RecruitingPhase 2NCT06559163

A Study of Obexelimab in Patients With Systemic Lupus Erythematosus

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


Sponsor

Zenas BioPharma (USA), LLC

Enrollment

190 participants

Start Date

Sep 17, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Obexelimab and a drug called Placebo for people with systemic lupus erythematosus. The study is currently recruiting participants at 82 locations. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGObexelimab

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

DRUGPlacebo

Placebo


Locations(82)

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

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

Accurate Clinical Research

Lake Charles, Louisiana, United States

Henry Ford Hospital

Detroit, Michigan, 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

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, United States

Penn State - Hershey Medical Center

Hershey, Pennsylvania, United States

Prolato Clinical Research Center (PCRC)

Houston, Texas, United States

Accurate Clinical Research

Houston, Texas, United States

Prime Clinical Research - Mansfield

Mansfield, Texas, United States

CHU de Liege

Liège, Belgium

Medical Center Medtech Services EOOD

Haskovo, Bulgaria

University Multiprofile Hospital for Active Treatment "Eurohospital Plovdiv"

Plovdiv, 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

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

Policlinico Universitario Campus Biomedico Di Roma

Roma, 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

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, Puerto Rico

Latin Clinical Trial Center

San Juan, Puerto Rico, 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

FutureMeds DKF

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

View Full Details on ClinicalTrials.gov

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NCT06559163


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