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A Study of Obexelimab in Patients With Systemic Lupus Erythematosus

NCT06559163 · Zenas BioPharma (USA), LLC
In plain English

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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
About this study
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).
Eligibility criteria
Inclusion Criteria: 1. Males and females, ≥ 18 to ≤ 70 years of age 2. Diagnosed with SLE at least 24 weeks prior to screening and meets the 2019 EULAR/ACR classification criteria. 3. Patient has all 3 of the following based on features active on the day of the visits: 1. hSLEDAI ≥ 6 and clinical hSLEDAI ≥ 4 at screening, and clinical hSLEDAI ≥ 4 at Day 1 Note: Clinical points exclude laboratory tests, except proteinuria. 2. BILAG-2004 Grade A or B in ≥ 1 organ system at screening and Day 1. 3. 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. 4. Patients must be treated with one or more of the following background nonbiologic lupus standard of care therapies: oral corticosteroid, antimalarial, and/or immunosuppressant. Exclusion Criteria: 1. 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. 2. 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. 3. 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. 4. Active severe neuropsychiatric or central nervous system SLE. 5. 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.
Study design
Enrollment target: 190 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2024-09-17
Estimated completion: 2026-09
Last updated: 2025-07-30
Interventions
Drug: ObexelimabDrug: Placebo
Primary outcomes
  • Primary Outcome Measure (24 weeks)
Sponsor
Zenas BioPharma (USA), LLC · industry
Contacts & investigators
ContactPatient and Medical Information · contact · clinicaltrialsinfo@zenasbio.com · 833-269-4696
All locations (82)
Sierra Pacific Arthritis and Rheumatology CentersRecruiting
Fresno, California, United States
California Research InstituteRecruiting
Huntington Park, California, United States
University of California, San DiegoRecruiting
La Jolla, California, United States
Clinical Research of West Florida, IncRecruiting
Clearwater, Florida, United States
Clinical Research of West Florida, Inc.Recruiting
Tampa, Florida, United States
Emory UniversityRecruiting
Atlanta, Georgia, United States
Accurate Clinical ResearchRecruiting
Lake Charles, Louisiana, United States
Henry Ford HospitalRecruiting
Detroit, Michigan, United States
June DO, PCRecruiting
Lansing, Michigan, United States
Juno DO, PCRecruiting
Lansing, Michigan, United States
DJL Clinical Research PLLCRecruiting
Charlotte, North Carolina, United States
Oklahoma Medical Research FoundationRecruiting
Oklahoma City, Oklahoma, United States
Penn State - Hershey Medical CenterRecruiting
Hershey, Pennsylvania, United States
Prolato Clinical Research Center (PCRC)Recruiting
Houston, Texas, United States
Accurate Clinical ResearchRecruiting
Houston, Texas, United States
Prime Clinical Research - MansfieldRecruiting
Mansfield, Texas, United States
CHU de LiegeRecruiting
Liège, Belgium
Medical Center Medtech Services EOODRecruiting
Haskovo, Bulgaria
University Multiprofile Hospital for Active Treatment "Eurohospital Plovdiv"Recruiting
Plovdiv, Bulgaria
Richmond Clinical TrialsRecruiting
Richmond, British Columbia, Canada
Riverside Professional CentreRecruiting
Sydney, Nova Scotia, Canada
Anhui Provincial Hospital (The First Affiliated Hospital of USTC)Recruiting
Hefei, Anhui, China
Beijing Friendship Hospital, Capital Medical UniversityRecruiting
Beijing, Beijing Municipality, China
Peking University People's HospitalRecruiting
Beijing, Beijing Municipality, China
The First Affiliated Hospital, Sun Yat-sen UniversityRecruiting
Guangzhou, Guangdong, China
Shenzhen People's HospitalRecruiting
