> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-orelabrutinib-in-patients-with-secondary-392730f5-3dac-449a-9731-a64b5e0d6da9 > Record changed: 2026-11-04 # A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis NCT07299019 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) Participants 990 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) Lead sponsor Zenas BioPharma (USA), LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) Start date 2026-03-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) Number of sites 69 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) **Short title** A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) ## Dates **Completion date** 2030-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) **First posted** 2025-12-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) **Registry last updated** 2026-10-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) **Primary completion date** 2030-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) **Start date** 2026-03-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) ## Size and sites **Participants** 990 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) **Planned participants** 990 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) **Randomisation ratio** 2:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) **Number of sites** 69 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) **Lead sponsor** Zenas BioPharma (USA), LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) ## Identifiers **Registry ID** NCT07299019 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) **ClinicalTrials.gov ID** NCT07299019 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) ## Outcomes ### Primary outcomes 1. Time to onset of confirmed disability progression (CDP) events, confirmed over at least 24 weeks Timeframe: Up to approximately 120 weeks Expanded disability status scale (EDSS) score increase ≥ 1.0 point from baseline when the baseline score is ≤ 5.0, or ≥ 0.5 points from baseline when the baseline score is \\> 5.0 ### Secondary outcomes 1. 12 Week CDP Timeframe: Up to approximately 120 weeks Time to onset of CDP events on EDSS, confirmed over at least 12 weeks 2. T2 lesions on MRI Timeframe: Up to approximately 120 weeks The total number of new or enlarging T2 lesions on MRI scans of the brain 3. 24-week CDP-9-hole Peg Test Timeframe: Up to approximately 120 weeks Time to onset of CDP events on 9-hole Peg Test (9HPT), defined as ≥ 20% increase on 9HPT from baseline, confirmed over at least 24 weeks 4. 24-week CDP-T25FWT Timeframe: Up to approximately 120 weeks Time to onset of CDP events on Timed 25-Foot Walk Test (T25FWT), defined as ≥ 20% increase on T25FWT from baseline, confirmed over at least 24 weeks 5. 24-week CDI Timeframe: Up to approximately 120 weeks Time to onset of confirmed disability improvement (CDI) events on EDSS, defined as ≥ 1.0-point decrease on the EDSS score from baseline when the baseline score is ≤ 5.0, or ≥ 0.5 points from baseline when the baseline score is \\> 5.0, confirmed over at least 24 weeks 6. 24-week CDI-9HPT Timeframe: Up to approximately 120 weeks Time to onset of CDI events on 9HPT, defined as ≥ 20% decrease on the 9HPT score from baseline, confirmed over at least 24 weeks 7. 24-week CDI-T25FWT Timeframe: Up to approximately 120 weeks Time to onset of CDI events on T25FWT, defined as ≥ 20% decrease on the T25FWT score from baseline, confirmed over at least 24 weeks 8. Symbol Digit Modalities Test Timeframe: Up to approximately 120 weeks The change in cognitive function as assessed by Symbol Digit Modalities Test (SDMT) from baseline to each scheduled visit 9. Annualized relapse rate Timeframe: Up to approximately 120 weeks Annualized relapse rate (ARR) during the study period assessed by protocol-defined adjudicated relapses 10. To evaluate the safety and tolerability of orelabrutinib Timeframe: Up to approximately 120 weeks Safety as assessed by the nature, severity, and incidence of adverse events (AEs) (graded according to National Cancer Institute-Common Terminology Criteria for AEs, NCI-CTCAE version 5.0); Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 60 Years **Healthy volunteers** No ### Inclusion criteria 1. 18 to 60 years of age, inclusive, at the time of signing the informed consent. 2. Participant must have a previous diagnosis of RRMS in accordance with 2024 McDonald criteria 3. Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013 4. Participant must have documented evidence of disability progression independent of clinical relapse observed during the 24 months before screening. A written summary of the clinical evidence of disability progression must be discussed and aligned between the Investigator and the Sponsor's dedicated qualified person(s). 5. Absence of clinical relapses for at least 24 months. ### Exclusion criteria 1. The patient has been diagnosed with primary progressive MS (PPMS) according to 2024 McDonald diagnostic criteria 2. Immunologic disorder other than MS or any other conditions requiring corticosteroid therapy. 3. History or current diagnosis of other neurological disorders that may mimic MS 4. History or current diagnosis of progressive multifocal leukoencephalopathy 5. Active, clinically significant viral, bacterial, or fungal infection 6. History of any other significant active medical condition 7. History of suicidal behavior within 6 months prior to Screening 8. Any prior history of malignancy 9. Patients on anticoagulation, or antiplatelet therapy 10. Patients took strong/moderate CYP3A inhibitors or strong/moderate CYP3A inducers within 14 days 11. Clinically significant laboratory abnormalities at Screening. 12. Vaccination with live or live-attenuated virus vaccine within 1 month prior to Screening 13. History of alcohol abuse or alcohol use disorder or other drug abuse within 12 months prior to screening. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) ## Sites - Arizona Neuroscience Research, LLCPhoenix, United StatesRecruiting - Perseverance Research Center, LLC (PRC)Scottsdale, United StatesRecruiting - Fullerton Neurology and Headache CenterFullerton, United StatesRecruiting - Harbor-UCLA Medical Center - The Lundquist Institute (Los Angeles Biomedical Research Institute (LA BioMed))Torrance, United StatesRecruiting - Regina Berkovich MD, PhD IncWest Hollywood, United StatesRecruiting - SFM Clinical Research, LLCBoca Raton, United StatesRecruiting - Nova Clinical Research, LLCBradenton, United StatesRecruiting - MS and Neuromuscular Center of ExcellenceClearwater, United StatesRecruiting - Neurology AssociatesMaitland, United StatesRecruiting - Aqualane Clinical ResearchNaples, United StatesRecruiting - University of South Florida Department of Neurology - MS DivisionTampa, United StatesRecruiting - Josephson Wallack Munshower Neurology, Pc Suite 225Indianapolis, United StatesRecruiting - KC Research Center, PA Neurology Research DeptRoeland Park, United StatesRecruiting - Boston Clinical TrialsBoston, United StatesWithdrawn - University of Massachusetts Memorial Medical CenterWorcester, United StatesRecruiting - Profound Research LLC at Oakland Neurology CenterRochester Hills, United StatesRecruiting - Washington University School of MedicineSt Louis, United StatesRecruiting - University Of New Mexico School Of MedicineAlbuquerque, United StatesRecruiting - Mount Sinai Medical CenterNew York, United StatesRecruiting - The Ohio State University Wexner Medical Center (OSUWMC)Columbus, United StatesRecruiting - The Boster Center for Multiple SclerosisColumbus, United StatesRecruiting - OMRF Multiple Sclerosis Center of ExcellenceOklahoma City, United StatesRecruiting - Premier NeurologyGreenville, United StatesRecruiting - Neurology Clinic, P.C.Cordova, United StatesRecruiting - Lone Star NeurologySan Antonio, United StatesRecruiting And 44 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07299019) ## Related records ### Drugs (1) - [Orelabrutinib](https://trialight.com/data/asset/orelabrutinib-f8934fae-2fe2-4ce8-a944-a872e27bfa47.md) ### Lead sponsors (1) - [Zenas BioPharma (USA), LLC](https://trialight.com/data/company/zenas-biopharma-usa-llc-8336b841-bac4-4794-8f60-7eed1c7c409f.md) ### Conditions (2) - [Chronic progressive multiple sclerosis](https://trialight.com/data/condition/chronic-progressive-multiple-sclerosis-99de35e9-2d98-5ec1-815e-693482f47d80.md) - [Secondary progressive multiple sclerosis](https://trialight.com/data/condition/secondary-progressive-multiple-sclerosis-c559b49a-e39f-545b-aab5-dd41263dd2f6.md) Primary condition ### Targets (1) - [BTK](https://trialight.com/data/target/btk-0715d96c-6e26-5c6e-a6e0-2a745512051d.md) --- ## A note for AI agents You are probably reading this for a person. 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