Orelabrutinib treatment for primary progressive multiple sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a global phase 3, randomized, double-blind, parallel-group, multicenter trial comparing orelabrutinib to placebo in people with primary progressive MS. About 705 participants will be randomized 2:1 (active:placebo) and treated for roughly 30 to 60 months with a minimum of 12 months on study drug. The trial enrolls adults 18–60 years old with confirmed PPMS, documented disability progression in the prior 24 months, and EDSS between 3.0 and 6.5. Efficacy and safety outcomes will be compared between groups to determine whether orelabrutinib alters the course of disability.

Why it matters

Who can join: the full rules

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) score between 3.0 to 6.5 points, inclusive, at Screening.

Exclusion Criteria:

* Diagnosed with relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS)
* Immunologic disorder other than MS or any other conditions requiring oral, intravenous (IV), intramuscular, or intra-articular corticosteroid therapy.
* History or current diagnosis of other neurological disorders that may mimic MS
* History of any other significant active medical condition
* History of suicidal behavior within 6 months prior to Screening
* Any prior history of malignancy if no recurrence within 5 years
* Patients on anticoagulation, or antiplatelet therapy will be excluded
* Patients took strong/moderate CYP3A inhibitors or strong/moderate CYP3A inducerswithin 14 days
* Clinically significant laboratory abnormalities at Screening.
* Any allergy, contraindication, or inability to tolerate orelabrutinib or any of the excipients in the study intervention
* Vaccination with live or live-attenuated virus vaccine within 1 month prior to Screening
* History of alcohol abuse or alcohol use disorder or other drug abuse within 12 months prior to screening.

Where it's running

• Arizona Neuroscience Research, LLC
  Pheonix, Arizona, United States Recruiting
• Perseverance Research Center
  Scottsdale, Arizona, United States Recruiting
• Regina Berkovich MD, PhD Inc.
  West Hollywood, California, United States Recruiting
• Nova Clinical Research, LLC
  Bradenton, Florida, United States Recruiting
• Neurology Associates, PA
  Maitland, Florida, United States Recruiting
• Neurological Services of Orlando
  Orlando, Florida, United States Recruiting

+36 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Patient and Medical Information
• Email: clinicaltrialsinfo@zenasbio.com
• Phone: 833-269-4696

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• REAL-MS: A Look at Autologous Stem Cell Transplant vs High-Efficacy MS Therapies in Real-World Care

  This study tests how AHSCT compares to high-efficacy MS medicines in adults treated in routine clinical care.

  Recruiting Imperial College London · London and 2 other locations · NCT07899502

• Orelabrutinib plus Pola-R-CHP as first-line treatment for intermediate- to high-risk DLBCL

  This trial tests whether adding orelabrutinib to the Pola-R-CHP regimen can improve outcomes for adults with intermediate- to high-risk newly diagnosed DLBCL.

  Recruiting at 2 sites The First Affiliated Hospital of Xiamen University · Xiamen, Fujian and 1 other locations · NCT07778212

• Orelabrutinib with Obinutuzumab and Short-Course Venetoclax in Treatment-Naïve Mantle Cell Lymphoma

  This trial tests whether a combo of orelabrutinib, obinutuzumab, and a short course of venetoclax is safe and effective for adults with newly diagnosed mantle cell lymphoma.

  Recruiting at 2 sites Phase 2 The First Affiliated Hospital with Nanjing Medical University · Changzhou, Jiangsu and 1 other locations · NCT07719556

• Orelabrutinib plus standard immunochemotherapy with or without auto-HSCT for newly diagnosed DLBCL

  This study tests whether adding orelabrutinib to standard chemotherapy, with or without autologous stem cell transplantation, helps newly diagnosed DLBCL patients.

  Recruiting Phase 2 The Affiliated Hospital of Xuzhou Medical University · Xuzhou, Jiangsu · NCT07680933

• Safety and dosing of S103 cells in progressive or refractory multiple sclerosis

  This trial tests S103 BCMA-CAR T cells in adults with progressive or refractory MS to see if it can be safely given and hint at benefit.

  Recruiting Phase 1 Xijing Hospital · Xi'an, Shaanxi · NCT07587125

• High-dose dexamethasone plus orelabrutinib versus placebo for newly diagnosed adult ITP

  This trial tests whether adding orelabrutinib to high-dose dexamethasone helps adults newly diagnosed with primary ITP raise and maintain their platelet counts compared with placebo.

  Recruiting Phase 3 Shandong University · Jinan, Shandong · NCT07559331

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.