A Study of Obexelimab in Patients With Systemic Lupus Erythematosus
NCT ID: NCT06559163
Last Updated: 2025-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
190 participants
INTERVENTIONAL
2024-09-17
2026-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Obexelimab
Obexelimab will be administered as a subcutaneous injection for 24 weeks.
Obexelimab
Obexelimab is a monoclonal antibody that simultaneously binds CD19 and FcyRllb, resulting in down regulation of B cell activity.
Placebo
Placebo will be administered as a subcutaneous injection for 24 weeks.
Placebo
Placebo
Interventions
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Obexelimab
Obexelimab is a monoclonal antibody that simultaneously binds CD19 and FcyRllb, resulting in down regulation of B cell activity.
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
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Zenas BioPharma (USA), LLC
INDUSTRY
Responsible Party
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Locations
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Sierra Pacific Arthritis and Rheumatology Centers
Fresno, California, United States
California Research Institute
Huntington Park, California, United States
University of California, San Diego
La Jolla, California, United States
Clinical Research of West Florida, Inc
Clearwater, Florida, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Accurate Clinical Research
Lake Charles, Louisiana, United States
Henry Ford Hospital
Detroit, Michigan, United States
June DO, PC
Lansing, Michigan, United States
Juno DO, PC
Lansing, Michigan, United States
DJL Clinical Research PLLC
Charlotte, North Carolina, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States
Penn State - Hershey Medical Center
Hershey, Pennsylvania, United States
Prolato Clinical Research Center (PCRC)
Houston, Texas, United States
Accurate Clinical Research
Houston, Texas, United States
Prime Clinical Research - Mansfield
Mansfield, Texas, United States
CHU de Liege
Liège, , Belgium
Medical Center Medtech Services EOOD
Haskovo, , Bulgaria
University Multiprofile Hospital for Active Treatment "Eurohospital Plovdiv"
Plovdiv, , Bulgaria
Richmond Clinical Trials
Richmond, British Columbia, Canada
Riverside Professional Centre
Sydney, Nova Scotia, Canada
Anhui Provincial Hospital (The First Affiliated Hospital of USTC)
Hefei, Anhui, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangx, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangx, China
Lanzhou University Second Hospital
Pudong, Shanghai Municipality, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
The Second Affiliated Hospital of Soochow University
Suzhou, , China
Shanxi Bethune Hospital
Taiyuan, , China
The First Affiliated Hospital of Ziamen University
Xiamen, , China
Sjaellands Universitetshospital, Koge
Køge, , Denmark
Medicover Munchen Ost MVZ
München, Bavaria, Germany
Uniklinik Koln
Cologne, , Germany
Attikon University General Hospital
Chaïdári, Athens, Greece
General Hospital Asklepieio Voulas
Voula, Athens, Greece
University General Hospital of Heraklion
Heraklion, , Greece
Olympion General Clinic
Pátrai, , Greece
Kianous Stavros
Thessaloniki, , Greece
General Hospital of Thessaloniki ''Hippokration''
Thessaloniki, , Greece
Policlinico Universitario Campus Biomedico Di Roma
Roma, , Italy
Centro Ricerche Cliniche Di Verona S.r.l.
Verona, , Italy
Hospital of Japan Community Health Care Organization Chukyo Hospital
Nagoya, Aichi-ken, Japan
Hospital of the University of Occupational and Environmental Health
Kitakyushu-shi, Fukuoka, Japan
Hospital of Shinkenko Clinic
Naha, Okinawa, Japan
Hokkaido University Hospital
Kita-ku, Sapporo Hokkaido, Japan
Juntendo University Hospital
Bunkyō City, , Japan
Clinstile, S.A. de C.V.
