Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (HERCULES)

Conditions

• Non-relapsing Secondary Progressive Multiple Sclerosis

Eligibility Criteria

Sex

ALL

Age

18 Years - 60 Years

Healthy Volunteers

Not accepted

Interventions

• Tolebrutinib — DRUG
  Pharmaceutical form: Film-coated tablet Route of administration: Oral
• Placebo to match Tolebrutinib — 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 NRSPMS Secondary Objective: 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 and relevant metabolites in NRSPMS and its relationship to efficacy and safety To evaluate pharmacodynamics (PD) of SAR442168

Key Dates

Start date

Sep 24, 2020

Status verified

Jun 2025

Primary completion

Aug 29, 2024

Completion

Aug 29, 2024

Study Design

Enrollment

1,131 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: SAR442168
  60 mg of oral SAR442168 once daily
• Placebo Comparator: Placebo
  Placebo tablet to match SAR442168 once daily

Primary Outcome Measure

Time to Onset of 6-Month Confirmed Disability Progression (CDP) as Assessed by Expanded Disability Status Scale (EDSS) [ Time Frame: Baseline (Day 1) up to approximately 47 months ]

Locations (51)

Related coverage on Hipa.ai

• Tolebrutinib Reduces Disability Progression and Lesions in NRSPMS
  Tolebrutinib · Jun 18, 2025 · ClinicalTrials.gov

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