Secondary Progressive Multiple SclerosisPhase 3NCT07299019
A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis
A Phase 3 study testing Orelabrutinib in people with Secondary Progressive Multiple Sclerosis, run by Zenas BioPharma (USA), LLC at 61 sites in 13 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 non-active Secondary Progress MS. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Secondary Progressive Multiple Sclerosis
- 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
- 990 participants
- Where
- 61 sitesin 13 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, at the time of signing the informed consent.
- Participant must have a previous diagnosis of RRMS in accordance with 2024 McDonald criteria
- Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013
- 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).
- Absence of clinical relapses for at least 24 months.
Who cannot join
- The patient has been diagnosed with primary progressive MS (PPMS) according to 2024 McDonald diagnostic criteria
- Immunologic disorder other than MS or any other conditions requiring corticosteroid therapy.
- History or current diagnosis of other neurological disorders that may mimic MS
- History or current diagnosis of progressive multifocal leukoencephalopathy
- Active, clinically significant viral, bacterial, or fungal infection
- History of any other significant active medical condition
Show all 13Show fewer
- History of suicidal behavior within 6 months prior to Screening
- Any prior history of malignancy
- Patients on anticoagulation, or antiplatelet therapy
- Patients took strong/moderate CYP3A inhibitors or strong/moderate CYP3A inducers within 14 days
- Clinically significant laboratory abnormalities at Screening.
- 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
61 sites in 13 countries. Contact the study team or a site near you to ask about taking part.
61 sites in 13 countries
United States26 sites, 25 recruiting
- Recruiting
University Of New Mexico School Of Medicine
Albuquerque, New Mexico, 87131
- Recruiting
SFM Clinical Research, LLC
Boca Raton, Florida, 33487
- Withdrawn
Boston Clinical Trials
Boston, Massachusetts, 02131
- Recruiting
Nova Clinical Research, LLC
Bradenton, Florida, 34209
- Recruiting
MS and Neuromuscular Center of Excellence
Clearwater, Florida, 33761
- 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
Fullerton Neurology and Headache Center
Fullerton, California, 92835
- Recruiting
Premier Neurology
Greenville, South Carolina, 29605
- Recruiting
Josephson Wallack Munshower Neurology, Pc Suite 225
Indianapolis, Indiana, 46256
- Recruiting
Neurology Associates
Maitland, Florida, 32751
- Recruiting
Aqualane Clinical Research
Naples, Florida, 34105
- Recruiting
Mount Sinai Medical Center
New York, New York, 10029
- Recruiting
OMRF Multiple Sclerosis Center of Excellence
Oklahoma City, Oklahoma, 73104
- Recruiting
Arizona Neuroscience Research, LLC
Phoenix, Arizona, 85032
- Recruiting
Profound Research LLC at Oakland Neurology Center
Rochester Hills, Michigan, 48307
- Recruiting
KC Research Center, PA Neurology Research Dept
Roeland Park, Kansas, 66205
- Recruiting
Lone Star Neurology
San Antonio, Texas, 78258
- Recruiting
Perseverance Research Center, LLC (PRC)
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
Harbor-UCLA Medical Center - The Lundquist Institute (Los Angeles Biomedical Research Institute (LA BioMed))
Torrance, California, 90502-2006
- Recruiting
Regina Berkovich MD, PhD Inc
West Hollywood, California, 90048
- Recruiting
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
Poland14 sites, 14 recruiting
- Recruiting
Centrum Medyczne INTERCOR Sp. z o.o.
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-605
- Recruiting
NZOZ Novo Med
Katowice, Silesian Voivodeship, 40-584
- Recruiting
MA-LEK Clinical Sp. z o.o.
Katowice, 40-571
- Recruiting
Neuro Medic Clinic
Katowice, 40-686
- Recruiting
PRO SALUS Sp. z o.o. sp.k.
Lodz, Łódź Voivodeship, 91-743
- Recruiting
Galen Clinic
Lublin, 20-064
- Recruiting
NZOZ Neuromed M. i M. Nastaj Sp.P
Lublin, 20-064
- Recruiting
Malva Trials
Lublin, 20-601
- Recruiting
Twoja Przychodnia Centrum Medyczne Nowa Sól
Nowa Sól, Lubusz Voivodeship, 67-100
- Recruiting
Twoja Przychodnia PCM
Poznan, Wielkopolska, 60-324
- Recruiting
Nzoz Neuro-Kard Ilkowski I Partnerzy Spolka Partnerska Lekarzy
Poznan, Wielkopolska, 61-853
- Recruiting
Prywatna Lecznica Certus Sp. z o.o.
