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RecruitingPhase 3

A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis

Zenas BioPharma (USA), LLC · NCT07067463

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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
705
US sites recruiting
19
Study start
March 23, 2026
Record last updated
October 20, 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 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.

Being studied: Orelabrutinib; Placebo

Conditions: Multiple Sclerosis (MS) Primary Progressive

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
  • 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.

Recruiting US locations

Study contacts (from the official record)

  • Patient and Medical Information · 833-269-4696 · clinicaltrialsinfo@zenasbio.com
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A Study of Orelabrutinib in Patients With Primary Progressive… (NCT07067463) | Bored Studies