Phase
Condition
Systemic Lupus Erythematosus
Bone Diseases
Cutaneous Lupus Erythematosus
Treatment
Placebo SC
SAR441344 SC
Placebo IV
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosis of SLE for at least 6 months prior to screening by fulfilling the RevisedCriteria for Classification of SLE according to the 1997 Update of the 1982 ACRcriteria
Positive antinuclear antibody (ANA) (titer ≥1:80) during screening
Positivity for at least one serological characteristic
Total hSELENA-SLEDAI score ≥6 (including points attributed from arthritis and rash)during screening and at least 4 points from clinical features at randomization asconfirmed by a Sponsor-selected independent reviewer(s)
At least 1 BILAG A score or 2 BILAG B scores during screening as confirmed by aSponsor-selected independent reviewer(s)
Receiving at least one of the standard of care (SOC) for SLE (combination ispossible)
Body weight within 45 kg to 120 kg (inclusive) at screening
Contraceptive use by men or women should be consistent with local regulationsregarding the methods of contraception for those participating in clinical studies.
Exclusion
Exclusion Criteria:
Primary diagnosis of a rheumatic disease besides SLE or an inflammatory joint orskin disease other than SLE that could confound the disease activity assessments
Active and severe lupus nephritis
Active severe or unstable neuropsychiatric SLE including but not limited toseizures, psychosis, acute confusional state, transverse myelitis, central nervoussystem vasculitis and optic neuritis
Known or suspected drug-induced lupus
History, clinical evidence, suspicion or significant risk, for thromboembolicevents, as well as myocardial infarction, stroke, and/or antiphospholipid syndromeand any participants requiring antithrombotic treatment
History or current hypogammaglobulinemia
Serious systemic viral, bacterial or fungal infection
Participants with a history of invasive opportunistic infections, such as, but notlimited to histoplasmosis, listeriosis, coccidioidomycosis, candidiasis,pneumocystis jirovecii, and aspergillosis, regardless of resolution
Evidence of active or untreated latent tuberculosis as documented by medical history (eg, chest Xrays) and examination, and tuberculosis testing
High dose of steroids, or a change in dose within 4 weeks prior to randomization
High dose of antimalarial, or a change in dose within 12 weeks prior torandomization
High dose of immunosuppressants or a change in dose within 12 weeks prior torandomization
Use of cyclophosphamide within 3 months prior to screening
Previous parenteral (IV), intramuscular (IM), or intra-articular steroidadministration within 4 weeks prior to randomization
Participants likely to require multiple courses of oral corticosteroid (OCS) duringthe study for chronic diseases other than SLE
Administration of any live (attenuated) vaccine within 3 months prior torandomization (eg, varicella zoster vaccine, oral polio, rabies)
Administration of any non-live vaccine (eg, seasonal influenza, COVID-19) within 4weeks prior to randomization
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Design
Connect with a study center
Investigational Site Number : 0320008
Berazategui, Buenos Aires 1886
ArgentinaCompleted
Investigational Site Number :0320008
Berazategui, Buenos Aires CP 1884
ArgentinaActive - Recruiting
Investigational Site Number : 0320001
Caba, Buenos Aires C1111
ArgentinaCompleted
Investigational Site Number : 0320002
Caba, Buenos Aires 1430
ArgentinaCompleted
Investigational Site Number : 0320006
Caba, Buenos Aires C1023AAB
ArgentinaCompleted
Investigational Site Number :0320001
Caba, Buenos Aires C1111
ArgentinaActive - Recruiting
Investigational Site Number :0320002
