Systemic Lupus ErythematosusPhase 2SunStoneNCT06559163
A Study of Obexelimab in Patients With Systemic Lupus Erythematosus
A Phase 2 study testing Obexelimab in people with Systemic Lupus Erythematosus, run by Zenas BioPharma (USA), LLC at 110 sites in 18 countries.
Trial summary
This study aims to examine the efficacy and safety of obexelimab in participants with systemic lupus erythematosus (SLE). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- 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
- 190 participants
- Where
- 110 sitesin 18 countries
- Study dates
- 17 Sep 2024to Dec 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, ≥ 18 to ≤ 70 years of age
- Diagnosed with SLE at least 24 weeks prior to screening and meets the 2019 EULAR/ACR classification criteria.
- Patient has all 3 of the following based on features active on the day of the visits:
- hSLEDAI ≥ 6 and clinical hSLEDAI ≥ 4 at screening, and clinical hSLEDAI ≥ 4 at Day 1 Note: Clinical points exclude laboratory tests, except proteinuria.
- BILAG-2004 Grade A or B in ≥ 1 organ system at screening and Day 1.
- In the opinion of the investigator and the central adjudicator, there is sufficient disease activity to warrant enrollment into a clinical study with an investigational agent.
- Patients must be treated with one or more of the following background nonbiologic lupus standard of care therapies: oral corticosteroid, antimalarial, and/or immunosuppressant.
Who cannot join
- Active lupus nephritis for which, in the opinion of the investigator or the central adjudicator, current medications are insufficient for patient's safety or additional therapy that is not permitted in the protocol is needed.
- A history of thrombosis or embolism in the previous 6 months before the Screening visit, or previous 12 months associated with antiphospholipid syndrome (APS) or another relevant hypercoagulable state.
- Any active skin conditions other than cutaneous lupus erythematosus (CLE) that may interfere with the study assessment of CLE such as, but not limited to, psoriasis, dermatomyositis, and systemic sclerosis.
- Active severe neuropsychiatric or central nervous system SLE.
- Current inflammatory disease other than SLE (including, but not limited to, rheumatoid arthritis, psoriatic arthritis, spondyloarthropathy, reactive arthritis, scleroderma, dermatomyositis) that may interfere with the assessment of lupus signs and symptoms in the opinion of the investigator or central adjudicator.
Trial locations and contacts
110 sites in 18 countries.
110 sites in 18 countries
United States32 sites
Emory University
Atlanta, Georgia, 30322
Axon Clinical Research
Baltimore, Maryland, 21237
DJL Clinical Research PLLC
Charlotte, North Carolina, 28211
AARA Clinical Research - Chicago Arthritis & Regenerative Medicine
Chicago, Illinois, 60661
Clinical Research of West Florida, Inc
Clearwater, Florida, 33765
Henry Ford Hospital
Detroit, Michigan, 48202
Cross Creek Medical Clinic
Fayetteville, North Carolina, 28304
Sierra Pacific Arthritis and Rheumatology Centers
Fresno, California, 93710
Penn State - Hershey Medical Center
Hershey, Pennsylvania, 17033
Prolato Clinical Research Center (PCRC)
Houston, Texas, 77054
Accurate Clinical Research
Houston, Texas, 77089
California Research Institute
Huntington Park, California, 90255
University of California, San Diego
La Jolla, California, 92037
Accurate Clinical Research
Lake Charles, Louisiana, 70605
Juno DO, PC
Lansing, Michigan, 48911
Prime Clinical Research - Lewisville
Lewisville, Texas, 75067
University of California, Los Angeles
Los Angeles, California, 90024
Prime Clinical Research - Mansfield
Mansfield, Texas, 76063
Yale University
New Haven, Connecticut, 06520
Hospital for Special Surgery
New York, New York, 10021
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104-5005
Onyx Clinical Research
Peoria, Arizona, 85381
Orthoillinois
Rockford, Illinois, 61114
Onsite Clinical Solutions
Salisbury, North Carolina, 28144
Velocity Clinical Research
St Louis, Missouri, 63131
Revive Research Institute - Sterling Heights
Sterling Heights, Michigan, 48313
SUNY Upstate Medical University
Syracuse, New York, 13210
Clinical Research of West Florida, Inc.
Tampa, Florida, 33606
Solace Clinical Research
Tustin, California, 92780
AARA Clinical Research - Rheumatology Specialty Center
Willow Grove, Pennsylvania, 19090
Willow Rheumatology and Wellness
Willowbrook, Illinois, 60527
UMass Chan Medical School
Worcester, Massachusetts, 01655
China12 sites
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100044
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Anhui Provincial Hospital (The First Affiliated Hospital of USTC)
Hefei, Anhui, 230001
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangx, 330008
Lanzhou University Second Hospital
Pudong, Shanghai Municipality, 200127
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200001
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050005
The Second Affiliated Hospital of Soochow University
Suzhou, 215025
Shanxi Bethune Hospital
Taiyuan, 030032
The First Affiliated Hospital of Ziamen University
Xiamen, 361003
Mexico8 sites
PanAmerican Clinical Research
Guadalajara, Jalisco, 44670
Centro de Estudios de Investigacion Basica Y Clinica SC
Guadalajara, 44690
Eme Red Hospitalaria
Mérida, Yucatán, 97000
Kohler and Milsten Research
Mérida, Yucatán, 97070
Clinstile, S.A. de C.V.