Poznan, 15-540
- Recruiting
Nmedis sp. z o.o.
Rzeszów, Rzeszów, 35-323
- Recruiting
EUROMEDIS Osrodek Badan Klinicznych
Szczecin, 70-111
Ukraine4 sites, 4 recruiting
- 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, 79010
- Recruiting
Medical Clinical Investigational Center of Medical Center LLC Health Clinic
Vinnytsia, 21009
Bulgaria3 sites, 3 recruiting
- Recruiting
Medical Center Nevrocentrum
Plovdiv, Plovdiv, 4000
- Recruiting
Diagnostic and Consultative Center Convex
Sofia, Sofia, 1680
- Recruiting
Medical Center Medica Plus OOD
Veliko Tarnovo, 5000
Georgia3 sites, 3 recruiting
- Recruiting
MD Georgia Staff Physician MediClub Georgia
Tbilisi, Saburtalo, 0160
- Recruiting
NNLE Jo Ann University Hospital
Tbilisi, 0159
- Recruiting
Raymann, LLC
Tbilisi, 0186
Hungary3 sites, 3 recruiting
- Recruiting
National Institute of Clinical Neurosciences
Budapest, 1145
- Recruiting
Valeomed Kft.
Esztergom, Komarom-Esztergom Vamegye, 2500
- Recruiting
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Tatabánya, 2800
Serbia2 sites, 2 recruiting
- Recruiting
University Clinical Centre of Kragujevac
Kragujevac, 3400
- Recruiting
Clinic of Neurology - Clinical Center Nis
Niš, 18000
Croatia1 site, 1 recruiting
- Recruiting
Klinicki Bolnicki Centar Zagreb-Rebro
Zagreb, 10 000
Estonia1 site, 1 recruiting
- Recruiting
Astra clinic (Clinic4U)
Tallinn, Harju, 10617
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Neurologico Mediterraneo Neuromed
Pozzilli, Isernia/Molise, 86077
Lithuania1 site, 1 recruiting
- Recruiting
Hospital of Lithuanian University of Health Sciences
Kaunas, Kauno, 50161
Puerto Rico1 site, 1 recruiting
- Recruiting
Caribbean Center for Clinical Research
Guaynabo, 00969
About this study
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
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.
Read the detailed description
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 naSPMS. The study will enroll approximately 990 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.
The study consists of the following periods:
- Screening Period: Up to 4 weeks.
- Treatment Period: The duration of treatment will vary for individual participants ranging from approximately 24 to 60 months, depending on the time of recruitment. A month is defined as a period of 28 days by convention.
- Double-blinded (DB) Treatment: All eligible participants will be randomized at 2:1 ratio to accept orelabrutinib QD or placebo during the DB treatment period. The study will be unblinded when all participants in the DB period have reached a minimum treatment duration of 12 months at the time of primary analysis timing cutoff.
- Open-label (OL) Treatment: Participants with 24-week CDP as assessed by EDSS are eligible for 2-year open-label orelabrutinib treatment.
- Safety Follow-Up Period: It will last 4 weeks. The safety follow-up period will begin when the participants discontinue from the treatment before the end of the trial for any reasons or complete the trial but do not enter the long-term safety study (LTS) (see below).
All active study participants will have a final end of study (EOS) visit within 4 weeks of the study end date. Participants who are receiving IMP in DB or OL but do not consent to or are not eligible for enrollment in the LTS study, must return for a final safety follow-up visit 4 weeks later. For participants who intend and are eligible to join the LTS, open-label treatment with orelabrutinib will continue and no safety follow-up will occur.
- Conditions
- Secondary Progressive Multiple Sclerosis
- 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
Orelabrutinib orally
PlaceboDrug
Placebo orally
| Study group | Role | What they receive |
|---|---|---|
| Orelabrutinib Group | Experimental | Orelabrutinib PO daily Receives: Drug: Orelabrutinib |
| Placebo Group | Placebo comparator | Placebo PO daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to onset of confirmed disability progression (CDP) events, confirmed over at least 24 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
Measured: Up to approximately 120 weeks
Secondary outcomes (10)
12 Week CDP
Time to onset of CDP events on EDSS, confirmed over at least 12 weeks
Measured: Up to approximately 120 weeks
T2 lesions on MRI
The total number of new or enlarging T2 lesions on MRI scans of the brain
Measured: Up to approximately 120 weeks
24-week CDP-9-hole Peg Test
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
Measured: Up to approximately 120 weeks
24-week CDP-T25FWT
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
Measured: Up to approximately 120 weeks
24-week CDI
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
Measured: Up to approximately 120 weeks
24-week CDI-9HPT
Time to onset of CDI events 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-T25FWT
Time to onset of CDI events on T25FWT, defined as ≥ 20% decrease on the T25FWT score from baseline, confirmed over at least 24 weeks
Measured: Up to approximately 120 weeks
Symbol Digit Modalities Test
The change in cognitive function as assessed by Symbol Digit Modalities Test (SDMT) from baseline to each scheduled visit
Measured: Up to approximately 120 weeks
Annualized relapse rate
Annualized relapse rate (ARR) during the study period assessed by protocol-defined adjudicated relapses
Measured: Up to approximately 120 weeks
To evaluate the safety and tolerability of orelabrutinib
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);
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 posted23 Dec 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 Secondary Progressive Multiple SclerosisStudies 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
- 990 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
- NCT07299019
- Sponsor's protocol ID
- ZB020-03-002
- Status last verified
- Oct 2026
- First submitted
- 18 Dec 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 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 Non-active Secondary Progressive Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07299019
- Acronym / sponsor ID
- ZB020-03-002
- Conditions
- Secondary Progressive Multiple Sclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 990 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
- 23 Dec 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 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.
