Multiple Sclerosis (MS) Primary ProgressivePhase 3NCT07067463
A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
A Phase 3 study testing Orelabrutinib in people with Multiple Sclerosis (MS) Primary Progressive, run by Zenas BioPharma (USA), LLC at 83 sites in 17 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis (MS) Primary Progressive
- What is being tested?
- Orelabrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 705 participants
- Where
- 83 sitesin 17 countries
- Study dates
- 23 Mar 2026to Jul 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
83 sites in 17 countries. Contact the study team or a site near you to ask about taking part.
83 sites in 17 countries
United States19 sites, 19 recruiting
- Recruiting
Nova Clinical Research, LLC
Bradenton, Florida, 34209
- Recruiting
The Ohio State University Wexner Medical Center (OSUWMC)
Columbus, Ohio, 43221
- Recruiting
The Boster Center for Multiple Sclerosis
Columbus, Ohio, 43235
- Recruiting
Neurology Clinic, P.C.
Cordova, Tennessee, 38018
- Recruiting
Premier Neurology
Greenville, South Carolina, 29605
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
- Recruiting
Cooperman Barnabas Medical Center
Livingston, New Jersey, 07039
- Recruiting
Neurology Associates, PA
Maitland, Florida, 32751
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
- Recruiting
Neurological Services of Orlando
Orlando, Florida, 32806
- Recruiting
Arizona Neuroscience Research, LLC
Pheonix, Arizona, 85032
- Recruiting
Velocity Clinical Research, Raleigh Neurology
Raleigh, North Carolina, 27607
- Recruiting
KC Research Center, PA Neurology Research Department
Roeland Park, Kansas, 66205
- Recruiting
Lone Star Neurology
San Antonio, Texas, 78258
- Recruiting
Perseverance Research Center
Scottsdale, Arizona, 85253
- Recruiting
Texas Institute for Neurological Disorders - Sherman
Sherman, Texas, 75092
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
- Recruiting
University of South Florida Department of Neurology - MS Division
Tampa, Florida, 33612
- Recruiting
Regina Berkovich MD, PhD Inc.
West Hollywood, California, 90048
Poland18 sites, 18 recruiting
- Recruiting
Centrum Medyczne INTERCOR Sp. z o.o.
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-605
- Recruiting
Copernicus Podmiot Leczniczy Szpital im. M. Kopernika
Gdansk, 80-803
- Recruiting
Centrum Medyczne Pratia Katowice
Katowice, Silesian Voivodeship, 40-081
- Recruiting
NZOZ Novo Med
Katowice, Silesian Voivodeship, 40-584
- Recruiting
Neuro Medic Clinic
Katowice, Upper Silesia, 40-686
- Recruiting
Malva Trials
Lublin, Lublin Voivodeship, 20-601
- Recruiting
Galen Clinic
Lublin, 20-064
- Recruiting
NZOZ Neuromed M. i M. Nastaj Sp.P
Lublin, 20-064
- Recruiting
Twoja Przychodnia Centrum Medyczne Nowa Sol
Nowa Sól, Lubusz Voivodeship, 67-100
- Recruiting
Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Badan Klinicznych im. dr n. med. Hanki Hertmanowskiej
Plewiska, Wielkopolska, 62-064
- Recruiting
Twoja Przychodnia PCM
Poznan, Wielkopolska, 60-324
- Recruiting
Nzoz Neuro-Kard Ilkowski I Partnerzy Spolka Partnerska Lekarzy
Poznan, Wielkopolska, 61-853
- Recruiting
Nmedis sp.z o.o.