Mexico City, Cuidad de Mexico, 06700
Centro de Investigacion y Tratamiento Reumatologico S.C.
Mexico City, 11850
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubrian
Mexico City, 14080
Oaxaca Site Management Organization
Oaxaca City, 68000
Poland8 sites
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz, 85090
Centrum Medyczne Plejady
Krakow, Lesser Poland Voivodeship, 30-363
Krakowskie Centrum Medyczne
Krakow, 31501
SOMED CR
Lodz, 05260
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, 90153
Prywatna Praktyka Lekarska Prof Hab Med Pawel Hrycaj
Poznan, Greater Poland Voivodeship, 61-397
MICS Centrum Medyczne Warszawa
Warsaw, Masovian Voivodeship, 00-874
Pracownia Badan Klinicznych Salus
Wroclaw, 50570
Italy7 sites
Azienda Ospedaliero Universitaria di Ferrara
Ferrara, 44124
Ospedale Policlinico San Martino IRCCS
Genova, 16132
IRCCS Ospedale San Raffaele
Milan, 20132
Azienda Ospedaliero Universitaria Pisana
Pisa, 56124
Policlinico Universitario Campus Biomedico Di Roma
Roma, 00128
Ospedale San Giovanni Bosco
Torino, 10154
Centro Ricerche Cliniche Di Verona S.r.l.
Verona, 37134
Greece6 sites
Attikon University General Hospital
Chaïdári, Athens, 12462
University General Hospital of Heraklion
Heraklion, 71500
Olympion General Clinic
Pátrai, 26443
Kianous Stavros
Thessaloniki, 54636
General Hospital of Thessaloniki ''Hippokration''
Thessaloniki, 54642
General Hospital Asklepieio Voulas
Voula, Athens, 16673
Spain6 sites
Hospital Vall d'Hebron
Barcelona, 08035
FutureMeds DKF
Madrid, 28002
FuturMeds Madrid - Santa Elena
Madrid, 28003
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Virgen del Rocío
Seville, 41013
Taiwan6 sites
Buddhist Tzu Chi General Hospital
Chiayi City, 622
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362
Chung Shan Medical University Hospital
Taichung, 402
Taipei Medical University Hospital
Taipei, 110
Taipei Veterans General Hospital
Taipei, 1121
Chang Gung Memorial Hospital
Taoyuan, 333
Japan5 sites
Juntendo University Hospital
Bunkyō City, 113843
Hokkaido University Hospital
Kita-ku, Sapporo Hokkaido, 060-8648
Hospital of the University of Occupational and Environmental Health
Kitakyushu-shi, Fukuoka, 807-8556
Hospital of Japan Community Health Care Organization Chukyo Hospital
Nagoya, Aichi-ken, 457-8510
Hospital of Shinkenko Clinic
Naha, Okinawa, 900-001
Bulgaria3 sites
Medical Center Medtech Services EOOD
Haskovo, 6304
University Multiprofile Hospital for Active Treatment "Eurohospital Plovdiv"
Plovdiv, 4004
Diagnostic Consultative Center Convex EOOD
Sofia, 1404
Portugal3 sites
Hospital Egas Moniz
Lisbon, 1349019
ULS de Santa Maria, EPE - Hospital de Santa Maria
Lisbon, 1649-035
ULS da Arrábida, E.P.E. - Hospital de São Bernardo
Setúbal, 2910-446
South Africa3 sites
FARMOVS
Bloemfontein, 9301
Panorama Medical Centre
Cape Town, 7500
Dr A Naidoo
Umhlanga, 4319
Canada2 sites
Richmond Clinical Trials
Richmond, British Columbia, V6V 2L1
Riverside Professional Centre
Sydney, Nova Scotia, B1S 3N1
Germany2 sites
Uniklinik Koln
Cologne, 50937
Medicover Munchen Ost MVZ
München, Bavaria, 81667
Puerto Rico2 sites
Centro Reumatologico de Caguas
Caguas, 00725
Latin Clinical Trial Center
San Juan, 00909
Romania2 sites
Centrul Medical de Diagnostic si Tratament Ambulator NEOMED SRL
Brasov, 500283
Dr I Cantacuzino Clinical Hospital
Bucharest, 030167
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 Systemic Lupus Erythematosus
This study aims to examine the efficacy and safety of obexelimab in participants with systemic lupus erythematosus (SLE).
Read the detailed description
This study consists of a 24-week treatment period followed by a 12-week follow-up period. Patients must have a clinical diagnosis of SLE at least 24 weeks prior to screening and meet the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) Classification Criteria. To enter the Screening Period (Day -28 to Day -1) patients will have active SLE as defined by having: a) hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) ≥ 6 and clinical hSLEDAI ≥ 4, and b) British Isles Lupus Assessment Group (BILAG)-2004 Grade A or B in ≥ 1 organ system. Patients must be treated with one or more of the following background nonbiologic lupus standard of care therapies: oral corticosteroid, antimalarial, and/or immunosuppressant.