Detailed description
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 naSPMS. The study will enroll approximately 990 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.
The study consists of the following periods:
- Screening Period: Up to 4 weeks.
- Treatment Period: The duration of treatment will vary for individual participants ranging from approximately 24 to 60 months, depending on the time of recruitment. A month is defined as a period of 28 days by convention.
- Double-blinded (DB) Treatment: All eligible participants will be randomized at 2:1 ratio to accept orelabrutinib QD or placebo during the DB treatment period. The study will be unblinded when all participants in the DB period have reached a minimum treatment duration of 12 months at the time of primary analysis timing cutoff.
- Open-label (OL) Treatment: Participants with 24-week CDP as assessed by EDSS are eligible for 2-year open-label orelabrutinib treatment.
- Safety Follow-Up Period: It will last 4 weeks. The safety follow-up period will begin when the participants discontinue from the treatment before the end of the trial for any reasons or complete the trial but do not enter the long-term safety study (LTS) (see below).
All active study participants will have a final end of study (EOS) visit within 4 weeks of the study end date. Participants who are receiving IMP in DB or OL but do not consent to or are not eligible for enrollment in the LTS study, must return for a final safety follow-up visit 4 weeks later. For participants who intend and are eligible to join the LTS, open-label treatment with orelabrutinib will continue and no safety follow-up will occur.
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: OrelabrutinibOrelabrutinib PO daily |
| Placebo Group | Placebo comparator | Drug: PlaceboPlacebo PO daily |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18 to 60 years of age, inclusive, at the time of signing the informed consent.
- Participant must have a previous diagnosis of RRMS in accordance with 2024 McDonald criteria
- Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013
- 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).
- Absence of clinical relapses for at least 24 months.
Key exclusion criteria (13 listed)
- The patient has been diagnosed with primary progressive MS (PPMS) according to 2024 McDonald diagnostic criteria
- Immunologic disorder other than MS or any other conditions requiring corticosteroid therapy.
- History or current diagnosis of other neurological disorders that may mimic MS
- History or current diagnosis of progressive multifocal leukoencephalopathy
- Active, clinically significant viral, bacterial, or fungal infection
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 |
|---|---|---|
| OrelabrutinibOrelabrutinib orally | Drug | Orelabrutinib Group |
| PlaceboPlacebo orally | Drug | Placebo Group |
Primary outcome
Time to onset of confirmed disability progression (CDP) events, confirmed over at least 24 weeks
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
10 secondary outcomes
12 Week CDP
Time frame: Up to approximately 120 weeks
T2 lesions on MRI
Time frame: Up to approximately 120 weeks
24-week CDP-9-hole Peg Test
Time frame: Up to approximately 120 weeks
24-week CDP-T25FWT
Time frame: Up to approximately 120 weeks
24-week CDI
Time frame: Up to approximately 120 weeks
24-week CDI-9HPT
Time frame: Up to approximately 120 weeks
24-week CDI-T25FWT
Time frame: Up to approximately 120 weeks
Symbol Digit Modalities Test
Time frame: Up to approximately 120 weeks
Annualized relapse rate
Time frame: Up to approximately 120 weeks
To evaluate the safety and tolerability of orelabrutinib
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 21 Oct 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.
61 sites in 13 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 Secondary Progressive Multiple Sclerosis, run by Zenas BioPharma (USA), LLC at 61 sites in 13 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 5 inclusion and 13 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 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United States, Poland, Ukraine, Bulgaria, Georgia and 8 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 confirmed disability progression (CDP) events, confirmed over at least 24 weeks (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 21 Oct 2026.