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Isatuximab SAR650984
Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic Anemia (wAIHA)
Ensayo de Sanofi en Warm Autoimmune Hemolytic Anemia (wAIHA) (del registro, en inglés).
- Fase
- Fase 2
- Estado
- Interrumpido
- Participantes
- 8
- Centros
- 6
- Fin del objetivo primario
- jun 2023
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en sep 2021.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Study discontinuation based on strategic sponsor decision; not driven by any safety concerns.».
Qué mide
Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) And Treatment Emergent Serious Adverse Events (TESAEs) (From first dose of study drug (Day 1) up to 30 days after last study intervention administration, approximately 101 days) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary Objectives: * Part A: To evaluate the safety and tolerability of subcutaneous injections of isatuximab in adults with wAIHA * Part B: To evaluate the efficacy of the selected dose in adults with wAIHA Secondary Objectives: * Part A (Cohorts 2 and 3 only) * To evaluate the efficacy of isatuximab in adults with wAIHA * To evaluate the durability of response to isatuximab and time to response * To evaluate the impact of isatuximab treatment on fatigue Part B * To evaluate the safety and tolerability of isatuximab in adults with wAIHA * To evaluate the durability of response to isatuximab and time to response * To evaluate the impact of isatuximab treatment on fatigue Parts A (all Cohorts) and B * To evaluate the effect of isatuximab on markers of hemolysis * To characterize the pharmacokinetic profile of isatuximab in adults with wAIHA * To evaluate the immunogenicity of isatuximab
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| Isatuximab IV · IRAKLIA | Fase 3 | En marcha, sin reclutar | nov 2024 (real) |
Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT04661033), actualizada en dic 2024.