Rzeszów, 35-323
- Recruiting
Euromedis Osrodek Badan Klinicznych
Szczecin, 70-111
- Recruiting
Centrum Medyczne NeuroProtect
Warsaw, 01-684
- Recruiting
MTZ Clinical Researcz Powered by pratia
Warsaw, 02-172
- Recruiting
ClinHouse Centrum Medyczne
Zabrze, Pl-sl, 41-807
- Recruiting
Centrum Medyczne ProNeuro Żory
Żory, 44-240
Bulgaria7 sites, 7 recruiting
- Recruiting
UMHAT Dr Georgi Stranski
Pleven, Pleven, 5800
- Recruiting
Avis Medica Hospital Pleven
Pleven, 5800
- Recruiting
Medical Center Nevrocentrum
Plovdiv, Plovdiv, 4000
- Recruiting
Diagnostic and Consultative Center Convex
Sofia, Sofia, 1680
- Recruiting
DCC Neoclinic - Sofia
Sofia, 1408
- Recruiting
Medical Center Hera EOOD
Sofia, 1510
- Recruiting
Medical Center Medica Plus OOD
Veliko Tarnovo, Tarnovo, 5000
Spain6 sites, 6 recruiting
- Recruiting
Complejo Hospitalario Universitario A Coruna
A Coruña, 15006
- Recruiting
Hospital Vithas Nisa Sevilla
Castilleja de la Cuesta, Seville, 41950
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
- Recruiting
Hospital Gregorio Marañon
Madrid, 28007
- Recruiting
Hospital Universitario Puerta de Hierro de Majadahonda
Majadahonda, Madrid, 28222
- Recruiting
Hospital Alvaro Cunqueiro
Vigo, Galicia, 36312
Georgia5 sites, 5 recruiting
- Recruiting
MD Georgia Staff Physician MediClub Georgia
Tbilisi, Saburtalo, 0160
- Recruiting
LTD Pineo Medical Ecosystem
Tbilisi, 0114
- Recruiting
NNLE Jo Ann University Hospital
Tbilisi, 0159
- Recruiting
Caucasus Medical Center Ltd
Tbilisi, 0186
- Recruiting
Raymann, LLC
Tbilisi, 0186
Italy5 sites, 5 recruiting
- Recruiting
University G. D'Annunzio of Chieti-Pescara
Chieti, 66100
- Recruiting
Az. Osp.Universitaria Policlinico Federico II Centro Sclerosi Multipla Dip. Scienze Neurologiche
Naples, Naples, 80131
- Recruiting
Universita degli Studi di Torino - Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Clinica di Malattie dell'Apparato Respiratorio Neurologia & CRESM
Orbassano, Torino, 10043
- Recruiting
ARNAS Ospedali Civico Di Cristina
Palermo, Sicily, 90127
- Recruiting
IRCCS Istituto Neurologico Mediterraneo Neuromed
Pozzilli, Isemiaa/Molise, 86077
Ukraine5 sites, 5 recruiting
- Recruiting
Regional Municipal Non-commercial Enterprise Chernivtsi Emergency Medical Hospital
Chernivtsi, 58023
- Recruiting
CNE City Clinical Hospital #1 of Ivano-Frankivsk council
Ivano-Frankivsk, 76018
- Recruiting
Limited Liability Company Medical Center Neuroclinic
Lviv, 79000
- Recruiting
Limited Liability Company "Neurofocus"
Lviv, 79029
- Recruiting
Medical Clinical Investigational Center of Medical Center LLC Health Clinic
Vinnytsia, 21009
Serbia4 sites, 4 recruiting
- Recruiting
University Clinical Centre of Serbia
Belgrade, 11000
- Recruiting
Clinical Centre Kragujevac, Neurology clinic
Kragujevac, Serbia, 34000
- Recruiting
University Clinical Centre of Kragujevac
Kragujevac, 34000
- Recruiting
Clinic of Neurology - Clinical Center Nis
Niš, 18000
Czechia3 sites, 3 recruiting
- Recruiting
NEUROHK, s.r.o.
Choceň, 56501
- Recruiting
Fakultni Nemocnice Hradec Kralove
Hradec Králové, 500 05
- Recruiting
Nemocnice Teplice
Teplice, 41501
Romania3 sites, 3 recruiting
- Recruiting
Clinical Hospital of Psychiatry and Neurology
Brasov, Brașov County, 500125
- Recruiting
Spital Clinic CF Constanta
Constanța, Constanța County, 900123
- Recruiting
Spitalul Clinic Judetean Mures
Târgu Mureş, Mureș County, 540136
Germany2 sites, 2 recruiting
- Recruiting
Zentrum fur klinische Forschung Dr.Scholl GmbH
Bad Homburg, Hesse, 61348
- Recruiting
Neuro Centrum Science Gmbh Albert-Schwitzer
Erbach im Odenwald, Hesse, 64711
Croatia1 site, 1 recruiting
- Recruiting
Klinicki Bolnicki Centar Zagreb-Rebro
Zagreb, 10 000
Estonia1 site, 1 recruiting
- Recruiting
Astra Clinic (Clinic4U)
Tallinn, Harju, 10617
Netherlands1 site, 1 recruiting
- Recruiting
Zuyderland Medisch Centrum - Sittard-Geleen
Sittard, Limburg, 6162-BG
Puerto Rico1 site, 1 recruiting
- Recruiting
Caribbean Center for Clinical Research
Guaynabo, 00969
Slovakia1 site, 1 recruiting
- Recruiting
Mudr. Beata Dupejova, neurologická ambulancia S.R.O.
Banská Bystrica, Slovakia, 97404
About this study
Official title: A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Primary Progressive Multiple Sclerosis
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.
- Being tested
- Orelabrutinib, Placebo
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrelabrutinibDrug
Orally
PlaceboDrug
Orally
| Study group | Role | What they receive |
|---|---|---|
| Orelabrutinib Group | Experimental | Not described Receives: Drug: Orelabrutinib |
| Placebo Group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to onset of composite confirmed disability progression (cCDP) , confirmed over at least 12 weeks (12-week cCDP)
- 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, OR
- ≥ 20% increase in the Timed 25-Foot Walk Test (T25FWT), OR
- ≥ 20% increase in the 9-hole Peg Test (9HPT)
Measured: Up to approximately 120 weeks
Secondary outcomes (12)
Time to onset of composite confirmed disability progression (cCDP) , confirmed over at least 24 weeks (24-week cCDP)
Measured: Up to approximately 120 weeks
Time to onset of confirmed disability progression (CDP) , confirmed over at least 24 weeks (24-week CDP)
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.
