A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

Conditions

• Secondary Progressive Multiple Sclerosis (SPMS)

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Remibrutinib (blinded) — DRUG
  Remibrutinib (Blinded) active treatment, oral tablet
• Placebo — DRUG
  Matching placebo (binded), oral tablet
• Remibrutinib (Open label) — DRUG
  Remibrutinib (Open Label), oral tablet

Study Details

The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)

Key Dates

First listed

Nov 6, 2025

Start date

Nov 11, 2025

Status verified

Jul 2026

Primary completion

Dec 3, 2030

Completion

Jan 2, 2034

Study Design

Enrollment

1,275 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Remibrutinib (LOU064)
  Core Part: Remibrutinib film-coated tablet taken orally \[Extension Part: Open-label remibrutinib film-coated tablet taken orally\]
• Placebo Comparator: Placebo
  Core Part: Matching placebo film-coated tablet taken orally \[Extension Part: Open-label remibrutinib film-coated tablet taken orally\]

Primary Outcome Measure

Time to 6-month confirmed disability progression (6mCDP) on Expanded Disability Status Scale (EDSS) [ Time Frame: From baseline up to approximately 5 years ]

Central Contacts

• Novartis Pharmaceuticals
  1-888-669-6682
  [email protected]
• Novartis Pharmaceuticals
  +41613241111

Locations (35)

Find similar trials in Birmingham, AL

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