A Study of Obexelimab in Patients With Systemic Lupus Erythematosus
Start Date
9/17/2024
Completion Date
9/1/2026
Summary
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).
Eligibility Criteria
Age Range: 18 years to 70 years
Interventions
Obexelimab
Placebo
Conditions
Locations
Sierra Pacific Arthritis and Rheumatology Centers
Fresno, California 93710
United States
California Research Institute
Huntington Park, California 90255
United States
University of California, San Diego
La Jolla, California 92037
United States
Clinical Research of West Florida, Inc
Clearwater, Florida 33765
United States
Clinical Research of West Florida, Inc.
Tampa, Florida 33606
United States
Emory University
Atlanta, Georgia 30322
United States
Accurate Clinical Research
Lake Charles, Louisiana 70605
United States
Henry Ford Hospital
Detroit, Michigan 48202
United States
June DO, PC
Lansing, Michigan 48911
United States
Juno DO, PC
Lansing, Michigan 48911
United States
DJL Clinical Research PLLC
Charlotte, North Carolina 28211
United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma 73104-5005
United States
Penn State - Hershey Medical Center
Hershey, Pennsylvania 17033
United States
Prolato Clinical Research Center (PCRC)
Houston, Texas 77054
United States
Accurate Clinical Research
Houston, Texas 77089
United States
Prime Clinical Research - Mansfield
Mansfield, Texas 76063
United States
CHU de Liege
Liège,
Belgium
Medical Center Medtech Services EOOD
Haskovo, 6304
Bulgaria
University Multiprofile Hospital for Active Treatment "Eurohospital Plovdiv"
Plovdiv, 4004
Bulgaria
Richmond Clinical Trials
Richmond, British Columbia V6V 2L1
Canada
Riverside Professional Centre
Sydney, Nova Scotia B1S 3N1
Canada
Anhui Provincial Hospital (The First Affiliated Hospital of USTC)
Hefei, Anhui 230001
China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality 100044
China
Peking University People's Hospital
Beijing, Beijing Municipality 100044
China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
China
Shenzhen People's Hospital
Shenzhen, Guangdong 518020
China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei 050005
China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangx 330008
China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangx 330008
China
Lanzhou University Second Hospital
Pudong, Shanghai Municipality 200127
China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality 200001
China
The Second Affiliated Hospital of Soochow University
Suzhou, 215025
China
Shanxi Bethune Hospital
Taiyuan, 030032
China
The First Affiliated Hospital of Ziamen University
Xiamen, 361003
China
Sjaellands Universitetshospital, Koge
Køge, 4600
Denmark
Medicover Munchen Ost MVZ
München, Bavaria 81667
Germany
Uniklinik Koln
Cologne,
Germany
Attikon University General Hospital
Chaïdári, Athens 12462
Greece
General Hospital Asklepieio Voulas
Voula, Athens 16673
Greece
University General Hospital of Heraklion
Heraklion, 71500
Greece
Olympion General Clinic
Pátrai, 26443
Greece
Kianous Stavros
Thessaloniki, 54636
Greece
General Hospital of Thessaloniki ''Hippokration''
Thessaloniki, 54642
Greece
Policlinico Universitario Campus Biomedico Di Roma
Roma, 00128
Italy
Centro Ricerche Cliniche Di Verona S.r.l.
Verona, 37134
Italy
Hospital of Japan Community Health Care Organization Chukyo Hospital
Nagoya, Aichi-ken 457-8510
Japan
Hospital of the University of Occupational and Environmental Health
Kitakyushu-shi, Fukuoka 807-8556
Japan
Hospital of Shinkenko Clinic
Naha, Okinawa 900-001
Japan
Hokkaido University Hospital
Kita-ku, Sapporo Hokkaido 060-8648
Japan
Juntendo University Hospital
Bunkyō City, 113843
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, 68000
Mexico
Prywatna Praktyka Lekarska Prof Hab Med Pawel Hrycaj
Poznan, Greater Poland Voivodeship 61-397
Poland
Centrum Medyczne Plejady
Krakow, Lesser Poland Voivodeship 30-363
Poland
MICS Centrum Medyczne Warszawa
Warsaw, Masovian Voivodeship 00-874
Poland
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz, 85090
Poland
Krakowskie Centrum Medyczne
Krakow, 31501
Poland
SOMED CR
Lodz, 05260
Poland
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, 90153
Poland
Pracownia Badan Klinicznych Salus
Wroclaw, 50570
Poland
Hospital Egas Moniz
Lisbon, 1349019
Portugal
ULS de Santa Maria, EPE - Hospital de Santa Maria
Lisbon, 1649-035
Portugal
ULS da Arrábida, E.P.E. - Hospital de São Bernardo
Setúbal, 2910-446
Portugal
Centro Reumatologico de Caguas
Caguas, Puerto Rico 00725
Puerto Rico
Latin Clinical Trial Center
San Juan, Puerto Rico 00909
Puerto Rico
Centrul Medical de Diagnostic si Tratament Ambulator NEOMED SRL
Brasov, 500283
Romania
Dr I Cantacuzino Clinical Hospital
Bucharest, 030167
Romania
FARMOVS
Bloemfontein, 9301
South Africa
Panorama Medical Centre
Cape Town, 7500
South Africa
FutureMeds DKF
Madrid, 28002
Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034
Spain
Hospital Universitario La Paz
Madrid, 28046
Spain
Hospital Universitario Virgen del Rocío
Seville, 41013
Spain
Buddhist Tzu Chi General Hospital
Chiayi City, 622
Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362
Taiwan
Chung Shan Medical University Hospital
Taichung, 402
Taiwan
Taipei Medical University Hospital
Taipei, 110
Taiwan
Taipei Veterans General Hospital
Taipei, 1121
Taiwan
Chang Gung Memorial Hospital
Taoyuan, 333
Taiwan