Efficacy and Safety of SAR441344 in the Treatment of Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

— APATURA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05039840
• Other study ID #: ACT17010
• Secondary ID: U1111-1266-50112
• Status: Recruiting
• Phase: Phase 2
• Start date: November 10, 2021
• Est. completion date: November 30, 2026

Study information

• Verified date: June 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
• 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: November 30, 2026
• Est. primary completion date: September 7, 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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

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 : 0320001	Caba	Buenos Aires
Argentina	Investigational Site Number : 0320002	Caba	Buenos Aires
Argentina	Investigational Site Number : 0320006	Caba	Buenos Aires
Argentina	Investigational Site Number : 0320004	Ciudad Autonoma Bs As
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
Switzerland	Investigational Site Number : 7560001	St. Gallen
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	Precision Comprehensive Clinical Research Solutions/Heritage Rheumatology Site Number : 8400017	Colleyville	Texas
United States	Omega Research Site Number : 8400002	DeBary	Florida
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	Lone Star Arthritis & Rheumatology Associates Site Number : 8400024	Irving	Texas
United States	West Texas Clinical Research Site Number : 8400018	Lubbock	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	Infigo Clinical Research Site Number : 8400016	Sanford	Florida
United States	Millennium Clinical Trials Site Number : 8400004	Simi Valley	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,  Switzerland,  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