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RECRUITING
NCT07299019
PHASE3

A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis

Sponsor: Zenas BioPharma (USA), LLC

View on ClinicalTrials.gov

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 non-active Secondary Progress MS. Patients will be treated for approximately 24 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 990 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.

Official title: A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Non-active Secondary Progressive Multiple Sclerosis

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

990

Start Date

2026-03-23

Completion Date

2030-07

Last Updated

2026-08-25

Healthy Volunteers

No

Interventions

DRUG

Orelabrutinib

Orelabrutinib orally

DRUG

Placebo

Placebo orally

Locations (37)

Arizona Neuroscience Research, LLC

Phoenix, Arizona, United States

Perseverance Research Center, LLC (PRC)

Scottsdale, Arizona, United States

Fullerton Neurology and Headache Center

Fullerton, California, United States

Harbor-UCLA Medical Center - The Lundquist Institute (Los Angeles Biomedical Research Institute (LA BioMed))

Torrance, California, United States

Regina Berkovich MD, PhD Inc

West Hollywood, California, United States

SFM Clinical Research, LLC

Boca Raton, Florida, United States

Nova Clinical Research, LLC

Bradenton, Florida, United States

MS and Neuromuscular Center of Excellence

Clearwater, Florida, United States

Neurology Associates

Maitland, Florida, United States

Aqualane Clinical Research

Naples, Florida, United States

Josephson Wallack Munshower Neurology, Pc Suite 225

Indianapolis, Indiana, United States

KC Research Center, PA Neurology Research Dept

Roeland Park, Kansas, United States

Boston Clinical Trials

Boston, Massachusetts, United States

Profound Research LLC at Oakland Neurology Center

Rochester Hills, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

The Boster Center for Multiple Sclerosis

Columbus, Ohio, United States

OMRF Multiple Sclerosis Center of Excellence

Oklahoma City, Oklahoma, United States

Premier Neurology

Greenville, South Carolina, United States

Neurology Clinic, P.C.

Cordova, Tennessee, United States

Lone Star Neurology

San Antonio, Texas, United States

Texas Institute for Neurological Disorders - Sherman

Sherman, Texas, United States

Klinicki Bolnicki Centar Zagreb-Rebro

Zagreb, Croatia

NEUROHK, s.r.o.

Choceň, Czechia

Astra clinic (Clinic4U)

Tallinn, Harju, Estonia

Hospital of Lithuanian University of Health Sciences

Kaunas, Kauno, Lithuania

Centrum Medyczne INTERCOR Sp. z o.o.

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Twoja Przychodnia Centrum Medyczne Nowa Sól

Nowa Sól, Lubusz Voivodeship, Poland

Nmedis sp. z o.o.

Rzeszów, Rzeszów, Poland

NZOZ Novo Med

Katowice, Silesian Voivodeship, Poland

Twoja Przychodnia PCM

Poznan, Wielkopolska, Poland

Nzoz Neuro-Kard Ilkowski I Partnerzy Spolka Partnerska Lekarzy

Poznan, Wielkopolska, Poland

MA-LEK Clinical Sp. z o.o.

Katowice, Poland

Galen Clinic

Lublin, Poland

Malva Trials

Lublin, Poland

EUROMEDIS Osrodek Badan Klinicznych

Szczecin, Poland

PRO SALUS Sp. z o.o. sp.k.

Lodz, Łódź Voivodeship, Poland

University Clinical Centre of Kragujevac

Kragujevac, Serbia