Efficacy and Safety of Frexalimab (SAR441344) in the Treatment of Systemic Lupus Erythematosus
NCT ID: NCT05039840
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
116 participants
INTERVENTIONAL
2021-11-10
2026-10-02
Brief Summary
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* Study duration: 36 weeks
* Treatment duration: 24 weeks
* Visit frequency: every 2 weeks
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Frexalimab
Frexalimab intravenous (IV) loading dose followed by subcutaneous (SC) doses, 24 weeks
SAR441344 IV
Pharmaceutical form: solution Route of administration: Intravenous infusion
SAR441344 SC
Pharmaceutical form: solution Route of administration: subcutaneous injection
Placebo
Placebo IV loading dose followed by SC, 24 weeks
Placebo IV
Pharmaceutical form: solution Route of administration: Intravenous infusion
Placebo SC
Pharmaceutical form: solution Route of administration: subcutaneous injection
Interventions
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SAR441344 IV
Pharmaceutical form: solution Route of administration: Intravenous infusion
SAR441344 SC
Pharmaceutical form: solution Route of administration: subcutaneous injection
Placebo IV
Pharmaceutical form: solution Route of administration: Intravenous infusion
Placebo SC
Pharmaceutical form: solution Route of administration: subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
* 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 as confirmed by a Sponsor-selected independent reviewer(s)
* At least 1 BILAG A score or 2 BILAG B scores during screening as confirmed by a Sponsor-selected independent reviewer(s)
* Receiving at least one of the standard of care (SOC) for SLE (combination is possible)
* Body weight within 45 kg to 120 kg (inclusive) at screening
* Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion Criteria
* Active and severe lupus nephritis
* Active severe or unstable neuropsychiatric SLE including but not limited to seizures, psychosis, acute confusional state, transverse myelitis, central nervous system vasculitis and optic neuritis
* Known or suspected drug-induced lupus
* History, clinical evidence, suspicion or significant risk, for thromboembolic events, as well as myocardial infarction, stroke, and/or antiphospholipid syndrome and 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 not limited 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 to randomization
* High dose of immunosuppressants or a change in dose within 12 weeks prior to randomization
* Use of cyclophosphamide within 3 months prior to screening
* Previous parenteral (IV), intramuscular (IM), or intra-articular steroid administration within 4 weeks prior to randomization
* Participants likely to require multiple courses of oral corticosteroid (OCS) during the study for chronic diseases other than SLE
* Administration of any live (attenuated) vaccine within 3 months prior to randomization (eg, varicella zoster vaccine, oral polio, rabies)
* Administration of any non-live vaccine (eg, seasonal influenza, COVID-19) within 4 weeks prior to randomization
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
18 Years
70 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Accel Research Sites Network - Vestavia Hills- Site Number : 8400003
Vestavia Hills, Alabama, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler- Site Number : 8400026
Chandler, Arizona, United States
Arizona Arthritis & Rheumatology Associates - South Vineyard Avenue- Site Number : 8400022
Mesa, Arizona, United States
Arizona Arthritis & Rheumatology Research - Sun City- Site Number : 8400027
Sun City, Arizona, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast- Site Number : 8400023
Tucson, Arizona, United States
Saint John's Physician Partners- Site Number : 8400015
Santa Monica, California, United States
Millennium Clinical Trials - Simi Valley- Site Number : 8400004
Simi Valley, California, United States
Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400002
DeBary, Florida, United States
Vitalia Medical Research - Margate- Site Number : 8400039
Margate, Florida, United States
Innovia Research Center- Site Number : 8400037
Miramar, Florida, United States
Integral Rheumatology and Immunology Specialists- Site Number : 8400014
Plantation, Florida, United States
Infigo Clinical Research- Site Number : 8400016
Sanford, Florida, United States
Inspire Santa Fe Medical Group- Site Number : 8400019
Santa Fe, New Mexico, United States
Columbia University Irving Medical Center- Site Number : 8400009
New York, New York, United States
RAO - Rheumatology Associates of Oklahoma- Site Number : 8400013
Oklahoma City, Oklahoma, United States
Private Practice - Dr. Ramesh C. Gupta I- Site Number : 8400008
Memphis, Tennessee, United States
Tekton Research - West Gate- Site Number : 8400001