On Day 1, patients will be randomized 1:1 to obexelimab or placebo subcutaneous (SC) injection once per week (QW) for 24 weeks. All patients will return to the study site for scheduled visits at Week 2, Week 4, and then every 4 weeks thereafter until study completion. During the study, patients will undergo assessments for efficacy, safety, PK, PD, and immunogenicity.
Including screening and follow-up, the maximum duration of participation in this study for an individual patient is approximately 40 weeks (i.e., up to a 28-day Screening Period, 24-week Treatment Period, and a 12-week follow-up).
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Obexelimab, Placebo
- Keywords
- Systemic Lupus Erythematosus, SLE, Lupus
- Medical subject headings
- Lupus Erythematosus, Systemic
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 FcyRllb, 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 24 weeks. Receives: Drug: Obexelimab |
| Placebo | Placebo comparator | Placebo will be administered as a subcutaneous injection for 24 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
Proportion of patients who achieve a response according to the BILAG-Based Composite Lupus Assessment (BICLA) Response
Measured: 24 weeks
Secondary outcomes (1)
Secondary Outcome Measures
Proportion of patients who achieve response according to the Systemic Lupus Erythematosus Responder Index 4 (SRI-4).
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 posted19 Aug 2024
- Study start17 Sep 2024
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 190 participants (actual)
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
- NCT06559163
- Sponsor's protocol ID
- ZB012-02-001
- Acronym
- SunStone
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2024
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. 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 Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT06559163
- Acronym / sponsor ID
- SunStone / ZB012-02-001
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic Lupus Erythematosus, SLE, Lupus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Zenas BioPharma (USA), LLCIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 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 systemic lupus erythematosus (SLE).
Detailed description
This study consists of a 24-week treatment period followed by a 12-week follow-up period. Patients must have a clinical diagnosis of SLE at least 24 weeks prior to screening and meet the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) Classification Criteria. To enter the Screening Period (Day -28 to Day -1) patients will have active SLE as defined by having: a) hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) ≥ 6 and clinical hSLEDAI ≥ 4, and b) British Isles Lupus Assessment Group (BILAG)-2004 Grade A or B in ≥ 1 organ system. Patients must be treated with one or more of the following background nonbiologic lupus standard of care therapies: oral corticosteroid, antimalarial, and/or immunosuppressant.
On Day 1, patients will be randomized 1:1 to obexelimab or placebo subcutaneous (SC) injection once per week (QW) for 24 weeks. All patients will return to the study site for scheduled visits at Week 2, Week 4, and then every 4 weeks thereafter until study completion. During the study, patients will undergo assessments for efficacy, safety, PK, PD, and immunogenicity.
Including screening and follow-up, the maximum duration of participation in this study for an individual patient is approximately 40 weeks (i.e., up to a 28-day Screening Period, 24-week Treatment Period, and a 12-week follow-up).
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 |
|---|---|---|
| Obexelimab | Experimental | Drug: ObexelimabObexelimab will be administered as a subcutaneous injection for 24 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be administered as a subcutaneous injection for 24 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females, ≥ 18 to ≤ 70 years of age
- Diagnosed with SLE at least 24 weeks prior to screening and meets the 2019 EULAR/ACR classification criteria.
- Patient has all 3 of the following based on features active on the day of the visits:
- Patients must be treated with one or more of the following background nonbiologic lupus standard of care therapies: oral corticosteroid, antimalarial, and/or immunosuppressant.
Key exclusion criteria (5 listed)
- Active lupus nephritis for which, in the opinion of the investigator or the central adjudicator, current medications are insufficient for patient's safety or additional therapy that is not permitted in the protocol is needed.
- A history of thrombosis or embolism in the previous 6 months before the Screening visit, or previous 12 months associated with antiphospholipid syndrome (APS) or another relevant hypercoagulable state.
- Any active skin conditions other than cutaneous lupus erythematosus (CLE) that may interfere with the study assessment of CLE such as, but not limited to, psoriasis, dermatomyositis, and systemic sclerosis.
- Active severe neuropsychiatric or central nervous system SLE.
- Current inflammatory disease other than SLE (including, but not limited to, rheumatoid arthritis, psoriatic arthritis, spondyloarthropathy, reactive arthritis, scleroderma, dermatomyositis) that may interfere with the assessment of lupus signs and symptoms in the opinion of the investigator or central adjudicator.
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 FcyRllb, resulting in down regulation of B cell activity. | Drug | Obexelimab |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Primary Outcome Measure
Time frame: 24 weeks
Proportion of patients who achieve a response according to the BILAG-Based Composite Lupus Assessment (BICLA) Response
1 secondary outcome
Secondary Outcome Measures
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 18 Aug 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
110 sites in 18 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 Systemic Lupus Erythematosus, run by Zenas BioPharma (USA), LLC at 110 sites in 18 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 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 110 sites in United States, China, Mexico, Poland, Italy and 13 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?
Primary Outcome Measure (time frame: 24 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 18 Aug 2026.