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

Status: Recruiting
Location: See all (82) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Sierra Pacific Arthritis and Rheumatology Centers
RECRUITING
Fresno
California Research Institute
RECRUITING
Huntington Park
University of California, San Diego
RECRUITING
La Jolla
Florida
Clinical Research of West Florida, Inc
RECRUITING
Clearwater
Clinical Research of West Florida, Inc.
RECRUITING
Tampa
Georgia
Emory University
RECRUITING
Atlanta
Louisiana
Accurate Clinical Research
RECRUITING
Lake Charles
Michigan
Henry Ford Hospital
RECRUITING
Detroit
June DO, PC
RECRUITING
Lansing
Juno DO, PC
RECRUITING
Lansing
North Carolina
DJL Clinical Research PLLC
RECRUITING
Charlotte
Oklahoma
Oklahoma Medical Research Foundation
RECRUITING
Oklahoma City
Pennsylvania
Penn State - Hershey Medical Center
RECRUITING
Hershey
Texas
Accurate Clinical Research
RECRUITING
Houston
Prolato Clinical Research Center (PCRC)
RECRUITING
Houston
Prime Clinical Research - Mansfield
RECRUITING
Mansfield
Other Locations
Belgium
CHU de Liege
RECRUITING
Liège
Bulgaria
Medical Center Medtech Services EOOD
RECRUITING
Haskovo
University Multiprofile Hospital for Active Treatment Eurohospital Plovdiv
RECRUITING
Plovdiv
Canada
Richmond Clinical Trials
RECRUITING
Richmond
Riverside Professional Centre
RECRUITING
Sydney
China
Beijing Friendship Hospital, Capital Medical University
RECRUITING
Beijing
Peking University People's Hospital
RECRUITING
Beijing
The First Affiliated Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
Anhui Provincial Hospital (The First Affiliated Hospital of USTC)
RECRUITING
Hefei
The Second Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
The Second Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Lanzhou University Second Hospital
RECRUITING
Pudong
Renji Hospital, Shanghai Jiaotong University School of Medicine
RECRUITING
Shanghai
Shenzhen People's Hospital
RECRUITING
Shenzhen
The Second Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
The Second Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Shanxi Bethune Hospital
RECRUITING
Taiyuan
The First Affiliated Hospital of Ziamen University
RECRUITING
Xiamen
Denmark
Sjaellands Universitetshospital, Koge
RECRUITING
Køge
Germany
Uniklinik Koln
RECRUITING
Cologne
Medicover Munchen Ost MVZ
RECRUITING
München
Greece
Attikon University General Hospital
RECRUITING
Chaïdári
University General Hospital of Heraklion
RECRUITING
Heraklion
Olympion General Clinic
RECRUITING
Pátrai
General Hospital of Thessaloniki ''Hippokration''
RECRUITING
Thessaloniki
Kianous Stavros
RECRUITING
Thessaloniki
General Hospital Asklepieio Voulas
RECRUITING
Voula
Italy
Policlinico Universitario Campus Biomedico Di Roma
RECRUITING
Roma
Centro Ricerche Cliniche Di Verona S.r.l.
RECRUITING
Verona
Japan
Juntendo University Hospital
RECRUITING
Bunkyō City
Hokkaido University Hospital
RECRUITING
Kita-ku
Hospital of the University of Occupational and Environmental Health
RECRUITING
Kitakyushu-shi
Hospital of Japan Community Health Care Organization Chukyo Hospital
RECRUITING
Nagoya
Hospital of Shinkenko Clinic
RECRUITING
Naha
Mexico
PanAmerican Clinical Research
RECRUITING
Guadalajara
Eme Red Hospitalaria
RECRUITING
Mérida
Kohler and Milsten Research
RECRUITING
Mérida
Clinstile, S.A. de C.V.
RECRUITING
Mexico City
Oaxaca Site Management Organization
RECRUITING
Oaxaca City
Poland
MICS Centrum Medyczne Bydgoszcz
RECRUITING
Bydgoszcz
Centrum Medyczne Plejady
RECRUITING
Krakow
Krakowskie Centrum Medyczne
RECRUITING
Krakow
SOMED CR
RECRUITING
Lodz
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
RECRUITING
Lodz
Prywatna Praktyka Lekarska Prof Hab Med Pawel Hrycaj
RECRUITING
Poznan
MICS Centrum Medyczne Warszawa
RECRUITING
Warsaw
Pracownia Badan Klinicznych Salus
RECRUITING
Wroclaw
Portugal
Hospital Egas Moniz
RECRUITING
Lisbon
ULS de Santa Maria, EPE - Hospital de Santa Maria
RECRUITING
Lisbon
ULS da Arrábida, E.P.E. - Hospital de São Bernardo
RECRUITING
Setúbal
Puerto Rico
Centro Reumatologico de Caguas
RECRUITING
Caguas
Latin Clinical Trial Center
RECRUITING
San Juan
Romania
Centrul Medical de Diagnostic si Tratament Ambulator NEOMED SRL
RECRUITING
Brasov
Dr I Cantacuzino Clinical Hospital
RECRUITING
Bucharest
South Africa
FARMOVS
RECRUITING
Bloemfontein
Panorama Medical Centre
RECRUITING
Cape Town
Spain
FutureMeds DKF
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
Hospital Universitario Virgen del Rocío
RECRUITING
Seville
Taiwan
Buddhist Tzu Chi General Hospital
RECRUITING
Chiayi City
Kaohsiung Veterans General Hospital
RECRUITING
Kaohsiung City
Chung Shan Medical University Hospital
RECRUITING
Taichung
Taipei Medical University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Chang Gung Memorial Hospital
RECRUITING
Taoyuan District
Contact Information
Primary
Patient and Medical Information
clinicaltrialsinfo@zenasbio.com
833-269-4696
Time Frame
Start Date: 2024-09-17
Estimated Completion Date: 2026-09
Participants
Target number of participants: 190
Treatments
Experimental: Obexelimab
Obexelimab will be administered as a subcutaneous injection for 24 weeks.
Placebo_comparator: Placebo
Placebo will be administered as a subcutaneous injection for 24 weeks.
Related Therapeutic Areas
Sponsors
Leads: Zenas BioPharma (USA), LLC

This content was sourced from clinicaltrials.gov

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