Resumen

Se trata de un estudio multinacional, aleatorizado, controlado con placebo, de tratamiento paralelo, de fase 2, doble ciego, de 2 brazos, que evalúa la eficacia y seguridad de SAR441344 en comparación con placebo en el tratamiento de participantes de entre 18 y 70 años con lupus eritematoso sistémico (LES) activo. Los detalles del estudio incluyen: * Duración del estudio: 36 semanas * Duración del tratamiento: 24 semanas * Frecuencia de visitas: cada 2 semanas

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 70 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

drug

SAR441344 IV

Pharmaceutical form: solution Route of administration: Intravenous infusion

drug

SAR441344 SC

Pharmaceutical form: solution Route of administration: subcutaneous injection

drug

Placebo IV

Pharmaceutical form: solution Route of administration: Intravenous infusion

drug

Placebo SC

Pharmaceutical form: solution Route of administration: subcutaneous injection

Ubicaciones

Investigational Site Number : 0320008

Berazategui, Buenos Aires, Argentina

COMPLETED

Investigational Site Number : 0320003

San Miguel de Tucumán, Tucumán Province, Argentina

COMPLETED

Investigational Site Number : 0320006

Buenos Aires, Argentina

COMPLETED

Investigational Site Number : 0320001

Buenos Aires, Argentina

COMPLETED

Investigational Site Number : 0320004

Buenos Aires, Argentina

COMPLETED

Investigational Site Number : 0320002

Buenos Aires, Argentina

COMPLETED

Eficacia y seguridad de SAR441344 en el tratamiento del lupus eritematoso sistémico: estudio de fase 2, aleatorizado, doble ciego, controlado con placebo, de prueba de concepto

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

SAR441344 IV

SAR441344 SC

Placebo IV

Placebo SC

Ubicaciones

Investigational Site Number : 0320008

Investigational Site Number : 0320003

Investigational Site Number : 0320006

Investigational Site Number : 0320001

Investigational Site Number : 0320004

Investigational Site Number : 0320002

Patrocinadores

Contactos

Trial Transparency email recommended (Toll free number for US & Canada)