NCT04661033

Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic Anemia (wAIHA)

A Multicenter, Open-label, Non-randomized, Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic Anemia

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary 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

Detailed description

28 weeks (including screening)

Conditions

• Warm Autoimmune Hemolytic Anemia (wAIHA)

Interventions

Type	Name	Description
DRUG	Isatuximab SAR650984	Pharmaceutical form:Solution for injection Route of administration: Subcutaneous

Timeline

• Start date: 2021-09-09
• Primary completion: 2023-06-26
• Completion: 2023-06-26
• First posted: 2020-12-09
• Last updated: 2024-12-05
• Results posted: 2024-08-27

Locations

6 sites across 6 countries: United States, France, Germany, Italy, Netherlands, United Kingdom

Regulatory

• FDA-regulated drug study