Caba, Buenos Aires 1430
ArgentinaActive - Recruiting
Investigational Site Number :0320006
Caba, Buenos Aires C1023AAB
ArgentinaActive - Recruiting
Investigational Site Number : 0320001
Buenos Aires, 1111
ArgentinaCompleted
Investigational Site Number : 0320002
Buenos Aires, 1430
ArgentinaCompleted
Investigational Site Number : 0320004
Buenos Aires, 1121
ArgentinaCompleted
Investigational Site Number : 0320006
Buenos Aires, 1023
ArgentinaCompleted
Investigational Site Number :0320004
Buenos Aires, C1121ABE
ArgentinaActive - Recruiting
Investigational Site Number : 0320004
Caba, C1121ABE
ArgentinaSite Not Available
Investigational Site Number : 0320004
Ciudad Autonoma Bs As, C1121ABE
ArgentinaSite Not Available
Investigational Site Number : 0320003
San Miguel de Tucuman, 4000
ArgentinaSite Not Available
Investigational Site Number :0320003
San Miguel de Tucuman, T4000AXL
ArgentinaActive - Recruiting
Investigational Site Number : 0320003
San Miguel de Tucumán, 4000
ArgentinaCompleted
CETI - Centro de Estudos em Terapias Inovadoras Site Number : 0760002
Curitiba, Paraná 80060-240
BrazilCompleted
CETI - Centro de Estudos em Terapias Inovadoras- Site Number : 0760002
Curitiba, Paraná 80060-240
BrazilCompleted
Centro de Estudos em Terapias Inovadoras- Site Number : 0760002
Curitiba, Paraná 80030-110
BrazilCompleted
Investigational Site Number :0760002
Curitiba, Paraná 80060-240
BrazilActive - Recruiting
Investigational Site Number :0760001
Porto Alegre, Rio Grande Do Sul 90480-000
BrazilActive - Recruiting
LMK Servicos Medicos Ss Site Number : 0760001
Porto Alegre, Rio Grande Do Sul 90480-000
BrazilCompleted
LMK Servicos Medicos Ss- Site Number : 0760001
Porto Alegre, Rio Grande Do Sul 90480-000
BrazilCompleted
LMK Servicos Medicos- Site Number : 0760001
Porto Alegre, Rio Grande Do Sul 90480-000
BrazilCompleted
Centro Integrado de Pesquisa Site Number : 0760006
Sao Jose do Rio Preto, São Paulo 15090-000
BrazilCompleted
Centro Integrado de Pesquisa- Site Number : 0760006
Sao Jose do Rio Preto, São Paulo 15090-000
BrazilSite Not Available
CEPIC - Centro Paulista De Investigacao Clinica Site Number : 0760004
Sao Paulo, São Paulo 04266-010
BrazilCompleted
CEPIC - Centro Paulista De Investigacao Clinica- Site Number : 0760004
Sao Paulo, São Paulo 04266-010
BrazilCompleted
Investigational Site Number :0760004
Sao Paulo, São Paulo 04266-010
BrazilActive - Recruiting
Investigational Site Number :0760007
Sao Paulo, São Paulo 04014-002
BrazilActive - Recruiting
Nucleo de Pesquisa Clinica e Ensino da Rede Sao Camilo Site Number : 0760007
Sao Paulo, São Paulo 04014-002
BrazilCompleted
Nucleo de Pesquisa Clinica e Ensino da Rede Sao Camilo- Site Number : 0760007
Sao Paulo, São Paulo 04014-002
BrazilSite Not Available
Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760006
São José Do Rio Preto, São Paulo 15090-000
BrazilCompleted
Investigational Site Number :0760006
São José do Rio Preto, São Paulo 15090-000
BrazilSite Not Available
Centro Paulista de Investigaçăo Clínica - CEPIC- Site Number : 0760004
São Paulo, 04265-000
BrazilCompleted
Núcleo de Pesquisa Clínica da Rede São Camilo- Site Number : 0760007
São Paulo, 04014-002
BrazilCompleted
Investigational Site Number : 1520002
Osorno, Los Lagos 5311092
ChileCompleted
Investigational Site Number :1520002
Osorno, Los Lagos 5311092
ChileActive - Recruiting
Investigational Site Number : 1520003
Talca, Maule 3465584
ChileCompleted
Investigational Site Number :1520003
Talca, Maule
ChileActive - Recruiting
Investigational Site Number : 1520001
Santiago, Reg Metropolitana De Santiago 7640881
ChileCompleted
Investigational Site Number : 1520004
Santiago, Reg Metropolitana De Santiago 7510047
ChileCompleted
Investigational Site Number :1520001
