A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis

Part of paid clinical trials in Pheonix, Arizona.

Sponsor
Zenas BioPharma (USA), LLC
Study ID
NCT07067463
Phase
PHASE3
Status
Recruiting
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Conditions

  • Multiple Sclerosis (MS) Primary Progressive

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Orelabrutinib — DRUG
    Orally
  • Placebo — DRUG
    Orally

Study Details

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.

Key Dates

Start date
Mar 23, 2026
Status verified
May 2026
Primary completion
Jun 30, 2030
Completion
Jul 31, 2030

Study Design

Enrollment
705 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Orelabrutinib Group
  • Placebo Comparator: Placebo Group

Primary Outcome Measure

Time to onset of composite confirmed disability progression (cCDP) , confirmed over at least 12 weeks (12-week cCDP) [ Time Frame: Up to approximately 120 weeks ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Arizona Neuroscience Research, LLCPheonixArizona85032-
Perseverance Research CenterScottsdaleArizona85253-
Regina Berkovich MD, PhD Inc.West HollywoodCalifornia90048-
Nova Clinical Research, LLCBradentonFlorida34209-
Neurology Associates, PAMaitlandFlorida32751-
Washington University School of MedicineSt LouisMissouri63110-
Velocity Clinical Research, Raleigh NeurologyRaleighNorth Carolina27607-
Premier NeurologyGreenvilleSouth Carolina29605-
Neurology Clinic, P.C.CordovaTennessee38018-
Lone Star NeurologySan AntonioTexas78258-
Texas Institute for Neurological DisordersShermanTexas75092-

Find similar trials in Pheonix, AZ

By research site
Arizona Neuroscience Research, LLC· Pheonix, AZPerseverance Research Center· Scottsdale, AZRegina Berkovich MD, PhD Inc.· West Hollywood, CANova Clinical Research, LLC· Bradenton, FLNeurology Associates, PA· Maitland, FLWashington University School of Medicine· St Louis, MO

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