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Phase 3 Study of Orelabrutinib for Secondary Progressive Multiple Sclerosis

This study is testing a drug called orelabrutinib against a placebo (an inactive substance) in people with non-active Secondary Progressive Multiple Sclerosis (SPMS). Orelabrutinib is a type of medicine that can reach the central nervous system (brain and spinal cord). The main goal is to see if orelabrutinib can slow down the worsening of disability over approximately 24 to 120 weeks. You may be able to join if you are between 18 and 60 years old and have a diagnosis of both Relapsing-Remitting MS (RRMS) and SPMS. The study aims to enroll about 990 people globally to see how well orelabrutinib works and if it is safe.

Study design
This is a Phase 3, randomized, double-blind study, meaning participants are randomly assigned to receive either orelabrutinib or placebo, and neither you nor your doctor will know which you are receiving. Approximately 990 participants will be enrolled worldwide.
What's involved
You would participate in the study for approximately 24 to 60 months, with a minimum treatment duration of 12 months.
Compensation
Not stated in the trial record.
Follow-up
After treatment, there will be a safety follow-up period lasting 4 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07299019

A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis

Recruiting
PHASE3Ages 18–60InterventionalTreatment
Zenas BioPharma (USA), LLC
~990 participants
Updated 2026-09-15 on ClinicalTrials.gov
What's tested:OrelabrutinibPlacebo

At a glance

Recruiting sites
43 of 44 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to onset of confirmed disability progression (CDP) events, confirmed over at least 24 weeks
Measured over Up to approximately 120 weeks

Conditions

Secondary Progressive Multiple Sclerosis

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NCT07299019

Where you'd take part

This study runs at 44 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Aqualane Clinical Research

    Naples, Floridano site contact published

    Recruiting

  • Arizona Neuroscience Research, LLC

    Phoenix, Arizonano site contact published

    Recruiting

  • Astra clinic (Clinic4U)

    Tallinn, Harju, Estoniano site contact published

    Recruiting

  • Caribbean Center for Clinical Research

    Guaynabo, Puerto Ricono site contact published

    Recruiting

  • Centrum Medyczne INTERCOR Sp. z o.o.

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Polandno site contact published

    Recruiting

  • Diagnostic and Consultative Center Convex

    Sofia, Sofia, Bulgariano site contact published

    Recruiting

  • EUROMEDIS Osrodek Badan Klinicznych

    Szczecin, Polandno site contact published

    Recruiting

  • Fullerton Neurology and Headache Center

    Fullerton, Californiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Patient and Medical Information
[email protected]
833-269-4696
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

What this trial measures

  • Time to onset of confirmed disability progression (CDP) events, confirmed over at least 24 weeksUp to approximately 120 weeks

    Expanded disability status scale (EDSS) score increase ≥ 1.0 point from baseline when the baseline score is ≤ 5.0, or ≥ 0.5 points from baseline when the baseline score is \> 5.0