Santiago, Reg Metropolitana De Santiago 7640881
ChileActive - Recruiting
Investigational Site Number :1520004
Santiago, Reg Metropolitana De Santiago
ChileActive - Recruiting
Investigational Site Number : 2680001
Tbilisi, 0131
GeorgiaActive - Recruiting
Investigational Site Number : 2680002
Tbilisi, 0186
GeorgiaActive - Recruiting
Investigational Site Number : 2680003
Tbilisi, 0159
GeorgiaActive - Recruiting
Investigational Site Number : 2680004
Tbilisi, 0114
GeorgiaActive - Recruiting
Investigational Site Number : 3000001
Athens, 124 62
GreeceActive - Recruiting
Investigational Site Number : 3000004
Athens, 115 27
GreeceActive - Recruiting
Investigational Site Number :3000001
Athens, 12462
GreeceActive - Recruiting
Investigational Site Number :3000004
Athens, 11527
GreeceActive - Recruiting
Investigational Site Number : 3000003
Heraklion, 711 10
GreeceActive - Recruiting
Investigational Site Number :3000003
Heraklion, 71110
GreeceActive - Recruiting
Investigational Site Number : 3000005
Larissa, 415 00
GreeceActive - Recruiting
Investigational Site Number : 3000002
Thassaloniki, 546 36
GreeceSite Not Available
Investigational Site Number :3000002
Thassaloniki,
GreeceActive - Recruiting
Investigational Site Number : 3000002
Thessaloniki, 546 36
GreeceActive - Recruiting
Investigational Site Number :3000002
Thessaloníki,
GreeceSite Not Available
Investigational Site Number : 3480002
Gyula, 5700
HungaryActive - Recruiting
Investigational Site Number :3480002
Gyula, 5700
HungaryActive - Recruiting
Investigational Site Number : 3480003
Székesfehérvár, 8000
HungaryActive - Recruiting
Investigational Site Number :3480003
Székesfehérvár, 8000
HungaryActive - Recruiting
AOU Luigi Vanvitelli-Site Number : 3800004
Caserta, Campania 81100
ItalyActive - Recruiting
AOU Luigi Vanvitelli-Site Number : 3800004
Napoli, Campania 80138
ItalySite Not Available
Fondazione Policlinico Universitario Agostino Gemelli-Site Number : 3800002
Roma, Lazio 00168
ItalyActive - Recruiting
Investigational Site Number : 3800002
Roma, Lazio 00168
ItalyActive - Recruiting
Investigational Site Number :3800002
Roma, Lazio 00168
ItalyActive - Recruiting
IRCCS Ospedale San Raffaele-Site Number : 3800001
Milan, Lombardia 20132
ItalyActive - Recruiting
Investigational Site Number : 3800003
Firenze, 50134
ItalySite Not Available
Investigational Site Number :3800003
Firenze, 50134
ItalyActive - Recruiting
Investigational Site Number : 3800001
Milano, 20132
ItalySite Not Available
Investigational Site Number :3800001
Milano, 20132
ItalyActive - Recruiting
Investigational Site Number : 3800004
Napoli, 80138
ItalyActive - Recruiting
Investigational Site Number :3800004
Napoli, 80138
ItalyActive - Recruiting
Investigational Site Number : 4800001
Quatre Bornes, 72218
MauritiusSite Not Available
Investigational Site Number :4800001
Quatre Bornes, 72218
MauritiusActive - Recruiting
Investigational Site Number : 4800001
Vacoas-phoenix, 72218
MauritiusCompleted
Investigational Site Number : 4840009
Benito Juárez, Ciudad De Mexico 03100
MexicoSite Not Available
Investigational Site Number : 4840004
Mexico, Ciudad De Mexico 06700
MexicoSite Not Available
Investigational Site Number : 4840004
Mexico City, Ciudad De Mexico 06700
MexicoCompleted
Investigational Site Number : 4840009
Mexico City, Ciudad De Mexico 03100
MexicoCompleted
Investigational Site Number : 4840009
\\Ciudad de México, Ciudad De Mexico 03100
MexicoSite Not Available
Investigational Site Number :4840009
\\Ciudad de México, Ciudad De Mexico 03100
MexicoActive - Recruiting
Investigational Site Number : 4840002
Benito Juarez, Ciudad De México 03100
MexicoSite Not Available
Investigational Site Number : 4840007
México, D.F., México 11850
MexicoSite Not Available
