A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis

Summary

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.

Eligibility

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.

Conditions2

Interventions1

Locations11 sites

Find trials near these locations

Related trials

• A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL — InnoCare Pharma Inc.
• A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma — Guangzhou Lupeng Pharmaceutical Company LTD.
• Application of Orelabrutinib With or Without CD20 Monoclonal Antibody in Previously Untreated Marginal Zone Lymphoma — Beijing Tongren Hospital
• Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment — Ruijin Hospital
• Efficacy and Safety of Orelabrutinib Combined With Rituximab Versus Lenalidomide Combined With Rituximab in Patients With Relapsed/Refractory Marginal Zone Lymphoma — Beijing InnoCare Pharma Tech Co., Ltd.
• Exploratory Study of Orelabrutinib in the Treatment of Early-stage Untreated MZL — Institute of Hematology & Blood Diseases Hospital, China
• Genetic Subtype-matched Targeted Therapy for the Treatment of Newly Diagnosed DLBCL With TP53 Mutation — The First Affiliated Hospital of Soochow University
• Genotype-guided Treatment in DLBCL — Ruijin Hospital

Browse More Trials