MedTrace Logo

A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis

NCT07067463 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 705

Last updated 2026-05-18

No results posted yet for this study

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.

Conditions

  • Multiple Sclerosis (MS) Primary Progressive

Interventions

DRUG

Orelabrutinib

Orally

DRUG

Placebo

Orally

Sponsors & Collaborators

  • Zenas BioPharma (USA), LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-23
Primary Completion
2030-06-30
Completion
2030-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07067463 on ClinicalTrials.gov