Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)

Conditions

• Primary Progressive Multiple Sclerosis

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Not accepted

Interventions

• Tolebrutinib — DRUG
  Pharmaceutical form: Film-coated Tablet Route of administration: Oral
• Placebo — DRUG
  Pharmaceutical form: Film-coated Tablet Route of administration: Oral

Study Details

Primary Objective: To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in primary progressive multiple sclerosis (PPMS) Secondary Objectives: To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of life To evaluate safety and tolerability of SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 in PPMS and its relationship to efficacy and safety To evaluate pharmacodynamics of SAR442168

Key Dates

Start date

Aug 13, 2020

Status verified

Jan 2026

Primary completion

Nov 14, 2025

Completion

Nov 14, 2025

Study Design

Enrollment

767 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: SAR442168
  Dose 1 of oral SAR442168 once daily
• Placebo Comparator: Placebo
  Placebo to match the SAR442168 once daily

Primary Outcome Measure

6-month composite Confirmed Disability Progression (cCDP) [ Time Frame: Up to approximately 60 months ]

Locations (45)

Related coverage on Hipa.ai

• Tolebrutinib Phase 3 PERSEUS Trial for PPMS Reaches Primary Completion
  Tolebrutinib · Nov 14, 2025 · ClinicalTrials.gov

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