Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
Phase 3: testing Orelabrutinib for Multiple Sclerosis (MS) Primary Progressive
Orelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomly assigned, neither you nor the study doctors know who gets the real treatment, parallel-group, multicenter study to measure the how well it works and safety of orelabrutinib compared with dummy treatment (placebo) in patients with PPMS.
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Orelabrutinib, or Placebo. The registry lists allocation as randomized. Orelabrutinib is a CNS-penetrable BTK inhibitor.
They plan to enroll about 705 people at 86 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Primary Progressive Multiple Sclerosis
Interventions: Orelabrutinib, Placebo
Primary outcome (registry wording): Time to onset of composite confirmed disability progression (cCDP) , confirmed over at least 12 weeks (12-week cCDP)
Who it is for (from inclusion criteria)
Ages 18 Years to 60 Years
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
Who the registry excludes
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
Inflammatory or degenerative diseases of the brain and spinal cord, such as multiple sclerosis, may be related to problems with an individual s immune system. However, more information is needed on the ways in which the cells of the immune system interact with the central nervous system (CNS).
The specific aims of the study are: Primary: To determine the presence and regional distribution of microglial activation, as assessed by Fluorine-18 (18F) labeled "Peripheral Benzodiazepine Receptor 06" (PBR06) -PET, in subjects with active Relapsing Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS), and Alzheimer's Disease (AD) as compared to healthy controls Secondary: 1. To assess the relationship between microglial activation and clinical variables including disease severity and comorbidities (such as pain, fatigue and/or depression), as well as clinical MRI findings (such as lesions and atrophy) 2.
This is a multi-center prospective rater-masked (blinded) randomly assigned controlled trial of 156 participants, comparing the treatment strategy of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) to the treatment strategy of Best Available Therapy (BAT) for treatment-resistant relapsing multiple sclerosis (MS). you would be randomly assigned at a 1 to 1 (1:1) ratio.
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07067463?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07067463?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.