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

NCT05039840 | Active Not Recruiting Phase 2 DMC FDA Drug

• 4 other identifiers: ACT17010U1111-1266-50112023-508654-262021-001567-25
• Study Type: interventional
• Target: 109
• Locations: 16 countries
• Sites: 73

Brief 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

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• Percentage of participants who achieved a Systemic Lupus Erythematosus Responder Index (SRI-4) response at Week 24.

  A composite endpoint, with SRI-4 response requiring a ≥ 4-point improvement (reduction) from baseline in Hybrid Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (hSELENA-SLEDAI), no new British Isles Lupus Assessment Group (BILAG-2004) A organ domain scores, or ≥ 2 new BILAG-2004 B organ domain scores compared with baseline, no worsening from baseline in lupus disease activity, and no permanent discontinuation of study drug or use of new or increased medication for SLE other than defined per protocol.

  At Week 24

Secondary Outcomes (18)

• Percentage of participants who achieved an SRI-4 response in prespecified biomarker (BM) subgroups at Week 24

  At Week 24

• Percentage of participants who achieved a BILAG-based Composite Lupus Assessment (BICLA) response in prespecified BM subgroups at Week 24

  At Week 24

• Percentage of participants who achieved a BICLA response at Week 24

  At Week 24

• Percentage of participants whose prednisone dose was ≤ 7.5 mg at Week 16 and maintained through Week 24 in the subgroup with baseline prednisone ≥10 mg/day

  Until Week 24

• Total cumulative corticosteroid dose over 24 weeks

  Until Week 24

Study Arms (2)

Frexalimab

EXPERIMENTAL

Frexalimab intravenous (IV) loading dose followed by subcutaneous (SC) doses, 24 weeks

Drug: SAR441344 IV; Drug: SAR441344 SC

Placebo

PLACEBO COMPARATOR

Placebo IV loading dose followed by SC, 24 weeks

Drug: Placebo IV; Drug: Placebo SC

Interventions

SAR441344 IV DRUG

Pharmaceutical form: solution Route of administration: Intravenous infusion

Frexalimab

SAR441344 SC DRUG

Pharmaceutical form: solution Route of administration: subcutaneous injection

Frexalimab

Placebo IV DRUG

Pharmaceutical form: solution Route of administration: Intravenous infusion

Placebo

Placebo SC DRUG

Pharmaceutical form: solution Route of administration: subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (73)

Accel Research Sites Network - Birmingham- Site Number : 8400003

Vestavia Hills, Alabama, 35216, United States

Location

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

Chandler, Arizona, 85225, United States

Location

Arizona Arthritis & Rheumatology Associates - South Vineyard Avenue- Site Number : 8400022

Mesa, Arizona, 85210, United States

Location

Arizona Arthritis & Rheumatology Research - Sun City- Site Number : 8400027

Sun City, Arizona, 85351, United States

Location

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast- Site Number : 8400023

Tucson, Arizona, 85748, United States

Location

Saint John's Physician Partners- Site Number : 8400015

Santa Monica, California, 90404, United States

Location

Millennium Clinical Trials - Simi Valley- Site Number : 8400004

Simi Valley, California, 93065, United States

Location

Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400002

DeBary, Florida, 32713, United States

Location

Vitalia Medical Research - Margate- Site Number : 8400039

Margate, Florida, 33063, United States

Location

Innovia Research Center- Site Number : 8400037

Miramar, Florida, 33027, United States

Location

Integral Rheumatology and Immunology Specialists- Site Number : 8400014

Plantation, Florida, 33324, United States

Location

Infigo Clinical Research- Site Number : 8400016

Sanford, Florida, 32771, United States

Location

Inspire Santa Fe Medical Group- Site Number : 8400019

Santa Fe, New Mexico, 87505, United States

Location

Columbia University Irving Medical Center- Site Number : 8400009

New York, New York, 10032, United States

Location

RAO - Rheumatology Associates of Oklahoma- Site Number : 8400013

Oklahoma City, Oklahoma, 73116, United States

Location

Private Practice - Dr. Ramesh C. Gupta I- Site Number : 8400008

Memphis, Tennessee, 38119, United States

Location

Tekton Research - West Gate- Site Number : 8400001

Austin, Texas, 78745, United States

Location

Precision Comprehensive Clinical Research Solutions - Colleyville- Site Number : 8400017

Colleyville, Texas, 76034, United States

Location

Lone Start Arthritis & Rheumatology Associates- Site Number : 8400025

Fort Worth, Texas, 76109, United States

Location

Prolato Clinical Research Center- Site Number : 8400005

Houston, Texas, 77054, United States

Location

AARA Clinical Research - Lone Star Arthritis & Rheumatology Associates - Irving- Site Number : 8400024

Irving, Texas, 75039, United States

Location

West Texas Clinical Research- Site Number : 8400018

Lubbock, Texas, 79410, United States

Location

Investigational Site Number : 0320008

Berazategui, Buenos Aires, 1886, Argentina

Location

Investigational Site Number : 0320003

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Investigational Site Number : 0320006

