Orelabrutinib for Primary Progressive Multiple Sclerosis

A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis

Recruiting Phase 3 Interventional Study
Multiple Sclerosis (MS) Primary Progressive
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
705 (estimated)
Sponsor
Zenas BioPharma (USA), LLC · Industry
Who this trial is looking for

This trial is looking for people with Primary Progressive Multiple Sclerosis (PPMS). Participants will take either the study drug orelabrutinib or a placebo for about 30 to 60 months, with at least 12 months of treatment.

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 Primary Progressive MS.
  • I have evidence of disability progression in the last 24 months.
  • My EDSS score is between 3.0 and 6.5.

You may not be able to join if

  • I have been diagnosed with relapsing-remitting MS or secondary progressive MS.
  • I have an immunologic disorder other than MS.
  • I have a history of other neurological disorders that may mimic MS.
  • I have a history of significant active medical conditions.
  • I have had suicidal behavior in the past 6 months.
  • I have a history of cancer that recurred within the last 5 years.
  • I am taking anticoagulation or antiplatelet therapy.
  • I have a history of alcohol or drug abuse in the past 12 months.

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.

Think this trial could be right for you?

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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 PPMS. Patients will be treated for approximately 30 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 705 subjects in a 2:1 randomiz…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 18 to 60 years of age, inclusive * Diagnosed with Primary Progressive MS (PPMS) according to 2017 McDonald criteria * Participant must have documented evidence of disability progression observed during the 24 months before screening. * Expanded disability status scale (EDSS) s…
Contacts

Patient and Medical Information

833-269-4696

clinicaltrialsinfo@zenasbio.com

CONTACT