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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05039840
Other study ID # ACT17010
Secondary ID U1111-1266-50112
Status Recruiting
Phase Phase 2
First received
Last updated
Start date November 10, 2021
Est. completion date September 1, 2025

Study information

Verified date March 2024
Source Sanofi
Contact Trial Transparency email recommended (Toll free number for US &
Phone 800-633-1610
Email Contact-US@sanofi.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 116
Est. completion date September 1, 2025
Est. primary completion date June 9, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Intervention

Drug:
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

Locations

Country Name City State
Argentina Investigational Site Number : 0320008 Berazategui Buenos Aires
Argentina Investigational Site Number : 0320004 Buenos Aires
Argentina Investigational Site Number : 0320001 Caba Buenos Aires
Argentina Investigational Site Number : 0320002 Caba Buenos Aires
Argentina Investigational Site Number : 0320006 Caba Buenos Aires
Argentina Investigational Site Number : 0320003 San Miguel de Tucuman
Brazil CETI - Centro de Estudos em Terapias Inovadoras Site Number : 0760002 Curitiba Paraná
Brazil LMK Servicos Medicos Ss Site Number : 0760001 Porto Alegre Rio Grande Do Sul
Brazil Centro Integrado de Pesquisa Site Number : 0760006 Sao Jose do Rio Preto São Paulo
Brazil CEPIC - Centro Paulista De Investigacao Clinica Site Number : 0760004 Sao Paulo São Paulo
Brazil Nucleo de Pesquisa Clinica e Ensino da Rede Sao Camilo Site Number : 0760007 Sao Paulo São Paulo
Chile Investigational Site Number : 1520002 Osorno Los Lagos
Chile Investigational Site Number : 1520001 Santiago Reg Metropolitana De Santiago
Chile Investigational Site Number : 1520004 Santiago Reg Metropolitana De Santiago
Chile Investigational Site Number : 1520003 Talca Maule
Greece Investigational Site Number : 3000001 Athens
Greece Investigational Site Number : 3000004 Athens
Greece Investigational Site Number : 3000003 Heraklion
Greece Investigational Site Number : 3000005 Larissa
Greece Investigational Site Number : 3000002 Thassaloniki
Hungary Investigational Site Number : 3480002 Gyula
Hungary Investigational Site Number : 3480003 Székesfehérvár
Italy Investigational Site Number : 3800003 Firenze
Italy Investigational Site Number : 3800001 Milano
Italy Investigational Site Number : 3800004 Napoli
Italy Investigational Site Number : 3800002 Roma Lazio
Mauritius Investigational Site Number : 4800001 Quatre Bornes
Mexico Investigational Site Number : 4840009 \\Ciudad de México Ciudad De Mexico
Mexico Investigational Site Number : 4840002 Benito Juarez
Mexico Investigational Site Number : 4840006 Chihuahua
Mexico Investigational Site Number : 4840011 Chihuahua
Mexico Investigational Site Number : 4840004 Mexico
Mexico Investigational Site Number : 4840007 México, D.F. México
Mexico Investigational Site Number : 4840001 Monterrey Nuevo León
Mexico Investigational Site Number : 4840008 Veracruz
Mexico Investigational Site Number : 4840005 Yucatan
Puerto Rico GCM Medical Group Site Number : 8400011 San Juan
Russian Federation Investigational Site Number : 6430002 Moscow
Spain Investigational Site Number : 7240002 Barcelona / Sabadell Castilla Y León
Spain Investigational Site Number : 7240001 Madrid Madrid, Comunidad De
Turkey Investigational Site Number : 7920001 Ankara
Turkey Investigational Site Number : 7920003 Ankara
Turkey Investigational Site Number : 7920002 Denizli
Ukraine Investigational Site Number : 8040001 Kyiv
Ukraine Investigational Site Number : 8040006 Kyiv
Ukraine Investigational Site Number : 8040005 Poltava
United States Tekton Research, Inc Site Number : 8400001 Austin Texas
United States Achieve Clinical Research Site Number : 8400003 Birmingham Alabama
United States Omega Research Site Number : 8400002 DeBary Florida
United States Prolato Clinical Research Center Site Number : 8400005 Houston Texas
United States Ramesh C. Gupta, M.D. Site Number : 8400008 Memphis Tennessee
United States Columbia University Medical Center Site Number : 8400009 New York New York
United States RAO Research, LLC Site Number : 8400013 Oklahoma City Oklahoma
United States Millennium Clinical Trials Site Number : 8400004 Thousand Oaks California

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Chile,  Greece,  Hungary,  Italy,  Mauritius,  Mexico,  Puerto Rico,  Russian Federation,  Spain,  Turkey,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Percentage of participants who achieved an SRI-4 response in prespecified biomarker (BM) subgroups at Week 24 At Week 24
Secondary Percentage of participants who achieved a BILAG-based Composite Lupus Assessment (BICLA) response in prespecified BM subgroups at Week 24 At Week 24
Secondary Percentage of participants who achieved a BICLA response at Week 24 At Week 24
Secondary 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
Secondary Total cumulative corticosteroid dose over 24 weeks Until Week 24
Secondary Percentage of participants achieving an SRI-4 response at week 24 with sustained reduction of oral corticosteroids At Week 24
Secondary Percent change from baseline in percentage in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-A at Week 24 in the subgroup of participants with baseline CLASI-A score =8 At Week 24
Secondary Percentage of participants with =50% improvement in CLASI-A at Week 24 in the subgroup of participants with baseline CLASI-A score =8 At Week 24
Secondary Percentage of participants with =50% improvement in the number of tender and swollen joints at Week 24 (among participants with at least 4 joints affected at baseline) At Week 24
Secondary Incidence of treatment-emergent AEs (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs) from Baseline to Week 36 End of Study (EoS) Until Week 36
Secondary Incidence of study investigational medicinal product permanent discontinuations and study withdrawals due to TEAEs from Baseline to Week 36 (EoS) Until Week 36
Secondary Participants with medically significant changes in vital signs, electrocardiogram (ECG), and/or laboratory evaluation Until Week 36
Secondary Measurement of anti-drug antibodies (ADA) (before administration at Week 0, 4, 8, 12, 16, 20, 24 and after treatment discontinuation at Week 36) Until Week 36
Secondary SAR441344 concentrations over time Until Week 36
Secondary Pharmacokinetic parameters: maximum concentration (Cmax) Until Week 36
Secondary Pharmacokinetic parameters: time to Cmax (tmax) Until Week 36
Secondary Pharmacokinetic parameters: area under the curve over the dosing interval (AUC0-tau) Until Week 36
Secondary Pharmacokinetic parameters: terminal half-life (t1/2z). Until Week 36
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