A Study of Obexelimab in Patients With Systemic Lupus Erythematosus

NCT06559163 | Recruiting Phase 2 FDA Drug

• 1 other identifier: ZB012-02-001
• Study Type: interventional
• Target: 190
• Locations: 18 countries
• Sites: 82

Brief Summary

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

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic Lupus Erythematosus; SLE; Lupus

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measure

  Proportion of patients who achieve a response according to the BILAG-Based Composite Lupus Assessment (BICLA) Response

  24 weeks

Secondary Outcomes (1)

• Secondary Outcome Measures

  24 weeks

Other Outcomes (1)

• Additional Outcome Measures

  24 weeks

Study Arms (2)

Obexelimab

EXPERIMENTAL

Obexelimab will be administered as a subcutaneous injection for 24 weeks.

Drug: Obexelimab

Placebo

PLACEBO COMPARATOR

Placebo will be administered as a subcutaneous injection for 24 weeks.

Drug: Placebo

Interventions

Obexelimab DRUG

Obexelimab is a monoclonal antibody that simultaneously binds CD19 and FcyRllb, resulting in down regulation of B cell activity.

Obexelimab

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zenas BioPharma (USA), LLC: lead

Study Sites (82)

Sierra Pacific Arthritis and Rheumatology Centers

Fresno, California, 93710, United States

RECRUITING

California Research Institute

Huntington Park, California, 90255, United States

RECRUITING

University of California, San Diego

La Jolla, California, 92037, United States

RECRUITING

Clinical Research of West Florida, Inc

Clearwater, Florida, 33765, United States

RECRUITING

Clinical Research of West Florida, Inc.

Tampa, Florida, 33606, United States

RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Accurate Clinical Research

Lake Charles, Louisiana, 70605, United States

RECRUITING

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

June DO, PC

Lansing, Michigan, 48911, United States

RECRUITING

Juno DO, PC

Lansing, Michigan, 48911, United States

RECRUITING

DJL Clinical Research PLLC

Charlotte, North Carolina, 28211, United States

RECRUITING

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, 73104-5005, United States

RECRUITING

Penn State - Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

RECRUITING

Prolato Clinical Research Center (PCRC)

Houston, Texas, 77054, United States

RECRUITING

Accurate Clinical Research

Houston, Texas, 77089, United States

RECRUITING

Prime Clinical Research - Mansfield

Mansfield, Texas, 76063, United States

RECRUITING

CHU de Liege

Liège, Belgium

RECRUITING

Medical Center Medtech Services EOOD

Haskovo, 6304, Bulgaria

RECRUITING

University Multiprofile Hospital for Active Treatment "Eurohospital Plovdiv"

Plovdiv, 4004, Bulgaria

RECRUITING

Richmond Clinical Trials

Richmond, British Columbia, V6V 2L1, Canada

RECRUITING

Riverside Professional Centre

Sydney, Nova Scotia, B1S 3N1, Canada

RECRUITING

Anhui Provincial Hospital (The First Affiliated Hospital of USTC)

Hefei, Anhui, 230001, China

RECRUITING

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100044, China

RECRUITING

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

Shenzhen People's Hospital

Shenzhen, Guangdong, 518020, China

RECRUITING

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050005, China

RECRUITING

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangx, 330008, China

RECRUITING

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangx, 330008, China

RECRUITING

Lanzhou University Second Hospital

Pudong, Shanghai Municipality, 200127, China

RECRUITING

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200001, China

RECRUITING

The Second Affiliated Hospital of Soochow University

Suzhou, 215025, China

RECRUITING

Shanxi Bethune Hospital

Taiyuan, 030032, China

RECRUITING

The First Affiliated Hospital of Ziamen University

Xiamen, 361003, China

RECRUITING

Sjaellands Universitetshospital, Koge

Køge, 4600, Denmark

RECRUITING

Medicover Munchen Ost MVZ

München, Bavaria, 81667, Germany

RECRUITING

Uniklinik Koln

Cologne, Germany

RECRUITING

Attikon University General Hospital

Chaïdári, Athens, 12462, Greece

RECRUITING

General Hospital Asklepieio Voulas

Voula, Athens, 16673, Greece

RECRUITING

University General Hospital of Heraklion

Heraklion, 71500, Greece

RECRUITING

Olympion General Clinic

Pátrai, 26443, Greece

RECRUITING

Kianous Stavros

Thessaloniki, 54636, Greece

RECRUITING

General Hospital of Thessaloniki ''Hippokration''

Thessaloniki, 54642, Greece

RECRUITING

Policlinico Universitario Campus Biomedico Di Roma

Roma, 00128, Italy

RECRUITING

Centro Ricerche Cliniche Di Verona S.r.l.