Buenos Aires, 1023, Argentina

Location

Investigational Site Number : 0320001

Buenos Aires, 1111, Argentina

Location

Investigational Site Number : 0320004

Buenos Aires, 1121, Argentina

Location

Investigational Site Number : 0320002

Buenos Aires, 1430, Argentina

Location

Centro de Estudos em Terapias Inovadoras- Site Number : 0760002

Curitiba, Paraná, 80030-110, Brazil

Location

LMK Servicos Medicos- Site Number : 0760001

Porto Alegre, Rio Grande do Sul, 90480-000, Brazil

Location

Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760006

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

IBCC - Núcleo de Pesquisa e Ensino- Site Number : 0760007

São Paulo, 04014-002, Brazil

Location

Centro Paulista de Investigaçăo Clínica - CEPIC- Site Number : 0760004

São Paulo, 04265-000, Brazil

Location

Investigational Site Number : 1520002

Osorno, Los Lagos Region, 5311092, Chile

Location

Investigational Site Number : 1520003

Talca, Maule Region, 3465584, Chile

Location

Investigational Site Number : 1520004

Santiago, Reg Metropolitana de Santiago, 7510047, Chile

Location

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, 7640881, Chile

Location

Investigational Site Number : 2680005

Tbilisi, 0102, Georgia

Location

Investigational Site Number : 2680004

Tbilisi, 0114, Georgia

Location

Investigational Site Number : 2680001

Tbilisi, 0131, Georgia

Location

Investigational Site Number : 2680003

Tbilisi, 0159, Georgia

Location

Investigational Site Number : 2680002

Tbilisi, 0186, Georgia

Location

Investigational Site Number : 3000004

Athens, 115 27, Greece

Location

Investigational Site Number : 3000001

Athens, 124 62, Greece

Location

Investigational Site Number : 3000003

Heraklion, 711 10, Greece

Location

Investigational Site Number : 3000005

Larissa, 415 00, Greece

Location

Investigational Site Number : 3000002

Thessaloniki, 546 36, Greece

Location

Investigational Site Number : 3480002

Gyula, 5700, Hungary

Location

Investigational Site Number : 3480003

Székesfehérvár, 8000, Hungary

Location

IRCCS Ospedale San Raffaele-Site Number : 3800001

Milan, Milano, 20132, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli-Site Number : 3800002

Rome, Roma, 00168, Italy

Location

Investigational Site Number : 4800001

Vacoas, 72218, Mauritius

Location

Investigational Site Number : 4840009

Mexico City, Mexico City, 03100, Mexico

Location

Investigational Site Number : 4840004

Mexico City, Mexico City, 06700, Mexico

Location

Investigational Site Number : 4840001

Monterrey, Nuevo León, 64460, Mexico

Location

Investigational Site Number : 4840005

Mérida, Yucatán, 97070, Mexico

Location

Investigational Site Number : 4840006

Chihuahua City, 31000, Mexico

Location

Investigational Site Number : 4840011

Chihuahua City, 31210, Mexico

Location

Investigational Site Number : 4840007

Mexico City, 11850, Mexico

Location

Investigational Site Number : 4840008

Veracruz, 91900, Mexico

Location

GCM Medical Group - San Juan - Calle Jose Marti- Site Number : 8400011

San Juan, 00917, Puerto Rico

Location

Investigational Site Number : 6430002

Moscow, 111539, Russia

Location

Investigational Site Number : 7240002

Sabadell, Barcelona [Barcelona], 08208, Spain

Location

Investigational Site Number : 7240001

Madrid, 28046, Spain

Location

Investigational Site Number : 7240005

Valencia, 46014, Spain

Location

Investigational Site Number : 7240004

Valladolid, 47012, Spain

Location

Investigational Site Number : 7560001

Sankt Gallen, 9007, Switzerland

Location

Investigational Site Number : 7920003

Ankara, 06800, Turkey (Türkiye)

Location

Investigational Site Number : 7920002

Denizli, 20070, Turkey (Türkiye)

Location

Investigational Site Number : 7920004

Sakarya, 54100, Turkey (Türkiye)

Location

Investigational Site Number : 8040006

Kyiv, 02091, Ukraine

Location

Investigational Site Number : 8040001

Kyiv, 02125, Ukraine

Location

Investigational Site Number : 8040005

Poltava, 36011, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 39899371 DERIVED

Related Links

• ACT17010 Plain Language Results Summary

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 10, 2021
• Study Start: November 10, 2021
• Primary Completion (Estimated): July 10, 2026
• Study Completion (Estimated): October 2, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

AR (6); TU (3); RU (1); GE (5); BR (5); CH (1); PR (1); UA (3); CL (4); ES (4); MA (1); US (22); ME (8); HU (2); GR (5); IT (2)