New lupus drug candidate enters Mid-Stage trial

NCT ID NCT05039840

Ongoing Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 trial tests whether the experimental drug SAR441344 can safely control disease activity in people with active systemic lupus erythematosus (SLE). About 109 adults aged 18–70 will receive either the drug or a placebo for 24 weeks. The main goal is to see if more people on the drug achieve a meaningful reduction in lupus symptoms compared to placebo.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

SAR441344 (an experimental drug given by IV or injection)

What this could lead to

If successful, this could point toward a new treatment option to control lupus disease activity and reduce flares.

What could go wrong

This is an early Phase 2 proof-of-concept study with only 109 participants. The drug may not work better than placebo, and side effects are still being evaluated.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SYSTEMIC LUPUS ERYTHEMATOSUS

Contacts and locations

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Locations

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler- Site Number : 8400026

Chandler, Arizona, 85225, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast- Site Number : 8400023

Tucson, Arizona, 85748, United States
AARA Clinical Research - Lone Star Arthritis & Rheumatology Associates - Irving- Site Number : 8400024

Irving, Texas, 75039, United States
Accel Research Sites Network - Birmingham- Site Number : 8400003

Vestavia Hills, Alabama, 35216, United States
Arizona Arthritis & Rheumatology Associates - South Vineyard Avenue- Site Number : 8400022

Mesa, Arizona, 85210, United States
Arizona Arthritis & Rheumatology Research - Sun City- Site Number : 8400027

Sun City, Arizona, 85351, United States
Centro Paulista de Investigaçăo Clínica - CEPIC- Site Number : 0760004

São Paulo, 04265-000, Brazil
Centro de Estudos em Terapias Inovadoras- Site Number : 0760002

Curitiba, Paraná, 80030-110, Brazil
Columbia University Irving Medical Center- Site Number : 8400009

New York, New York, 10032, United States
Fondazione Policlinico Universitario Agostino Gemelli-Site Number : 3800002

Rome, Roma, 00168, Italy
Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760006

São José do Rio Preto, São Paulo, 15090-000, Brazil
GCM Medical Group - San Juan - Calle Jose Marti- Site Number : 8400011

San Juan, 00917, Puerto Rico
IBCC - Núcleo de Pesquisa e Ensino- Site Number : 0760007

São Paulo, 04014-002, Brazil
IRCCS Ospedale San Raffaele-Site Number : 3800001

Milan, Milano, 20132, Italy
Infigo Clinical Research- Site Number : 8400016

Sanford, Florida, 32771, United States
Innovia Research Center- Site Number : 8400037

Miramar, Florida, 33027, United States
Inspire Santa Fe Medical Group- Site Number : 8400019

Santa Fe, New Mexico, 87505, United States
Integral Rheumatology and Immunology Specialists- Site Number : 8400014

Plantation, Florida, 33324, United States
Investigational Site Number : 0320001

Buenos Aires, 1111, Argentina
Investigational Site Number : 0320002

Buenos Aires, 1430, Argentina
Investigational Site Number : 0320003

San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Investigational Site Number : 0320004

Buenos Aires, 1121, Argentina
Investigational Site Number : 0320006

Buenos Aires, 1023, Argentina
Investigational Site Number : 0320008

Berazategui, Buenos Aires, 1886, Argentina
Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, 7640881, Chile
Investigational Site Number : 1520002

Osorno, Los Lagos Region, 5311092, Chile
Investigational Site Number : 1520003

Talca, Maule Region, 3465584, Chile
Investigational Site Number : 1520004

Santiago, Reg Metropolitana de Santiago, 7510047, Chile
Investigational Site Number : 2680001

Tbilisi, 0131, Georgia
Investigational Site Number : 2680002

Tbilisi, 0186, Georgia
Investigational Site Number : 2680003

Tbilisi, 0159, Georgia
Investigational Site Number : 2680004

Tbilisi, 0114, Georgia
Investigational Site Number : 2680005

Tbilisi, 0102, Georgia
Investigational Site Number : 3000001

Athens, 124 62, Greece
Investigational Site Number : 3000002

Thessaloniki, 546 36, Greece
Investigational Site Number : 3000003

Heraklion, 711 10, Greece
Investigational Site Number : 3000004

Athens, 115 27, Greece
Investigational Site Number : 3000005

Larissa, 415 00, Greece
Investigational Site Number : 3480002

Gyula, 5700, Hungary
Investigational Site Number : 3480003

Székesfehérvár, 8000, Hungary
Investigational Site Number : 4800001

Vacoas, 72218, Mauritius
Investigational Site Number : 4840001

Monterrey, Nuevo León, 64460, Mexico
Investigational Site Number : 4840004

Mexico City, Mexico City, 06700, Mexico
Investigational Site Number : 4840005

Mérida, Yucatán, 97070, Mexico
Investigational Site Number : 4840006

Chihuahua City, 31000, Mexico
Investigational Site Number : 4840007

Mexico City, 11850, Mexico
Investigational Site Number : 4840008

Veracruz, 91900, Mexico
Investigational Site Number : 4840009

Mexico City, Mexico City, 03100, Mexico
Investigational Site Number : 4840011

Chihuahua City, 31210, Mexico
Investigational Site Number : 6430002

Moscow, 111539, Russia
Investigational Site Number : 7240001

Madrid, 28046, Spain
Investigational Site Number : 7240002

Sabadell, Barcelona [Barcelona], 08208, Spain
Investigational Site Number : 7240004

Valladolid, 47012, Spain
Investigational Site Number : 7240005

Valencia, 46014, Spain
Investigational Site Number : 7560001

Sankt Gallen, 9007, Switzerland
Investigational Site Number : 7920002

Denizli, 20070, Turkey (Türkiye)
Investigational Site Number : 7920003

Ankara, 06800, Turkey (Türkiye)
Investigational Site Number : 7920004

Sakarya, 54100, Turkey (Türkiye)
Investigational Site Number : 8040001

Kyiv, 02125, Ukraine
Investigational Site Number : 8040005

Poltava, 36011, Ukraine
Investigational Site Number : 8040006

Kyiv, 02091, Ukraine
LMK Servicos Medicos- Site Number : 0760001

Porto Alegre, Rio Grande do Sul, 90480-000, Brazil
Lone Start Arthritis & Rheumatology Associates- Site Number : 8400025

Fort Worth, Texas, 76109, United States
Millennium Clinical Trials - Simi Valley- Site Number : 8400004

Simi Valley, California, 93065, United States
Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400002

DeBary, Florida, 32713, United States
Precision Comprehensive Clinical Research Solutions - Colleyville- Site Number : 8400017

Colleyville, Texas, 76034, United States
Private Practice - Dr. Ramesh C. Gupta I- Site Number : 8400008

Memphis, Tennessee, 38119, United States
Prolato Clinical Research Center- Site Number : 8400005

Houston, Texas, 77054, United States
RAO - Rheumatology Associates of Oklahoma- Site Number : 8400013

Oklahoma City, Oklahoma, 73116, United States
Saint John's Physician Partners- Site Number : 8400015

Santa Monica, California, 90404, United States
Tekton Research - West Gate- Site Number : 8400001

Austin, Texas, 78745, United States
Vitalia Medical Research - Margate- Site Number : 8400039

Margate, Florida, 33063, United States
West Texas Clinical Research- Site Number : 8400018

Lubbock, Texas, 79410, United States