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NCT06559163PHASE2Recruiting

A Study of Obexelimab in Patients With Systemic Lupus Erythematosus

Zenas BioPharma (USA), LLC

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

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. 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.

Interventions

DRUG

Obexelimab

DRUG

Placebo

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Conditions

Systemic Lupus Erythematosus

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