A Study of Obexelimab in Patients With Systemic Lupus Erythematosus
- Registration Number
- NCT06559163
- Lead Sponsor
- Zenas BioPharma (USA), LLC
- Brief 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 190
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo will be administered as a subcutaneous injection for 24 weeks. Obexelimab Obexelimab Obexelimab will be administered as a subcutaneous injection for 24 weeks.
- Primary Outcome Measures
Name Time Method Primary Outcome Measure 24 weeks Proportion of patients who achieve a response according to the BILAG-Based Composite Lupus Assessment (BICLA) Response
- Secondary Outcome Measures
Name Time Method Secondary Outcome Measures 24 weeks Proportion of patients who achieve response according to the Systemic Lupus Erythematosus Responder Index 4 (SRI-4).
Trial Locations
- Locations (54)
University of California, San Diego
🇺🇸La Jolla, California, United States
Penn State - Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
CHU de Liege
🇧🇪Liege, Belgium
Richmond Clinical Trials
🇨🇦Richmond, British Columbia, Canada
Anhui Provincial Hospital (The First Affiliated Hospital of USTC)
🇨🇳Hefei, Anhui, China
Shenzhen People's Hospital
🇨🇳Shenzhen, Guangdong, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
🇵🇱Lodz, Poland
Sierra Pacific Arthritis and Rheumatology Centers
🇺🇸Fresno, California, United States
Clinical Research of West Florida, Inc
🇺🇸Clearwater, Florida, United States
Clinical Research of West Florida, Inc.
🇺🇸Tampa, Florida, United States
Accurate Clinical Research
🇺🇸Houston, Texas, 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
PanAmerican Clinical Research
🇲🇽Guadalajara, Jalisco, Mexico
Oklahoma Medical Research Foundation
🇺🇸Oklahoma City, Oklahoma, United States
Prolato Clinical Research Center (PCRC)
🇺🇸Houston, Texas, United States
Prime Clinical Research - Mansfield
🇺🇸Mansfield, Texas, United States
University Multiprofile Hospital for Active Treatment "Eurohospital Plovdiv"
🇧🇬Plovdiv, Bulgaria
Riverside Professional Centre
🇨🇦Sydney, Nova Scotia, Canada
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
The Second Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangx, China
Lanzhou University Second Hospital
🇨🇳Pudong, Shanghai, China
Medicover Munchen Ost MVZ
🇩🇪München, Bavaria, Germany
Uniklinik Koln
🇩🇪Cologne, Germany
Attikon University General Hospital
🇬🇷Chaidari, Athens, Greece
General Hospital Asklepieio Voulas
🇬🇷Voula, Athens, Greece
General Hospital of Thessaloniki ''Hippokration''
🇬🇷Thessaloniki, Greece
Centro Ricerche Cliniche Di Verona S.r.l.
🇮🇹Verona, Italy
Hospital of Japan Community Health Care Organization Chukyo Hospital
🇯🇵Nagoya-shi, Aichi, Japan
Hospital of the University of Occupational and Environmental Health
🇯🇵Kitakyushu-shi, Fukuoka, Japan
Hospital of Shinkenko Clinic
🇯🇵Naha-city, Okinawa, Japan
Hokkaido University Hospital
🇯🇵Kita-Ku, Sapporo Hokkaido, Japan
Clinstile, S.A. de C.V.
🇲🇽Mexico City, Cuidad de Mexico, Mexico
Eme Red Hospitalaria
🇲🇽Merida, Yucatán, Mexico
Kohler and Milsten Research
🇲🇽Merida, Yucatán, Mexico
Centrum Medyczne Plejady
🇵🇱Krakow, Malopolskie, Poland
MICS Centrum Medyczne Warszawa
🇵🇱Warsaw, Mazowieckie, Poland
Prywatna Praktyka Lekarska Prof Hab Med Pawel Hrycaj
🇵🇱Poznan, Wielkopolskie, Poland
ULS de Santa Maria, EPE - Hospital de Santa Maria
🇵🇹Lisboa, Portugal
ULS da Arrábida, E.P.E. - Hospital de São Bernardo
🇵🇹Setúbal, Portugal
Centro Reumatologico de Caguas
🇵🇷Caguas, Puerto Rico
Latin Clinical Trial Center
🇵🇷San Juan, Puerto Rico
Centrul Medical de Diagnostic si Tratament Ambulator NEOMED SRL
🇷🇴Brasov, Romania
FutureMeds DKF
🇪🇸Madrid, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario Virgen del Rocío
🇪🇸Sevilla, Spain
Kaohsiung Veterans General Hospital
🇨🇳Kaohsiung City, Taiwan