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A Study of Obexelimab in Patients With Systemic Lupus Erythematosus
Sponsor: Zenas BioPharma (USA), LLC
Summary
This study aims to examine the efficacy and safety of obexelimab in participants with systemic lupus erythematosus (SLE).
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
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
190
Start Date
2024-09-17
Completion Date
2026-09
Last Updated
2025-07-30
Healthy Volunteers
No
Conditions
Interventions
Obexelimab
Obexelimab is a monoclonal antibody that simultaneously binds CD19 and FcyRllb, resulting in down regulation of B cell activity.
Placebo
Placebo
Locations (82)
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