Investigational Site Number : 4840001
Monterrey, Nuevo León 64460
MexicoCompleted
Investigational Site Number :4840001
Monterrey, Nuevo León 64460
MexicoActive - Recruiting
Investigational Site Number :4840002
Benito Juarez, 03100
MexicoSite Not Available
Investigational Site Number : 4840006
Chihuahua, 31000
MexicoCompleted
Investigational Site Number : 4840011
Chihuahua, 31210
MexicoCompleted
Investigational Site Number :4840006
Chihuahua, 31020
MexicoActive - Recruiting
Investigational Site Number :4840004
Mexico, 06700
MexicoActive - Recruiting
Investigational Site Number : 4840007
Mexico City, 11850
MexicoCompleted
Investigational Site Number : 4840005
Mérida, 97070
MexicoCompleted
Investigational Site Number : 4840008
Veracruz, 91910
MexicoCompleted
Investigational Site Number :4840008
Veracruz, 91910
MexicoActive - Recruiting
Investigational Site Number : 4840005
Yucatan, 97070
MexicoSite Not Available
Investigational Site Number :4840005
Yucatan, 97070
MexicoActive - Recruiting
GCM Medical Group - San Juan - Calle Jose Marti- Site Number : 8400011
San Juan, 00917
Puerto RicoActive - Recruiting
GCM Medical Group Site Number : 8400011
San Juan, 00917
Puerto RicoActive - Recruiting
GCM Medical Group- Site Number : 8400011
San Juan, 00917
Puerto RicoActive - Recruiting
Investigational Site Number : 6430002
Moscow, 111539
Russian FederationCompleted
Investigational Site Number :6430002
Moscow, 111539
Russian FederationCompleted
Investigational Site Number :6430003
Ryazan, 390026
Russian FederationSite Not Available
Investigational Site Number :6430006
Saint-Petersburg, 192242
Russian FederationSite Not Available
Investigational Site Number : 7240002
Barcelona / Sabadell, Castilla Y León 08208
SpainSite Not Available
Investigational Site Number : 7240002
Sabadell, Castilla Y León 08208
SpainActive - Recruiting
Investigational Site Number :7240002
Barcelona / Sabadell, Catalunya [Cataluña] 08208
SpainActive - Recruiting
Investigational Site Number : 7240001
Madrid, Madrid, Comunidad De 28046
SpainActive - Recruiting
Investigational Site Number :7240001
Madrid, Madrid, Comunidad De 28046
SpainActive - Recruiting
Investigational Site Number :7240002
Barcelona, 08208
SpainSite Not Available
Investigational Site Number : 7240005
Valencia, 46014
SpainActive - Recruiting
Investigational Site Number : 7240004
Valladolid, 47012
SpainActive - Recruiting
Investigational Site Number : 7560001
St. Gallen, 9007
SwitzerlandActive - Recruiting
Investigational Site Number : 7920001
Ankara, 06230
TurkeyActive - Recruiting
Investigational Site Number : 7920003
Ankara, 06800
TurkeyActive - Recruiting
Investigational Site Number :7920001
Ankara, 06100
TurkeySite Not Available
Investigational Site Number : 7920002
Denizli, 20070
TurkeyActive - Recruiting
Investigational Site Number :7920002
Denizli, 20070
TurkeySite Not Available
Investigational Site Number : 8040001
Kyiv, 02125
UkraineCompleted
Investigational Site Number : 8040002
Kyiv, 02081
UkraineActive - Recruiting
Investigational Site Number : 8040003
Kyiv, 04050
UkraineActive - Recruiting
Investigational Site Number : 8040006
Kyiv, 02091
UkraineSite Not Available
Investigational Site Number :8040001
Kyiv, 02125
UkraineCompleted
Investigational Site Number :8040006
Kyiv, 02091
UkraineSite Not Available
Investigational Site Number : 8040005
Poltava, 36011
UkraineCompleted
Investigational Site Number :8040005
Poltava, 36011
UkraineCompleted
Investigational Site Number :8040004
Vinnytsia, 21001
UkraineSite Not Available
Accel Research Sites Network - Birmingham- Site Number : 8400003
Birmingham, Alabama 35216
United StatesActive - Recruiting
Achieve Clinical Research Site Number : 8400003
Birmingham, Alabama 35216