Verona, 37134, Italy

RECRUITING

Hospital of Japan Community Health Care Organization Chukyo Hospital

Nagoya, Aichi-ken, 457-8510, Japan

RECRUITING

Hospital of the University of Occupational and Environmental Health

Kitakyushu-shi, Fukuoka, 807-8556, Japan

RECRUITING

Hospital of Shinkenko Clinic

Naha, Okinawa, 900-001, Japan

RECRUITING

Hokkaido University Hospital

Kita-ku, Sapporo Hokkaido, 060-8648, Japan

RECRUITING

Juntendo University Hospital

Bunkyō City, 113843, Japan

RECRUITING

Clinstile, S.A. de C.V.

Mexico City, Cuidad de Mexico, Mexico

RECRUITING

PanAmerican Clinical Research

Guadalajara, Jalisco, Mexico

RECRUITING

Eme Red Hospitalaria

Mérida, Yucatán, Mexico

RECRUITING

Kohler and Milsten Research

Mérida, Yucatán, Mexico

RECRUITING

Oaxaca Site Management Organization

Oaxaca City, 68000, Mexico

RECRUITING

Prywatna Praktyka Lekarska Prof Hab Med Pawel Hrycaj

Poznan, Greater Poland Voivodeship, 61-397, Poland

RECRUITING

Centrum Medyczne Plejady

Krakow, Lesser Poland Voivodeship, 30-363, Poland

RECRUITING

MICS Centrum Medyczne Warszawa

Warsaw, Masovian Voivodeship, 00-874, Poland

RECRUITING

MICS Centrum Medyczne Bydgoszcz

Bydgoszcz, 85090, Poland

RECRUITING

Krakowskie Centrum Medyczne

Krakow, 31501, Poland

RECRUITING

SOMED CR

Lodz, 05260, Poland

RECRUITING

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

Lodz, 90153, Poland

RECRUITING

Pracownia Badan Klinicznych Salus

Wroclaw, 50570, Poland

RECRUITING

Hospital Egas Moniz

Lisbon, 1349019, Portugal

RECRUITING

ULS de Santa Maria, EPE - Hospital de Santa Maria

Lisbon, 1649-035, Portugal

RECRUITING

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

Setúbal, 2910-446, Portugal

RECRUITING

Centro Reumatologico de Caguas

Caguas, Puerto Rico, 00725, Puerto Rico

RECRUITING

Latin Clinical Trial Center

San Juan, Puerto Rico, 00909, Puerto Rico

RECRUITING

Centrul Medical de Diagnostic si Tratament Ambulator NEOMED SRL

Brasov, 500283, Romania

RECRUITING

Dr I Cantacuzino Clinical Hospital

Bucharest, 030167, Romania

RECRUITING

FARMOVS

Bloemfontein, 9301, South Africa

RECRUITING

Panorama Medical Centre

Cape Town, 7500, South Africa

RECRUITING

FutureMeds DKF

Madrid, 28002, Spain

RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

RECRUITING

Buddhist Tzu Chi General Hospital

Chiayi City, 622, Taiwan

RECRUITING

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

RECRUITING

Chung Shan Medical University Hospital

Taichung, 402, Taiwan

RECRUITING

Taipei Medical University Hospital

Taipei, 110, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, 1121, Taiwan

RECRUITING

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Patient and Medical Information

CONTACT

833-269-4696; clinicaltrialsinfo@zenasbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 19, 2024
• Study Start: September 17, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-05

Locations

ZA (2); TW (6); US (16); BU (2); GR (6); DE (2); ME (5); ES (4); CN (13); BE (1); PR (2); PT (3); RO (2); IT (2); PL (8); CA (2); JP (5); DK (1)