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SAR113244
Pharmacodynamics Assessment Study After Single Subcutaneous Dose Of SAR113244 Versus Placebo In Lupus Male And Female Patients
Ensayo de Sanofi en Lupus eritematoso sistemico.
Más ensayos de: Lupus eritematoso sistémico.
- Fase
- Fase 1
- Estado
- Retirado antes de empezar
- Fin del objetivo primario
- may 2017
estimado por el promotor
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, doble ciego. Comenzó en abr 2016.
Qué mide
Percentage decrease in B cell subsets (expressed as percentages of total B-cells) from baseline (Up to Day 57 after inclusion) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary Objective: Assess in systemic lupus erythematosus (SLE) patients the effect of SAR113244 on B-cell subsets compared to placebo. Secondary Objectives: Assess in male and female lupus patients after SC single dose of SAR113244 the tolerability and safety of SAR113244. Assess in male and female lupus patients: * The pharmacokinetics of SAR113244. * The pharmacodynamics of SAR113244 for the following disease parameters: * Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score, British Isles Lupus Assessment Group (BILAG) score (if applicable), BILAG-Based Composite Lupus Assessment (BICLA) (if applicable), systemic lupus erythematosus responder index (if applicable), Lupus-quality of life and Functional Assessment of Chronic Illness Therapy-Fatigue, anti-double stranded deoxyribonucleic acid antibody and anti-nuclear antibody levels and plasma complement levels (C3, C4), erythrocyte sedimentation rate and C-reactive protein. * Peripheral blood B and T cell subsets.
Más ensayos de SNY
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Avalglucosidase alfa · Mini-COMET | Fase 2 | En marcha, sin reclutar | sep 2019 (real) |
| Yellow fever vaccine | Fase 2 | En marcha, sin reclutar | may 2022 (real) |
| Yellow fever vaccine · VYF02 | Fase 2 | En marcha, sin reclutar | jun 2022 (real) |
| SAR441344 IV | Fase 2 | En marcha, sin reclutar | sep 2022 (real) |
| Meningococcal Polysaccharide | Fase 3 | En marcha, sin reclutar | mar 2023 (real) |
| Isatuximab IV · IRAKLIA | Fase 3 | En marcha, sin reclutar | nov 2024 (real) |
Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT02331810), actualizada en jun 2016.