Shenzhen, Guangdong, China
The Second Hospital of Hebei Medical UniversityRecruiting
Shijiazhuang, Hebei, China
The Second Affiliated Hospital of Nanchang UniversityRecruiting
Nanchang, Jiangx, China
The Second Affiliated Hospital of Nanchang UniversityRecruiting
Nanchang, Jiangx, China
Lanzhou University Second HospitalRecruiting
Pudong, Shanghai Municipality, China
Renji Hospital, Shanghai Jiaotong University School of MedicineRecruiting
Shanghai, Shanghai Municipality, China
The Second Affiliated Hospital of Soochow UniversityRecruiting
Suzhou, China
Shanxi Bethune HospitalRecruiting
Taiyuan, China
The First Affiliated Hospital of Ziamen UniversityRecruiting
Xiamen, China
Sjaellands Universitetshospital, KogeRecruiting
Køge, Denmark
Medicover Munchen Ost MVZRecruiting
München, Bavaria, Germany
Uniklinik KolnRecruiting
Cologne, Germany
Attikon University General HospitalRecruiting
Chaïdári, Athens, Greece
General Hospital Asklepieio VoulasRecruiting
Voula, Athens, Greece
University General Hospital of HeraklionRecruiting
Heraklion, Greece
Olympion General ClinicRecruiting
Pátrai, Greece
Kianous StavrosRecruiting
Thessaloniki, Greece
General Hospital of Thessaloniki ''Hippokration''Recruiting
Thessaloniki, Greece
Policlinico Universitario Campus Biomedico Di RomaRecruiting
Roma, Italy
Centro Ricerche Cliniche Di Verona S.r.l.Recruiting
Verona, Italy
Hospital of Japan Community Health Care Organization Chukyo HospitalRecruiting
Nagoya, Aichi-ken, Japan
Hospital of the University of Occupational and Environmental HealthRecruiting
Kitakyushu-shi, Fukuoka, Japan
Hospital of Shinkenko ClinicRecruiting
Naha, Okinawa, Japan
Hokkaido University HospitalRecruiting
Kita-ku, Sapporo Hokkaido, Japan
Juntendo University HospitalRecruiting
Bunkyō City, Japan
Clinstile, S.A. de C.V.Recruiting
Mexico City, Cuidad de Mexico, Mexico
PanAmerican Clinical ResearchRecruiting
Guadalajara, Jalisco, Mexico
Eme Red HospitalariaRecruiting
Mérida, Yucatán, Mexico
Kohler and Milsten ResearchRecruiting
Mérida, Yucatán, Mexico
Oaxaca Site Management OrganizationRecruiting
Oaxaca City, Mexico
Prywatna Praktyka Lekarska Prof Hab Med Pawel HrycajRecruiting
Poznan, Greater Poland Voivodeship, Poland
Centrum Medyczne PlejadyRecruiting
Krakow, Lesser Poland Voivodeship, Poland
MICS Centrum Medyczne WarszawaRecruiting
Warsaw, Masovian Voivodeship, Poland
MICS Centrum Medyczne BydgoszczRecruiting
Bydgoszcz, Poland
Krakowskie Centrum MedyczneRecruiting
Krakow, Poland
SOMED CRRecruiting
Lodz, Poland
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w LodziRecruiting
Lodz, Poland
Pracownia Badan Klinicznych SalusRecruiting
Wroclaw, Poland
Hospital Egas MonizRecruiting
Lisbon, Portugal
ULS de Santa Maria, EPE - Hospital de Santa MariaRecruiting
Lisbon, Portugal
ULS da Arrábida, E.P.E. - Hospital de São BernardoRecruiting
Setúbal, Portugal
Centro Reumatologico de CaguasRecruiting
Caguas, Puerto Rico, Puerto Rico
Latin Clinical Trial CenterRecruiting
San Juan, Puerto Rico, Puerto Rico
Centrul Medical de Diagnostic si Tratament Ambulator NEOMED SRLRecruiting
Brasov, Romania
Dr I Cantacuzino Clinical HospitalRecruiting
Bucharest, Romania
FARMOVSRecruiting
Bloemfontein, South Africa
Panorama Medical CentreRecruiting
Cape Town, South Africa
FutureMeds DKFRecruiting
Madrid, Spain
Hospital Universitario Ramón y CajalRecruiting
Madrid, Spain
Hospital Universitario La PazRecruiting
Madrid, Spain
Hospital Universitario Virgen del RocíoRecruiting
Seville, Spain
Buddhist Tzu Chi General HospitalRecruiting
Chiayi City, Taiwan
Kaohsiung Veterans General HospitalRecruiting
Kaohsiung City, Taiwan
Chung Shan Medical University HospitalRecruiting
Taichung, Taiwan
Taipei Medical University HospitalRecruiting
Taipei, Taiwan
Taipei Veterans General HospitalRecruiting
Taipei, Taiwan
Chang Gung Memorial HospitalRecruiting
Taoyuan District, Taiwan