Relapsing Multiple SclerosisPhase 2NCT06564311
A Study of Obexelimab in Patients With Relapsing Multiple Sclerosis (MoonStone)
A Phase 2 study testing Obexelimab in people with Relapsing Multiple Sclerosis, run by Zenas BioPharma (USA), LLC at 47 sites in 12 countries.
Trial summary
This study aims to examine the efficacy and safety of obexelimab in participants with relapsing multiple sclerosis Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Relapsing Multiple Sclerosis
- What is being tested?
- Obexelimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 47 sitesin 12 countries
- Study dates
- 26 Aug 2024to Feb 2026
- Phase
- Phase 2
- 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
- Diagnosis of RMS (relapsing-remitting or secondary progressive with relapses) according to the 2017 revision of the McDonald diagnostic criteria
- An EDSS of ≤ 5.5 at the Screening Visit
- Must have documentation of:
- . at least 1 relapse within the previous year OR
- . ≥ 2 relapses within the past 2 years OR
- . ≥ 1 active Gd-enhancing brain lesion on an MRI scan within the past 6 months prior to screening
- Not of childbearing potential or willing to follow contraceptive guidance
Who cannot join
- Primary progressive MS or secondary progressive MS without relapses
- Meet criteria for neuromyelitis optica spectrum disorder
- Relapse in the 30 days prior to randomization
- ≥ 10 years disease duration from onset with patient's EDSS ≤ 2.0 (patient reported is adequate in absence of written medical record)
- Has > 20 Gd+ lesions on brain MRI at screening
Trial locations and contacts
47 sites in 12 countries.
47 sites in 12 countries
United States14 sites
Boster Center for MS
Columbus, Ohio, 43235
North Central Neurology
Cullman, Alabama, 35058
Center for Neurological Disorders
Greenfield, Wisconsin, 53228
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Aqualine Clinical Research
Naples, Florida, 35105
Center for Neurology and Spine
Phoenix, Arizona, 85032
North Texas Institute of Neurology and Headache
Plano, Texas, 75024
Infusion Associates Plymouth
Plymouth, Minnesota, 55446
Perseverance Research Center
Scottsdale, Arizona, 85253
MS Center for Innovations in Care
St Louis, Missouri, 63131
University of South Florida
Tampa, Florida, 33620
Holy Name Medical Center
Teaneck, New Jersey, 07666
Regina Berkovich MD PhD, Inc
West Hollywood, California, 90048
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
Spain7 sites
Hospital Clinico San Carlos
Madrid
Hospital General Universitario Gregorio Marañon
Madrid
Hospital Regional Universitario de Malaga - Hospital General
Málaga
Hospital Regional Universitario de Malaga
Málaga
Hospital Universitario Virgen de La Arrixaca
Murcia
Hospital Virgen Macarena
Seville
Hospipal La Fe Valencia
Valencia
China5 sites
Tiantan Hospital, Capital Medical University
Beijing
The First Affiliation Hospital of Soochow University
Suzhou
Tianjin Medical University General Hospital
Tianjin
People's Hospital of Xinjiang Uyaur Autonomous Region
Ürümqi
Tongji Hospital, Tongji Medical Center of HUST
Wuhan
Italy4 sites
Fondazione Isituto G. Giglio di Cefalu
Cefalù
University of Florence
Florence
Istituto Neurologico Mediterraneo Neuromed
Pozzilli
Fondazione PTV Policlinico Tor Vergata
Roma
Poland4 sites
Neurocentrum Bydgoszcz sp.z o.o.
Bydgoszcz
M.A. LEK A.M. Maciejowsy Spolka Cywilna
Katowice
Zanamed Medical Clinic Sp z o.o.
