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New lupus drug candidate enters Mid-Stage trial

NCT ID NCT05039840

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

109 people

The number who actually took part.

Started

Nov 2021

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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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

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

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