RecruitingPhase 3NCT07067463

A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis

A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Primary Progressive Multiple Sclerosis


Sponsor

Zenas BioPharma (USA), LLC

Enrollment

705 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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 randomization (orelabrutinib: placebo), globally.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called orelabrutinib — which blocks a protein involved in immune cell activity — can slow disability progression in people with primary progressive multiple sclerosis (PPMS), a form of MS that gradually worsens without relapses. **You may be eligible if...** - You are 18 to 60 years old - You have been diagnosed with primary progressive MS (PPMS) based on current medical criteria - Your disability has been documented as worsening in the past 24 months - Your disability score (EDSS) is between 3.0 and 6.5 **You may NOT be eligible if...** - You have a different form of MS (relapsing-remitting or secondary progressive) - You have another immune or neurological disease - You have had a malignancy in the past 5 years - You are on blood thinners or antiplatelet drugs - You have had alcohol or drug abuse issues in the past year - You have had a live vaccine within the past month Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOrelabrutinib

Orally

DRUGPlacebo

Orally


Locations(2)

Neurology Associates, PA

Maitland, Florida, United States

Premier Neurology

Greenville, South Carolina, United States

View Full Details on ClinicalTrials.gov

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NCT07067463


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