A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis

Conditions

• Secondary Progressive Multiple Sclerosis

Eligibility Criteria

Sex

ALL

Age

18 Years - 60 Years

Healthy Volunteers

Not accepted

Interventions

• Orelabrutinib — DRUG
  Orelabrutinib orally
• Placebo — DRUG
  Placebo orally

Study Details

Orelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of orelabrutinib compared with placebo in patients with non-active Secondary Progress MS. Patients will be treated for approximately 24 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 990 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.

Key Dates

First listed

Dec 23, 2025

Start date

Mar 23, 2026

Status verified

Aug 2026

Primary completion

Jun 30, 2030

Completion

Jul 31, 2030

Study Design

Enrollment

990 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Orelabrutinib Group
  Orelabrutinib PO daily
• Placebo Comparator: Placebo Group
  Placebo PO daily

Primary Outcome Measure

Time to onset of confirmed disability progression (CDP) events, confirmed over at least 24 weeks [ Time Frame: Up to approximately 120 weeks ]

Central Contacts

• Patient and Medical Information
  833-269-4696
  [email protected]
• Patient and Medical Information
  833-269-4696
  [email protected]

Locations (20)

Find similar trials in Phoenix, AZ

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