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ACTIVE NOT RECRUITING
NCT06559163
PHASE2

A Study of Obexelimab in Patients With Systemic Lupus Erythematosus

Sponsor: Zenas BioPharma (USA), LLC

View on ClinicalTrials.gov

Summary

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

Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Obexelimab in Patients With Systemic Lupus Erythematosus

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

190

Start Date

2024-09-17

Completion Date

2026-12

Last Updated

2026-08-18

Healthy Volunteers

No

Interventions

DRUG

Obexelimab

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

DRUG

Placebo

Placebo

Locations (110)

Onyx Clinical Research

Peoria, Arizona, United States

Sierra Pacific Arthritis and Rheumatology Centers

Fresno, California, United States

California Research Institute

Huntington Park, California, United States

University of California, San Diego

La Jolla, California, United States

University of California, Los Angeles

Los Angeles, California, United States

Solace Clinical Research

Tustin, California, United States

Yale University

New Haven, Connecticut, United States

Clinical Research of West Florida, Inc

Clearwater, Florida, United States

Clinical Research of West Florida, Inc.

Tampa, Florida, United States

Emory University

Atlanta, Georgia, United States

AARA Clinical Research - Chicago Arthritis & Regenerative Medicine

Chicago, Illinois, United States

Orthoillinois

Rockford, Illinois, United States

Willow Rheumatology and Wellness

Willowbrook, Illinois, United States

Accurate Clinical Research

Lake Charles, Louisiana, United States

Axon Clinical Research

Baltimore, Maryland, United States

UMass Chan Medical School

Worcester, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

Juno DO, PC

Lansing, Michigan, United States

Revive Research Institute - Sterling Heights

Sterling Heights, Michigan, United States

Velocity Clinical Research

St Louis, Missouri, United States

Hospital for Special Surgery

New York, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

DJL Clinical Research PLLC

Charlotte, North Carolina, United States

Cross Creek Medical Clinic

Fayetteville, North Carolina, United States

Onsite Clinical Solutions

Salisbury, North Carolina, United States

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, United States

Penn State - Hershey Medical Center

Hershey, Pennsylvania, United States

AARA Clinical Research - Rheumatology Specialty Center

Willow Grove, Pennsylvania, United States

Prolato Clinical Research Center (PCRC)

Houston, Texas, United States

Accurate Clinical Research

Houston, Texas, United States

Prime Clinical Research - Lewisville

Lewisville, Texas, United States

Prime Clinical Research - Mansfield

Mansfield, Texas, United States

UZ Leuven

Leuven, Belgium

CHU de Liege

Liège, Belgium

Medical Center Medtech Services EOOD

Haskovo, Bulgaria

University Multiprofile Hospital for Active Treatment "Eurohospital Plovdiv"

Plovdiv, Bulgaria

Diagnostic Consultative Center Convex EOOD

Sofia, Bulgaria

Richmond Clinical Trials

Richmond, British Columbia, Canada

Riverside Professional Centre

Sydney, Nova Scotia, Canada

Anhui Provincial Hospital (The First Affiliated Hospital of USTC)

Hefei, Anhui, China

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Shenzhen People's Hospital

Shenzhen, 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 Municipality, China

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

The Second Affiliated Hospital of Soochow University

Suzhou, China

Shanxi Bethune Hospital

Taiyuan, China

The First Affiliated Hospital of Ziamen University

Xiamen, China

Sjaellands Universitetshospital, Koge

Køge, Denmark

Medicover Munchen Ost MVZ

München, Bavaria, Germany

Uniklinik Koln

Cologne, Germany

Attikon University General Hospital

Chaïdári, Athens, Greece

General Hospital Asklepieio Voulas

Voula, Athens, Greece

University General Hospital of Heraklion

Heraklion, Greece

Olympion General Clinic

Pátrai, Greece

Kianous Stavros

Thessaloniki, Greece

General Hospital of Thessaloniki ''Hippokration''

Thessaloniki, Greece

Azienda Ospedaliero Universitaria di Ferrara

Ferrara, Italy

Ospedale Policlinico San Martino IRCCS

Genova, Italy

IRCCS Ospedale San Raffaele

Milan, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Policlinico Universitario Campus Biomedico Di Roma

Roma, Italy

Ospedale San Giovanni Bosco

Torino, Italy

Centro Ricerche Cliniche Di Verona S.r.l.

Verona, Italy

Hospital of Japan Community Health Care Organization Chukyo Hospital

Nagoya, Aichi-ken, Japan

Hospital of the University of Occupational and Environmental Health

Kitakyushu-shi, Fukuoka, Japan

Hospital of Shinkenko Clinic

Naha, Okinawa, Japan

Hokkaido University Hospital

Kita-ku, Sapporo Hokkaido, Japan

Juntendo University Hospital

Bunkyō City, 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

Centro de Estudios de Investigacion Basica Y Clinica SC

Guadalajara, Mexico

Centro de Investigacion y Tratamiento Reumatologico S.C.

Mexico City, Mexico

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubrian

Mexico City, Mexico

Oaxaca Site Management Organization

Oaxaca City, Mexico

Prywatna Praktyka Lekarska Prof Hab Med Pawel Hrycaj

Poznan, Greater Poland Voivodeship, Poland

Centrum Medyczne Plejady

Krakow, Lesser Poland Voivodeship, Poland

MICS Centrum Medyczne Warszawa

Warsaw, Masovian Voivodeship, Poland

MICS Centrum Medyczne Bydgoszcz

Bydgoszcz, Poland

Krakowskie Centrum Medyczne

Krakow, Poland

SOMED CR

Lodz, Poland

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

Lodz, Poland

Pracownia Badan Klinicznych Salus

Wroclaw, Poland

Hospital Egas Moniz

Lisbon, Portugal

ULS de Santa Maria, EPE - Hospital de Santa Maria

Lisbon, 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

Dr I Cantacuzino Clinical Hospital

Bucharest, Romania

FARMOVS

Bloemfontein, South Africa

Panorama Medical Centre

Cape Town, South Africa

Dr A Naidoo

Umhlanga, South Africa

Hospital Vall d'Hebron

Barcelona, Spain

FutureMeds DKF

Madrid, Spain

FuturMeds Madrid - Santa Elena

Madrid, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Virgen del Rocío

Seville, Spain

Buddhist Tzu Chi General Hospital

Chiayi City, Taiwan

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Chung Shan Medical University Hospital

Taichung, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Chang Gung Memorial Hospital

Taoyuan, Taiwan