Orelabrutinib for Secondary Progressive Multiple Sclerosis

A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis

Recruiting Phase 3 Interventional Study
Secondary Progressive Multiple Sclerosis
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 60
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
990 (estimated)
Sponsor
Zenas BioPharma (USA), LLC · Industry
Who this trial is looking for

This trial is looking for people with Secondary Progressive Multiple Sclerosis who have not had a clinical relapse for at least 2 years. Participants will receive either orelabrutinib or a placebo for 1 to 5 years.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am between 18 and 60 years old.
  • I have been diagnosed with Relapsing-Remitting Multiple Sclerosis.
  • I currently have Secondary Progressive Multiple Sclerosis.
  • I have evidence of disability progression over the last 2 years.
  • I have not had any clinical relapses for at least 2 years.

You may not be able to join if

  • I have been diagnosed with Primary Progressive Multiple Sclerosis.
  • I have other serious immune disorders.
  • I have a history of neurological disorders that could be confused with MS.
  • I have a history of progressive multifocal leukoencephalopathy.
  • I have an active infection.
  • I have a serious active medical condition.
  • I have had suicidal behavior in the last 6 months.
  • I have a history of cancer.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 99…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. 18 to 60 years of age, inclusive, at the time of signing the informed consent. 2. Participant must have a previous diagnosis of RRMS in accordance with 2024 McDonald criteria 3. Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria …
Contacts

Patient and Medical Information

833-269-4696

clinicaltrialsinfo@zenasbio.com

CONTACT

Patient and Medical Information

833-269-4696

clinialtrialsinfo@zenasbio.com

CONTACT