Lublin
Wielospecjalistyczne Centrum Medyczne Ibismed
Zabrze
Czechia3 sites
Fakultni nemocnice u sv. Anny v Brne
Brno
Nemocnice Jihlava
Jihlava
General University Hospital Praha
Prague
United Kingdom3 sites
Leicester General Hospital
Leicester
Barts Health NHS Trust
London
Morriston Hospital
Swansea
Belgium2 sites
Rehabilitation & MS Center, Noorderhart Hospital
Overpelt
AZ Delta-Deltalaan 1
Roeselare
Greece2 sites
Attikon University General Hospital
Chaïdári
University General Hospital of Larissa
Larissa
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Obexelimab in Patients With Relapsing Multiple Sclerosis
This study aims to examine the efficacy and safety of obexelimab in participants with relapsing multiple sclerosis
Read the detailed description
The study consists of a Screening Period (Day -28 to Day -1), a 24-week treatment period (Part A and Part B), a 52 week open label extension and an expected 12-week Follow-up Period. Patients with Relapsing Multiple Sclerosis will be randomized in 2:1 ratio to obexelimab or placebo. Randomization will be stratified by Gd lesion status at screening (≥ 1 vs 0).
Part A is the 12-week Randomized Placebo-Controlled Period (RCP), during which obexelimab or placebo will be administered as weekly subcutaneous (SC) injections. Following Part A, all patients will enter the Part B, a 12-week Open-Label Period (OLP), during which all patients will receive obexelimab administered as weekly SC injections. After Part B, patients will enter Part C, a 52-week Open-Label Extension (OLE), after which they will return for an in-clinic Safety Follow-Up Visit 12 weeks after the completion of Part C (i.e. Week 88). If at this time, B cells have not returned to baseline or above the lower limit of normal (LLN), patients will be asked to return every 12 weeks until B cells return to baseline or above the LLN (at minimum). The maximum expected duration of the study is 92 weeks (Screening Period = 4 weeks, Parts A, B and C = 76 weeks, Follow-up Period = 12 weeks).
- Conditions
- Relapsing Multiple Sclerosis
- Being tested
- Obexelimab, Placebo
- Keywords
- Relapsing Multiple Sclerosis, RMS, MS, Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObexelimabDrug
Obexelimab is a monoclonal antibody that simultaneously binds CD19 and FcyRIIb, resulting in down regulation of B cell activity
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Obexelimab | Experimental | Obexelimab will be administered as a subcutaneous injection for 76 weeks Receives: Drug: Obexelimab |
| Placebo | Placebo comparator | Placebo will be administered as a subcutaneous injection for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative number of new GdE T1 hyperintense lesions
Cumulative number of new GdE T1 hyperintense lesions as measured by brain MRI
Measured: Week 8 and Week 12
Secondary outcomes (5)
Number of T2 Lesions
cumulative number of new and/or enlarging T2 weighted hyperintense lesions
Measured: Week 8 and Week 12
Number of GdE T1 lesions
number of new GdE T1 hyperintense lesions
Measured: Week 4, Week 8, and Week 12
Volume of T2 lesions
change from baseline in volume of T2 lesions
Measured: Week 12
Serum NfL
serum NfL
Measured: Week 12
Incidence of Adverse Events, injection site reactions and hypersensitivity reactions
Incidence of Adverse Events, injection site reactions and hypersensitivity reactions, serious adverse events, and adverse events of special interest, as defined by the CTCAE v5.0
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start26 Aug 2024
- Primary completion28 Aug 2025
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a Phase 2, multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of obexelimab in patients with RMS. The study consists of a Screening Period (Day 28 to Day -1), followed by a 24-week Treatment Period (Part A or RCP consists of 12 doses of obexelimab or placebo; Part B or OLP consists of 12 doses of open-label obexelimab), a 52-week OLE and an expected 12-week Follow-up Period.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 93 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
- NCT06564311
- Sponsor's protocol ID
- ZB012-02-002
- Status last verified
- Jun 2025
- First submitted
- 19 Aug 2024
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Obexelimab in Patients With Relapsing Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06564311
- Acronym / sponsor ID
- ZB012-02-002
- Conditions
- Relapsing Multiple Sclerosis
- Keywords
- Relapsing Multiple Sclerosis, RMS, MS, Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Zenas BioPharma (USA), LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 28 Aug 2025 (actual)
- Study completion
- Feb 2026 (estimated)
- First posted
- 21 Aug 2024 (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.