Mexico City, Cuidad de Mexico, Mexico
PanAmerican Clinical Research
Guadalajara, Jalisco, Mexico
Eme Red Hospitalaria
Mérida, Yucatán, Mexico
Kohler and Milsten Research
Mérida, Yucatán, Mexico
Oaxaca Site Management Organization
Oaxaca City, , Mexico
Prywatna Praktyka Lekarska Prof Hab Med Pawel Hrycaj
Poznan, Greater Poland Voivodeship, Poland
Centrum Medyczne Plejady
Krakow, Lesser Poland Voivodeship, Poland
MICS Centrum Medyczne Warszawa
Warsaw, Masovian Voivodeship, Poland
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz, , Poland
Krakowskie Centrum Medyczne
Krakow, , Poland
SOMED CR
Lodz, , Poland
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, , Poland
Pracownia Badan Klinicznych Salus
Wroclaw, , Poland
Hospital Egas Moniz
Lisbon, , Portugal
ULS de Santa Maria, EPE - Hospital de Santa Maria
Lisbon, , Portugal
ULS da Arrábida, E.P.E. - Hospital de São Bernardo
Setúbal, , Portugal
Centro Reumatologico de Caguas
Caguas, Puerto Rico, Puerto Rico
Latin Clinical Trial Center
San Juan, Puerto Rico, Puerto Rico
Centrul Medical de Diagnostic si Tratament Ambulator NEOMED SRL
Brasov, , Romania
Dr I Cantacuzino Clinical Hospital
Bucharest, , Romania
FARMOVS
Bloemfontein, , South Africa
Panorama Medical Centre
Cape Town, , South Africa
FutureMeds DKF
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Buddhist Tzu Chi General Hospital
Chiayi City, , Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
Taipei Medical University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Ramachandran Srinivasan
Role: primary
DoQuyen Huynh
Role: primary
Arezou Khosroshahi
Role: primary
Alireza Meysami
Role: primary
Christina Arriens
Role: primary
Nancy Olsen
Role: primary
Christian Von Frenckell
Role: primary
Krasimir Kraev
Role: primary
Dimitar Penev
Role: primary
Lucas Alexandra
Role: primary
Juris Lazovskis
Role: primary
Zhu Chen
Role: primary
Yanying Liu
Role: primary
Zhanguo Li
Role: primary
Yujing Ye
Role: primary
Dongzhou Liu
Role: primary
Gao Lixia
Role: primary
Xinwang Duan
Role: primary
Haili Shen
Role: primary
Ting Li
Role: primary
Zhichun Liu
Role: primary
Zhang
Role: primary
Guixiu Shi
Role: primary
Ada Colic
Role: primary
David Kofler
Role: primary
Philipp Köhler
Role: primary
Dimitrios Boumpas
Role: primary
Antonia Elezoglou
Role: primary
Podromos Sidiropoulos
Role: primary
Andreas Bounas
Role: primary
Lucas Settas
Role: primary
Theodoros Dimitroulas
Role: primary
Roberto Giacomelli
Role: primary
Giovonni Orsolini
Role: primary
Masanari Kodera
Role: primary
Masaru Kato
Role: primary
Kentaro Minowa
Role: primary
Juan Manuel Martinez Noriega
Role: primary
Gabriela Sierra-Jimenez
Role: primary
Miguel Angel Angulo Gamez
Role: primary
Jesus Abraham Simon Campos
Role: primary
Sergio Garcia Mendez
Role: primary
Pawel Hrycaj
Role: primary
Magdalena Celinska-Lowenhoff
Role: primary
Malgorzata Gryka-Marton
Role: primary
Katarzyna Kolossa
Role: primary
Przemyslaw Borowy
Role: primary
Tomasz Budlewski
Role: primary
Ilona Kurnatowska
Role: primary
Katarzyna Rachwal-Siek
Role: primary
Carina Lopes
Role: primary
Nikita Khmelinskii
Role: primary
Brigas Daniela
Role: primary
Liliana Duca
Role: primary
Ana Maria Gheorghiu
Role: primary
Eduard Krantz
Role: primary
Ingrid Louw
Role: primary
Karin Freitag
Role: primary
Angel Robles-Marhuenda
Role: primary
Jose Salvardor Garcia Morillo
Role: primary
Ning-Sheng Lai
Role: primary
Jui-Cheng Tseng
Role: primary
Cheng-Chung Wei
Role: primary
Chi-Ching Chang
Role: primary
Ming-Han Chen
Role: primary
Yao-Fan Fang
Role: primary
Other Identifiers
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ZB012-02-001
Identifier Type: -
Identifier Source: org_study_id
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