NCT07067463
A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
Recruiting
PHASE3Ages 18–60InterventionalTreatmentZenas BioPharma (USA), LLC
~705 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:OrelabrutinibPlacebo
At a glance
Recruiting sites
53 of 53 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to onset of composite confirmed disability progression (cCDP) , confirmed over at least 12 weeks (12-week cCDP)
Measured over Up to approximately 120 weeks
Conditions
Where it's being run
53 sites across 34 statesPoland9
Serbia4
Georgia3
Arizona2
Florida2
Texas2
Bulgaria2
Wielkopolska2
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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.
What this trial measures
- Time to onset of composite confirmed disability progression (cCDP) , confirmed over at least 12 weeks (12-week cCDP)Up 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, OR * ≥ 20% increase in the Timed 25-Foot Walk Test (T25FWT), OR * ≥ 20% increase in the 9-hole Peg Test (9HPT)