United StatesActive - Recruiting
Achieve Clinical Research- Site Number : 8400003
Birmingham, Alabama 35216
United StatesActive - Recruiting
Achieve Clinical Research-Site Number:8400003
Birmingham, Alabama 35216
United StatesActive - Recruiting
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler- Site Number : 8400026
Chandler, Arizona 85225
United StatesActive - Recruiting
Arizona Arthritis & Rheumatology Associates Site Number : 8400026
Chandler, Arizona 85225
United StatesActive - Recruiting
Arizona Arthritis & Rheumatology Associates- Site Number : 8400026
Chandler, Arizona 85225
United StatesActive - Recruiting
Arizona Arthritis & Rheumatology Associates - South Vineyard Avenue- Site Number : 8400022
Mesa, Arizona 85210
United StatesActive - Recruiting
Arizona Arthritis & Rheumatology Associates Site Number : 8400022
Mesa, Arizona 85210
United StatesActive - Recruiting
Arizona Arthritis & Rheumatology Associates- Site Number : 8400022
Mesa, Arizona 85210
United StatesActive - Recruiting
Arizona Arthritis & Rheumatology Associates Site Number : 8400027
Sun City, Arizona 85351
United StatesActive - Recruiting
Arizona Arthritis & Rheumatology Associates- Site Number : 8400027
Sun City, Arizona 85351
United StatesActive - Recruiting
Arizona Arthritis & Rheumatology Research - Sun City- Site Number : 8400027
Sun City, Arizona 85351
United StatesActive - Recruiting
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast- Site Number : 8400023
Tucson, Arizona 85748
United StatesActive - Recruiting
Arizona Arthritis & Rheumatology Associates Site Number : 8400023
Tucson, Arizona 85748
United StatesActive - Recruiting
Arizona Arthritis & Rheumatology Associates- Site Number : 8400023
Tucson, Arizona 85748
United StatesActive - Recruiting
Saint John's Physician Partners Site Number : 8400015
Santa Monica, California 90404
United StatesActive - Recruiting
Saint John's Physician Partners- Site Number : 8400015
Santa Monica, California 90404
United StatesActive - Recruiting
Millennium Clinical Trials - Simi Valley- Site Number : 8400004
Simi Valley, California 93065
United StatesActive - Recruiting
Millennium Clinical Trials Site Number : 8400004
Simi Valley, California 93065
United StatesActive - Recruiting
Millennium Clinical Trials- Site Number : 8400004
Simi Valley, California 93065
United StatesActive - Recruiting
Millennium Clinical Trials Site Number : 8400004
Thousand Oaks, California 91360
United StatesSite Not Available
Millennium Clinical Trials-Site Number:8400004
Thousand Oaks, California 91360
United StatesActive - Recruiting
Omega Research - Site Number : 8400002
DeBary, Florida 32713
United StatesActive - Recruiting
Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400002
DeBary, Florida 32713
United StatesActive - Recruiting
Omega Research Site Number : 8400002
DeBary, Florida 32713
United StatesActive - Recruiting
Omega Research-Site Number:8400002
DeBary, Florida 32713
United StatesActive - Recruiting
Integral Rheumatology and Immunology Specialists- Site Number : 8400014
Plantation, Florida 33324
United StatesActive - Recruiting
Iris Rheumatology Site Number : 8400014
Plantation, Florida 33324
United StatesActive - Recruiting
Iris Rheumatology- Site Number : 8400014
Plantation, Florida 33324
United StatesActive - Recruiting
Infigo Clinical Research Site Number : 8400016
Sanford, Florida 32771
United StatesActive - Recruiting
Infigo Clinical Research- Site Number : 8400016
Sanford, Florida 32771
United StatesActive - Recruiting
Sahni Rheumatology & Therapy, PC Site Number : 8400021
West Long Branch, New Jersey 07764
United StatesActive - Recruiting
Sahni Rheumatology & Therapy, PC- Site Number : 8400021
West Long Branch, New Jersey 07764
United StatesActive - Recruiting
