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 Secondary Progressive Multiple Sclerosis
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 non-active Secondary Progress MS.
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 990 people at 90 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 Non-active Secondary Progressive Multiple Sclerosis
Interventions: Orelabrutinib, Placebo
Primary outcome (registry wording): Time to onset of confirmed disability progression (CDP) events, confirmed over at least 24 weeks
Who it is for (from inclusion criteria)
Ages 18 Years to 60 Years
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
Absence of clinical relapses for at least 24 months
Who the registry excludes
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
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 NCT07299019?
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 NCT07299019?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.