Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis

NCT07067463

RecruitingPhase 3

Sponsor: Zenas BioPharma (USA), LLC

Conditions: Multiple Sclerosis (MS) Primary Progressive

Interventions: Orelabrutinib, Placebo

Countries: United States, Bulgaria, Croatia, Czechia, Estonia, Germany, Italy, Netherlands

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 overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (34)
  • Pheonix, Arizona, United States
  • Scottsdale, Arizona, United States
  • West Hollywood, California, United States
  • Bradenton, Florida, United States
  • Maitland, Florida, United States
  • Roeland Park, Kansas, United States
  • St Louis, Missouri, United States
  • Livingston, New Jersey, United States
  • Raleigh, North Carolina, United States
  • Columbus, Ohio, United States
  • Greenville, South Carolina, United States
  • Cordova, Tennessee, United States
  • San Antonio, Texas, United States
  • Sherman, Texas, United States
  • Plovdiv, Plovdiv, Bulgaria
  • Sofia, Sofia, Bulgaria
  • Pleven, Bulgaria
  • Zagreb, Croatia
  • Choceň, Czechia
  • Tallinn, Harju, Estonia
  • Erbach im Odenwald, Hesse, Germany
  • Pozzilli, Isemiaa/Molise, Italy
  • Sittard, Limburg, Netherlands
  • Katowice, Silesian Voivodeship, Poland
  • Poznan, Wielkopolska, Poland
  • Poznan, Wielkopolska, Poland
  • Lublin, Poland
  • Lublin, Poland
  • Nowa Sól, Poland
  • Rzeszów, Poland
  • + 4 more on CT.gov