Sahni Rheumatology & Therapy- Site Number : 8400021
West Long Branch, New Jersey 07764
United StatesActive - Recruiting
Inspire Santa Fe Medical Group Site Number : 8400019
Santa Fe, New Mexico 87505
United StatesActive - Recruiting
Inspire Santa Fe Medical Group- Site Number : 8400019
Santa Fe, New Mexico 87505
United StatesActive - Recruiting
Columbia University Irving Medical Center- Site Number : 8400009
New York, New York 10032
United StatesActive - Recruiting
Columbia University Medical Center Site Number : 8400009
New York, New York 10032-3725
United StatesActive - Recruiting
Columbia University Medical Center- Site Number : 8400009
New York, New York 10032-3725
United StatesActive - Recruiting
Columbia University Medical Center-Site Number:8400009
New York, New York 10032
United StatesActive - Recruiting
SUNY Upstate Medical University-Site Number:8400006
Syracuse, New York 13210
United StatesSite Not Available
RAO - Rheumatology Associates of Oklahoma- Site Number : 8400013
Oklahoma City, Oklahoma 73116
United StatesActive - Recruiting
RAO Research, LLC Site Number : 8400013
Oklahoma City, Oklahoma 73116
United StatesActive - Recruiting
RAO Research, LLC- Site Number : 8400013
Oklahoma City, Oklahoma 73116
United StatesActive - Recruiting
Private Practice - Dr. Ramesh C. Gupta I- Site Number : 8400008
Memphis, Tennessee 38119
United StatesCompleted
Ramesh C. Gupta, M.D. Site Number : 8400008
Memphis, Tennessee 38119
United StatesCompleted
Ramesh C. Gupta, M.D.- Site Number : 8400008
Memphis, Tennessee 38119
United StatesCompleted
Ramesh C. Gupta, M.D.-Site Number:8400008
Memphis, Tennessee 38119
United StatesActive - Recruiting
Tekton Research - West Gate- Site Number : 8400001
Austin, Texas 78745
United StatesCompleted
Tekton Research, Inc - Site Number : 8400001
Austin, Texas 78745
United StatesCompleted
Tekton Research, Inc Site Number : 8400001
Austin, Texas 78745
United StatesCompleted
Tekton Research, Inc-Site Number:8400001
Austin, Texas 78745
United StatesActive - Recruiting
Precision Comprehensive Clinical Research Solutions - Colleyville- Site Number : 8400017
Colleyville, Texas 76034
United StatesActive - Recruiting
Precision Comprehensive Clinical Research Solutions/Heritage Rheumatology Site Number : 8400017
Colleyville, Texas 76034
United StatesActive - Recruiting
Precision Comprehensive Clinical Research Solutions/Heritage Rheumatology- Site Number : 8400017
Colleyville, Texas 76034
United StatesActive - Recruiting
Lone Start Arthritis & Rheumatology Associates Site Number : 8400025
Fort Worth, Texas 76109
United StatesActive - Recruiting
Lone Start Arthritis & Rheumatology Associates- Site Number : 8400025
Fort Worth, Texas 76109
United StatesActive - Recruiting
Prolato Clinical Research Center Site Number : 8400005
Houston, Texas 77054
United StatesActive - Recruiting
Prolato Clinical Research Center- Site Number : 8400005
Houston, Texas 77054
United StatesActive - Recruiting
Prolato Clinical Research Center-Site Number:8400005
Houston, Texas 77054
United StatesActive - Recruiting
AARA Clinical Research - Lone Star Arthritis & Rheumatology Associates - Irving- Site Number : 8400024
Irving, Texas 75039
United StatesActive - Recruiting
Lone Star Arthritis & Rheumatology Associates Site Number : 8400024
Irving, Texas 75039
United StatesActive - Recruiting
Lone Star Arthritis & Rheumatology Associates- Site Number : 8400024
Irving, Texas 75039
United StatesActive - Recruiting
West Texas Clinical Research Site Number : 8400018
Lubbock, Texas 79424
United StatesActive - Recruiting
West Texas Clinical Research- Site Number : 8400018
Lubbock, Texas 79410
United StatesActive - Recruiting
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