A Study of Obexelimab in Patients with Systemic Lupus Erythematosus

Phase 2

Recruiting

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: Placebo; Drug: Obexelimab

• 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).

Study Timeline

• Study First Submitted: 2024-08-14
• Study First Submitted QC: 2024-08-14
• Study First Posted: 2024-08-19
• Study Start: 2024-09-17
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-07
• Primary Completion: 2026-06
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 190

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/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.

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Exclusion Criteria

1. 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.
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.

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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 (35)

University Multiprofile Hospital for Active Treatment "Eurohospital Plovdiv"; 🇧🇬 Plovdiv, Bulgaria

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

The Second Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China

Medicover Munchen Ost MVZ; 🇩🇪 München, Bavaria, 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

Hokkaido University Hospital; 🇯🇵 Kita-Ku, Sapporo Hokkaido, Japan

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

Centrul Medical de Diagnostic si Tratament Ambulator NEOMED SRL; 🇷🇴 Brasov, Romania

FutureMeds DKF; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Spain

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung City, Taiwan

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

June DO, PC; 🇺🇸 Lansing, Michigan, United States

Juno DO, PC; 🇺🇸 Lansing, Michigan, United States

DJL Clinical Research PLLC; 🇺🇸 Charlotte, North Carolina, United States

Prolato Clinical Research Center (PCRC); 🇺🇸 Houston, Texas, United States

Prime Clinical Research - Mansfield; 🇺🇸 Mansfield, Texas, United States

Hospital of the University of Occupational and Environmental Health; 🇯🇵 Kitakyushu-shi, Fukuoka, Japan

Hospital of Shinkenko Clinic; 🇯🇵 Naha-city, Okinawa, Japan

Centro Reumatologico de Caguas; 🇵🇷 Caguas, Puerto Rico

Latin Clinical Trial Center; 🇵🇷 San Juan, Puerto Rico

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain