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RecruitingPhase 3

A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis

Zenas BioPharma (USA), LLC · NCT07299019

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–60 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
990
US sites recruiting
25
Study start
March 23, 2026
Record last updated
October 21, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Orelabrutinib; Placebo

Conditions: Secondary Progressive Multiple Sclerosis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 18 to 60 years of age, inclusive, at the time of signing the informed consent.
  • Participant must have a previous diagnosis of RRMS in accordance with 2024 McDonald criteria
  • Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013
  • Participant must have documented evidence of disability progression independent of clinical relapse observed during the 24 months before screening. A written summary of the clinical evidence of disability progression must be discussed and aligned between the Investigator and the Sponsor's dedicated qualified person(s).
  • Absence of clinical relapses for at least 24 months.

Exclusion Criteria

  • The patient has been diagnosed with primary progressive MS (PPMS) according to 2024 McDonald diagnostic criteria
  • Immunologic disorder other than MS or any other conditions requiring corticosteroid therapy.
  • History or current diagnosis of other neurological disorders that may mimic MS
  • History or current diagnosis of progressive multifocal leukoencephalopathy
  • Active, clinically significant viral, bacterial, or fungal infection
  • History of any other significant active medical condition
  • History of suicidal behavior within 6 months prior to Screening
  • Any prior history of malignancy
  • Patients on anticoagulation, or antiplatelet therapy
  • Patients took strong/moderate CYP3A inhibitors or strong/moderate CYP3A inducers within 14 days
  • Clinically significant laboratory abnormalities at Screening.
  • 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.

Recruiting US locations

Study contacts (from the official record)

  • Patient and Medical Information · 833-269-4696 · clinicaltrialsinfo@zenasbio.com
  • Patient and Medical Information · 833-269-4696 · clinialtrialsinfo@zenasbio.com
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A Study of Orelabrutinib in Patients With Secondary Progressive… (NCT07299019) | Bored Studies