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ACTIVE NOT RECRUITING

NCT05039840

PHASE2

Efficacy and Safety of Frexalimab (SAR441344) in the Treatment of Systemic Lupus Erythematosus

Sponsor: Sanofi

View on ClinicalTrials.gov

Summary

This is a multinational, randomized, placebo-controlled, parallel treatment, Phase 2, double-blind, 2 arm study evaluating the efficacy and safety of SAR441344 in comparison with placebo in the treatment of participants aged 18 to 70 years with active Systemic Lupus Erythematosus (SLE). Study details include: * Study duration: 36 weeks * Treatment duration: 24 weeks * Visit frequency: every 2 weeks

Official title: Efficacy and Safety of SAR441344 in the Treatment of Systemic Lupus Erythematosus: A Randomized, Double Blind, Placebo-controlled, Phase 2, Proof of Concept Study

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

109

Start Date

2021-11-10

Completion Date

2026-10-02

Last Updated

2026-03-27

Healthy Volunteers

Conditions

Systemic Lupus Erythematosus

Interventions

DRUG

SAR441344 IV

Pharmaceutical form: solution Route of administration: Intravenous infusion

DRUG

SAR441344 SC

Pharmaceutical form: solution Route of administration: subcutaneous injection

DRUG

Placebo IV

Pharmaceutical form: solution Route of administration: Intravenous infusion

DRUG

Placebo SC

Pharmaceutical form: solution Route of administration: subcutaneous injection

Inclusion Criteria: * Diagnosis of SLE for at least 6 months prior to screening by fulfilling the Revised Criteria for Classification of SLE according to the 1997 Update of the 1982 ACR 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: * Primary diagnosis of a rheumatic disease besides SLE or an inflammatory joint or skin 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 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.

Locations (73)

Accel Research Sites Network - Birmingham- 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

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

Clinical Research Directory

Efficacy and Safety of Frexalimab (SAR441344) in the Treatment of Systemic Lupus Erythematosus

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (73)