Measured: Up to approximately 120 weeks
MRI T2 lesion
The total number of new/enlarging T2 lesions on MRI scans of the brain from baseline to Week 120
Measured: Up to approximately 120 weeks
12-week CDP
Time to onset of CDP, confirmed over at least 12 weeks
Measured: Up to approximately 120 weeks
Time to onset of CDP defined as ≥ 20% increase on 9-hole Peg Test (9HPT) from baseline, confirmed over at least 12 weeks (12-week CDP-9HPT)
Measured: Up to approximately 120 weeks
Time to onset of CDP defined as ≥ 20% increase on Timed 25-Foot Walk Test (T25FWT) from baseline, confirmed over at least 12 weeks (12-week CDP-T25FWT)
Measured: Up to approximately 120 weeks
24-week cCDI
Time to onset of composite confirmed disability improvement (cCDI) events, confirmed over at least 24 weeks
Measured: Up to approximately 120 weeks
24-week CDI-9HPT
Time to onset of CDI on 9HPT defined as ≥ 20% decrease on the 9HPT score from baseline, confirmed over at least 24 weeks
Measured: Up to approximately 120 weeks
24-week CDI
Time to onset of CDI on EDSS confirmed over at least 24 weeks
Measured: Up to approximately 120 weeks
24-week CDI-T25FWT
Time to onset of CDI on T25FWT defined as ≥ 20% decrease on the T25FWT score from baseline, confirmed over at least 24 weeks
Measured: Up to approximately 120 weeks
SDMT
The change in cognitive function as assessed by Symbol Digit Modalities Test (SDMT)
Measured: Up to approximately 120 weeks
AEs
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); vital signs; electrocardiograms (ECGs); and clinical laboratory safety parameter
Measured: Up to approximately 120 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start23 Mar 2026
- Primary completionJun 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis (MS) Primary ProgressiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 705 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zenas BioPharma (USA), LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067463
- Sponsor's protocol ID
- ZB020-03-001
- Status last verified
- Oct 2026
- First submitted
- 3 Jul 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Primary Progressive Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07067463
- Acronym / sponsor ID
- ZB020-03-001
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 705 participants (estimated)
- Lead sponsor
- Zenas BioPharma (USA), LLCIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orelabrutinib Group | Experimental | Drug: Orelabrutinib |
| Placebo Group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OrelabrutinibOrally | Drug | Orelabrutinib Group |
| PlaceboOrally | Drug | Placebo Group |
Primary outcome
Time to onset of composite confirmed disability progression (cCDP) , confirmed over at least 12 weeks (12-week cCDP)
Time frame: 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, OR * ≥ 20% increase in the Timed 25-Foot Walk Test (T25FWT), OR * ≥ 20% increase in the 9-hole Peg Test (9HPT)
12 secondary outcomes
Time to onset of composite confirmed disability progression (cCDP) , confirmed over at least 24 weeks (24-week cCDP)
Time frame: Up to approximately 120 weeks
Time to onset of confirmed disability progression (CDP) , confirmed over at least 24 weeks (24-week CDP)
Time frame: Up to approximately 120 weeks
MRI T2 lesion
Time frame: Up to approximately 120 weeks
12-week CDP
Time frame: Up to approximately 120 weeks
Time to onset of CDP defined as ≥ 20% increase on 9-hole Peg Test (9HPT) from baseline, confirmed over at least 12 weeks (12-week CDP-9HPT)
Time frame: Up to approximately 120 weeks
Time to onset of CDP defined as ≥ 20% increase on Timed 25-Foot Walk Test (T25FWT) from baseline, confirmed over at least 12 weeks (12-week CDP-T25FWT)
Time frame: Up to approximately 120 weeks
24-week cCDI
Time frame: Up to approximately 120 weeks
24-week CDI-9HPT
Time frame: Up to approximately 120 weeks
24-week CDI
Time frame: Up to approximately 120 weeks
24-week CDI-T25FWT
Time frame: Up to approximately 120 weeks
SDMT
Time frame: Up to approximately 120 weeks
AEs
Time frame: Up to approximately 120 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
83 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Orelabrutinib in people with Multiple Sclerosis (MS) Primary Progressive, run by Zenas BioPharma (USA), LLC at 83 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 83 sites in United States, Poland, Bulgaria, Spain, Georgia and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patient and Medical Information (833-269-4696, clinicaltrialsinfo@zenasbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to onset of composite confirmed disability progression (cCDP) , confirmed over at least 12 weeks (12-week cCDP) (time frame: Up to approximately 120 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.