Search > Multiple Sclerosis
990 Participants NeededMy employer runs this trial

Orelabrutinib for Multiple Sclerosis

Recruiting at 4 trial locations
Pa
Overseen ByPatient and Medical Information
Age: 18 - 65
Sex: Any
Trial Phase: Phase 3
Sponsor: Zenas BioPharma (USA), LLC
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of 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 990 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 18 and 60 years old.
I have been diagnosed with RRMS according to the 2024 McDonald criteria.
I haven't had any symptoms of my condition worsen in the last 2 years.
See 2 more

What Are the Treatments Tested in This Trial?

Interventions

  • Orelabrutinib

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Orelabrutinib GroupExperimental Treatment1 Intervention
Group II: Placebo GroupPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Zenas BioPharma (USA), LLC

Lead Sponsor

Trials
8
Recruited
760+

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