Phase
Condition
Systemic Lupus Erythematosus
Cutaneous Lupus Erythematosus
Musculoskeletal Diseases
Treatment
Obexelimab
Placebo
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Males and females, ≥ 18 to ≤ 70 years of age
Diagnosed with SLE at least 24 weeks prior to screening and meets the 2019 EULAR/ACRclassification criteria.
Patient has all 3 of the following based on features active on the day of thevisits:
hSLEDAI ≥ 6 and clinical hSLEDAI ≥ 4 at screening, and clinical hSLEDAI ≥ 4 atDay 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 issufficient disease activity to warrant enrollment into a clinical study with aninvestigational agent.
Patients must be treated with one or more of the following background nonbiologiclupus standard of care therapies: oral corticosteroid, antimalarial, and/orimmunosuppressant.
Exclusion
Exclusion Criteria:
Active lupus nephritis for which, in the opinion of the investigator or the centraladjudicator, current medications are insufficient for patient's safety or additionaltherapy that is not permitted in the protocol is needed.
A history of thrombosis or embolism in the previous 6 months before the Screeningvisit, or previous 12 months associated with antiphospholipid syndrome (APS) oranother relevant hypercoagulable state.
Any active skin conditions other than cutaneous lupus erythematosus (CLE) that mayinterfere 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 signsand symptoms in the opinion of the investigator or central adjudicator.
Study Design
Study Description
Connect with a study center
CHU de Liege
Liege,
BelgiumActive - Recruiting
University Multiprofile Hospital for Active Treatment "Eurohospital Plovdiv"
Plovdiv, 4004
BulgariaActive - Recruiting
Richmond Clinical Trials
Richmond, British Columbia V6V 2L1
CanadaActive - Recruiting
Riverside Professional Centre
Sydney, Nova Scotia B1S 3N1
CanadaActive - Recruiting
Anhui Provincial Hospital (The First Affiliated Hospital of USTC)
Hefei, Anhui 230001
ChinaActive - Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing 100044
ChinaActive - Recruiting
Peking University People's Hospital
Beijing, Beijing 100044
ChinaActive - Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
ChinaActive - Recruiting
Shenzhen People's Hospital
Shenzhen, Guangdong 518020
ChinaActive - Recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei 050005
ChinaActive - Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangx 330008
ChinaActive - Recruiting
Lanzhou University Second Hospital
Pudong, Shanghai 200127
ChinaActive - Recruiting
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai 200001
ChinaActive - Recruiting
Medicover Munchen Ost MVZ
München, Bavaria 81667
GermanyActive - Recruiting
Uniklinik Koln
Cologne,
GermanyActive - Recruiting
Attikon University General Hospital
Chaidari, Athens 12462
GreeceActive - Recruiting
General Hospital Asklepieio Voulas
Voula, Athens 16673
GreeceActive - Recruiting
General Hospital of Thessaloniki ''Hippokration''
Thessaloniki, 54642
GreeceActive - Recruiting
Centro Ricerche Cliniche Di Verona S.r.l.
Verona, 37134
ItalyActive - Recruiting
Hospital of Japan Community Health Care Organization Chukyo Hospital
Nagoya-shi, Aichi 457-8510
JapanActive - Recruiting
Hospital of the University of Occupational and Environmental Health
Kitakyushu-shi, Fukuoka 807-8556
JapanActive - Recruiting
Hospital of Shinkenko Clinic
Naha-city, Okinawa 900-001
JapanActive - Recruiting
Hokkaido University Hospital
Kita-Ku, Sapporo Hokkaido 060-8648
JapanActive - Recruiting
Clinstile, S.A. de C.V.
Mexico City, Cuidad de Mexico
MexicoActive - Recruiting
PanAmerican Clinical Research
Guadalajara, Jalisco
MexicoActive - Recruiting
Eme Red Hospitalaria
Merida, Yucatán
MexicoActive - Recruiting
Kohler and Milsten Research
Merida, Yucatán
MexicoActive - Recruiting
Centrum Medyczne Plejady
Krakow, Malopolskie 30-363
PolandActive - Recruiting
MICS Centrum Medyczne Warszawa
Warsaw, Mazowieckie 00-874
PolandActive - Recruiting
Prywatna Praktyka Lekarska Prof Hab Med Pawel Hrycaj
Poznan, Wielkopolskie 61-397
PolandActive - Recruiting
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, 90153
PolandActive - Recruiting
ULS de Santa Maria, EPE - Hospital de Santa Maria
Lisboa, 1649-035
PortugalActive - Recruiting
ULS da Arrábida, E.P.E. - Hospital de São Bernardo
Setúbal, 2910-446
PortugalActive - Recruiting
Centro Reumatologico de Caguas
Caguas, 00725
Puerto RicoActive - Recruiting
Latin Clinical Trial Center
San Juan, 00909
Puerto RicoActive - Recruiting
Centrul Medical de Diagnostic si Tratament Ambulator NEOMED SRL
Brasov, 500283
RomaniaActive - Recruiting
FutureMeds DKF
Madrid, 28002
SpainActive - Recruiting
Hospital Universitario La Paz
Madrid, 28046
SpainActive - Recruiting
Hospital Universitario Ramón y Cajal
Madrid, 28034
SpainActive - Recruiting
Hospital Universitario Virgen del Rocío
Sevilla, 41013
SpainActive - Recruiting
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362
TaiwanActive - Recruiting
Sierra Pacific Arthritis and Rheumatology Centers
Fresno, California 93710
United StatesActive - Recruiting
University of California, San Diego
La Jolla, California 92037
United StatesActive - Recruiting
Clinical Research of West Florida, Inc
Clearwater, Florida 33765
United StatesActive - Recruiting
Clinical Research of West Florida, Inc.
Tampa, Florida 33606
United StatesActive - Recruiting
Accurate Clinical Research
Lake Charles, Louisiana 70605
United StatesActive - Recruiting
Henry Ford Hospital
Detroit, Michigan 48202
United StatesActive - Recruiting
June DO, PC
Lansing, Michigan 48911
United StatesActive - Recruiting
Juno DO, PC
Lansing, Michigan 48911
United StatesActive - Recruiting
DJL Clinical Research PLLC
Charlotte, North Carolina 28211
United StatesActive - Recruiting
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma 73104-5005
United StatesActive - Recruiting
Penn State - Hershey Medical Center
Hershey, Pennsylvania 17033
United StatesActive - Recruiting
Accurate Clinical Research
Houston, Texas 77089
United StatesActive - Recruiting
Prolato Clinical Research Center (PCRC)
Houston, Texas 77054
United StatesActive - Recruiting
Prime Clinical Research - Mansfield
Mansfield, Texas 76063
United StatesActive - Recruiting
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