol-defined Adjudicated Relapses
Timeframe: Baseline (Day 1) to approximately 48 months