Austin, Texas, United States
Precision Comprehensive Clinical Research Solutions - Colleyville- Site Number : 8400017
Colleyville, Texas, United States
Lone Start Arthritis & Rheumatology Associates- Site Number : 8400025
Fort Worth, Texas, United States
Prolato Clinical Research Center- Site Number : 8400005
Houston, Texas, United States
AARA Clinical Research - Lone Star Arthritis & Rheumatology Associates - Irving- Site Number : 8400024
Irving, Texas, United States
West Texas Clinical Research- Site Number : 8400018
Lubbock, Texas, United States
Investigational Site Number : 0320008
Berazategui, Buenos Aires, Argentina
Investigational Site Number : 0320003
San Miguel de Tucumán, Tucumán Province, Argentina
Investigational Site Number : 0320006
Buenos Aires, , Argentina
Investigational Site Number : 0320001
Buenos Aires, , Argentina
Investigational Site Number : 0320004
Buenos Aires, , Argentina
Investigational Site Number : 0320002
Buenos Aires, , Argentina
Centro de Estudos em Terapias Inovadoras- Site Number : 0760002
Curitiba, Paraná, Brazil
LMK Servicos Medicos- Site Number : 0760001
Porto Alegre, Rio Grande do Sul, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760006
São José do Rio Preto, São Paulo, Brazil
IBCC - Núcleo de Pesquisa e Ensino- Site Number : 0760007
São Paulo, , Brazil
Centro Paulista de Investigaçăo Clínica - CEPIC- Site Number : 0760004
São Paulo, , Brazil
Investigational Site Number : 1520002
Osorno, Los Lagos Region, Chile
Investigational Site Number : 1520003
Talca, Maule Region, Chile
Investigational Site Number : 1520004
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 2680005
Tbilisi, , Georgia
Investigational Site Number : 2680004
Tbilisi, , Georgia
Investigational Site Number : 2680001
Tbilisi, , Georgia
Investigational Site Number : 2680003
Tbilisi, , Georgia
Investigational Site Number : 2680002
Tbilisi, , Georgia
Investigational Site Number : 3000004
Athens, , Greece
Investigational Site Number : 3000001
Athens, , Greece
Investigational Site Number : 3000003
Heraklion, , Greece
Investigational Site Number : 3000005
Larissa, , Greece
Investigational Site Number : 3000002
Thessaloniki, , Greece
Investigational Site Number : 3480002
Gyula, , Hungary
Investigational Site Number : 3480003
Székesfehérvár, , Hungary
IRCCS Ospedale San Raffaele-Site Number : 3800001
Milan, Milano, Italy
Investigational Site Number: 3800004
Naples, Napoli, Italy
Fondazione Policlinico Universitario Agostino Gemelli-Site Number : 3800002
Rome, Roma, Italy
Investigational Site Number : 4800001
Vacoas, , Mauritius
Investigational Site Number : 4840009
Mexico City, Mexico City, Mexico
Investigational Site Number : 4840004
Mexico City, Mexico City, Mexico
Investigational Site Number : 4840001
Monterrey, Nuevo León, Mexico
Investigational Site Number : 4840005
Mérida, Yucatán, Mexico
Investigational Site Number : 4840006
Chihuahua City, , Mexico
Investigational Site Number : 4840011
Chihuahua City, , Mexico
Investigational Site Number : 4840007
Mexico City, , Mexico
Investigational Site Number : 4840008
Veracruz, , Mexico
GCM Medical Group - San Juan - Calle Jose Marti- Site Number : 8400011
San Juan, , Puerto Rico
Investigational Site Number : 6430002
Moscow, , Russia
Investigational Site Number : 7240002
Sabadell, Barcelona [Barcelona], Spain
Investigational Site Number : 7240001
Madrid, , Spain
Investigational Site Number : 7240005
Valencia, , Spain
Investigational Site Number : 7240004
Valladolid, , Spain
Investigational Site Number : 7560001
Sankt Gallen, , Switzerland
Investigational Site Number : 7920003
Ankara, , Turkey (Türkiye)
Investigational Site Number : 7920002
Denizli, , Turkey (Türkiye)
Investigational Site Number : 7920004
Sakarya, , Turkey (Türkiye)
Investigational Site Number : 8040006
Kyiv, , Ukraine
Investigational Site Number : 8040001
Kyiv, , Ukraine
Investigational Site Number : 8040005
Poltava, , Ukraine
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free number for US & Canada)
Role: CONTACT
Facility Contacts
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References
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Lin J, Radhakrishnan J. What Are Baskets, Umbrellas, and Platforms Doing in Nephrology Clinical Trials? J Am Soc Nephrol. 2025 Feb 3;36(8):1652-1654. doi: 10.1681/ASN.0000000648. No abstract available.
Related Links
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ACT17010 Plain Language Results Summary
Other Identifiers
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U1111-1266-5011
Identifier Type: REGISTRY
Identifier Source: secondary_id
2023-508654-26
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-001567-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ACT17010
Identifier Type: -
Identifier Source: org_study_id
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