This study aims to examine the efficacy and safety of obexelimab in participants with relapsing multiple sclerosis
Detailed description
The study consists of a Screening Period (Day -28 to Day -1), a 24-week treatment period (Part A and Part B), a 52 week open label extension and an expected 12-week Follow-up Period. Patients with Relapsing Multiple Sclerosis will be randomized in 2:1 ratio to obexelimab or placebo. Randomization will be stratified by Gd lesion status at screening (≥ 1 vs 0).
Part A is the 12-week Randomized Placebo-Controlled Period (RCP), during which obexelimab or placebo will be administered as weekly subcutaneous (SC) injections. Following Part A, all patients will enter the Part B, a 12-week Open-Label Period (OLP), during which all patients will receive obexelimab administered as weekly SC injections. After Part B, patients will enter Part C, a 52-week Open-Label Extension (OLE), after which they will return for an in-clinic Safety Follow-Up Visit 12 weeks after the completion of Part C (i.e. Week 88). If at this time, B cells have not returned to baseline or above the lower limit of normal (LLN), patients will be asked to return every 12 weeks until B cells return to baseline or above the LLN (at minimum). The maximum expected duration of the study is 92 weeks (Screening Period = 4 weeks, Parts A, B and C = 76 weeks, Follow-up Period = 12 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a Phase 2, multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of obexelimab in patients with RMS. The study consists of a Screening Period (Day 28 to Day -1), followed by a 24-week Treatment Period (Part A or RCP consists of 12 doses of obexelimab or placebo; Part B or OLP consists of 12 doses of open-label obexelimab), a 52-week OLE and an expected 12-week Follow-up Period.
| Arm | Type | Receives |
|---|---|---|
| Obexelimab | Experimental | Drug: ObexelimabObexelimab will be administered as a subcutaneous injection for 76 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be administered as a subcutaneous injection for 12 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Diagnosis of RMS (relapsing-remitting or secondary progressive with relapses) according to the 2017 revision of the McDonald diagnostic criteria
- An EDSS of ≤ 5.5 at the Screening Visit
- Must have documentation of:
- Not of childbearing potential or willing to follow contraceptive guidance
Key exclusion criteria (5 listed)
- Primary progressive MS or secondary progressive MS without relapses
- Meet criteria for neuromyelitis optica spectrum disorder
- Relapse in the 30 days prior to randomization
- ≥ 10 years disease duration from onset with patient's EDSS ≤ 2.0 (patient reported is adequate in absence of written medical record)
- Has > 20 Gd+ lesions on brain MRI at 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 |
|---|---|---|
| ObexelimabObexelimab is a monoclonal antibody that simultaneously binds CD19 and FcyRIIb, resulting in down regulation of B cell activity | Drug | Obexelimab |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Cumulative number of new GdE T1 hyperintense lesions
Time frame: Week 8 and Week 12
Cumulative number of new GdE T1 hyperintense lesions as measured by brain MRI
5 secondary outcomes
Number of T2 Lesions
Time frame: Week 8 and Week 12
Number of GdE T1 lesions
Time frame: Week 4, Week 8, and Week 12
Volume of T2 lesions
Time frame: Week 12
Serum NfL
Time frame: Week 12
Incidence of Adverse Events, injection site reactions and hypersensitivity reactions
Time frame: 24 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 17 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
47 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Obexelimab in people with Relapsing Multiple Sclerosis, run by Zenas BioPharma (USA), LLC at 47 sites in 12 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 7 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, Spain, China, Italy, Poland and 7 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative number of new GdE T1 hyperintense lesions (time frame: Week 8 and Week 12). 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 17 Nov 2025.