A Study of Obexelimab in Patients With Systemic Lupus Erythematosus

Last updated: May 6, 2025
Sponsor: Zenas BioPharma (USA), LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Systemic Lupus Erythematosus

Cutaneous Lupus Erythematosus

Musculoskeletal Diseases

Treatment

Obexelimab

Placebo

Clinical Study ID

NCT06559163
ZB012-02-001
  • Ages 18-70
  • All Genders

Study Summary

This study aims to examine the efficacy and safety of obexelimab in participants with systemic lupus erythematosus (SLE).

Eligibility Criteria

Inclusion

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/ACRclassification criteria.

  3. Patient has all 3 of the following based on features active on the day of thevisits:

  4. hSLEDAI ≥ 6 and clinical hSLEDAI ≥ 4 at screening, and clinical hSLEDAI ≥ 4 atDay 1 Note: Clinical points exclude laboratory tests, except proteinuria.

  5. BILAG-2004 Grade A or B in ≥ 1 organ system at screening and Day 1.

  6. In the opinion of the investigator and the central adjudicator, there issufficient disease activity to warrant enrollment into a clinical study with aninvestigational agent.

  7. Patients must be treated with one or more of the following background nonbiologiclupus standard of care therapies: oral corticosteroid, antimalarial, and/orimmunosuppressant.

Exclusion

Exclusion Criteria:

  1. Active lupus nephritis for which, in the opinion of the investigator or the centraladjudicator, current medications are insufficient for patient's safety or additionaltherapy that is not permitted in the protocol is needed.

  2. A history of thrombosis or embolism in the previous 6 months before the Screeningvisit, or previous 12 months associated with antiphospholipid syndrome (APS) oranother relevant hypercoagulable state.

  3. Any active skin conditions other than cutaneous lupus erythematosus (CLE) that mayinterfere 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 signsand symptoms in the opinion of the investigator or central adjudicator.

Study Design

Total Participants: 190
Treatment Group(s): 2
Primary Treatment: Obexelimab
Phase: 2
Study Start date:
September 17, 2024
Estimated Completion Date:
September 30, 2026

Study 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).

Connect with a study center

  • CHU de Liege

    Liege,
    Belgium

    Active - Recruiting

  • University Multiprofile Hospital for Active Treatment "Eurohospital Plovdiv"

    Plovdiv, 4004
    Bulgaria

    Active - Recruiting

  • Richmond Clinical Trials

    Richmond, British Columbia V6V 2L1
    Canada

    Active - Recruiting

  • Riverside Professional Centre

    Sydney, Nova Scotia B1S 3N1
    Canada

    Active - Recruiting

  • Anhui Provincial Hospital (The First Affiliated Hospital of USTC)

    Hefei, Anhui 230001
    China

    Active - Recruiting

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing 100044
    China

    Active - Recruiting

  • Peking University People's Hospital

    Beijing, Beijing 100044
    China

    Active - Recruiting

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • Shenzhen People's Hospital

    Shenzhen, Guangdong 518020
    China

    Active - Recruiting

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei 050005
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangx 330008
    China

    Active - Recruiting

  • Lanzhou University Second Hospital

    Pudong, Shanghai 200127
    China

    Active - Recruiting

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai 200001
    China

    Active - Recruiting

  • Medicover Munchen Ost MVZ

    München, Bavaria 81667
    Germany

    Active - Recruiting

  • Uniklinik Koln

    Cologne,
    Germany

    Active - Recruiting

  • Attikon University General Hospital

    Chaidari, Athens 12462
    Greece

    Active - Recruiting

  • General Hospital Asklepieio Voulas

    Voula, Athens 16673
    Greece

    Active - Recruiting

  • General Hospital of Thessaloniki ''Hippokration''

    Thessaloniki, 54642
    Greece

    Active - Recruiting

  • Centro Ricerche Cliniche Di Verona S.r.l.

    Verona, 37134
    Italy

    Active - Recruiting

  • Hospital of Japan Community Health Care Organization Chukyo Hospital

    Nagoya-shi, Aichi 457-8510
    Japan

    Active - Recruiting

  • Hospital of the University of Occupational and Environmental Health

    Kitakyushu-shi, Fukuoka 807-8556
    Japan

    Active - Recruiting

  • Hospital of Shinkenko Clinic

    Naha-city, Okinawa 900-001
    Japan

    Active - Recruiting

  • Hokkaido University Hospital

    Kita-Ku, Sapporo Hokkaido 060-8648
    Japan

    Active - Recruiting

  • Clinstile, S.A. de C.V.

    Mexico City, Cuidad de Mexico
    Mexico

    Active - Recruiting

  • PanAmerican Clinical Research

    Guadalajara, Jalisco
    Mexico

    Active - Recruiting

  • Eme Red Hospitalaria

    Merida, Yucatán
    Mexico

    Active - Recruiting

  • Kohler and Milsten Research

    Merida, Yucatán
    Mexico

    Active - Recruiting

  • Centrum Medyczne Plejady

    Krakow, Malopolskie 30-363
    Poland

    Active - Recruiting

  • MICS Centrum Medyczne Warszawa

    Warsaw, Mazowieckie 00-874
    Poland

    Active - Recruiting

  • Prywatna Praktyka Lekarska Prof Hab Med Pawel Hrycaj

    Poznan, Wielkopolskie 61-397
    Poland

    Active - Recruiting

  • SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

    Lodz, 90153
    Poland

    Active - Recruiting

  • ULS de Santa Maria, EPE - Hospital de Santa Maria

    Lisboa, 1649-035
    Portugal

    Active - Recruiting

  • ULS da Arrábida, E.P.E. - Hospital de São Bernardo

    Setúbal, 2910-446
    Portugal

    Active - Recruiting

  • Centro Reumatologico de Caguas

    Caguas, 00725
    Puerto Rico

    Active - Recruiting

  • Latin Clinical Trial Center

    San Juan, 00909
    Puerto Rico

    Active - Recruiting

  • Centrul Medical de Diagnostic si Tratament Ambulator NEOMED SRL

    Brasov, 500283
    Romania

    Active - Recruiting

  • FutureMeds DKF

    Madrid, 28002
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocío

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362
    Taiwan

    Active - Recruiting

  • Sierra Pacific Arthritis and Rheumatology Centers

    Fresno, California 93710
    United States

    Active - Recruiting

  • University of California, San Diego

    La Jolla, California 92037
    United States

    Active - Recruiting

  • Clinical Research of West Florida, Inc

    Clearwater, Florida 33765
    United States

    Active - Recruiting

  • Clinical Research of West Florida, Inc.

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • Accurate Clinical Research

    Lake Charles, Louisiana 70605
    United States

    Active - Recruiting

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • June DO, PC

    Lansing, Michigan 48911
    United States

    Active - Recruiting

  • Juno DO, PC

    Lansing, Michigan 48911
    United States

    Active - Recruiting

  • DJL Clinical Research PLLC

    Charlotte, North Carolina 28211
    United States

    Active - Recruiting

  • Oklahoma Medical Research Foundation

    Oklahoma City, Oklahoma 73104-5005
    United States

    Active - Recruiting

  • Penn State - Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

  • Accurate Clinical Research

    Houston, Texas 77089
    United States

    Active - Recruiting

  • Prolato Clinical Research Center (PCRC)

    Houston, Texas 77054
    United States

    Active - Recruiting

  • Prime Clinical Research - Mansfield

    Mansfield, Texas 76063
    United States

    Active - Recruiting

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