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

Warm Autoimmune Hemolytic Anemia (wAIHA) Clinical Trial

Official title:
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

Clinical Trial 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

Clinical Trial Description

28 weeks (including screening) ;

Study Design

Related Conditions & MeSH terms

Anemia
Anemia, Hemolytic
Anemia, Hemolytic, Autoimmune
Hemolysis
Warm Autoimmune Hemolytic Anemia (wAIHA)

Clinical Trial Details

NCT number	NCT04661033
Study type	Interventional
Source	Sanofi
Contact
Status	Terminated
Phase	Phase 1/Phase 2
Start date	September 9, 2021
Completion date	June 26, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04691570` - Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ANX005 in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA)	Phase 2
Terminated	`NCT05073458` - Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia	Phase 3
Completed	`NCT02502903` - Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement Mediated Disorders	Phase 1
Active, not recruiting	`NCT05002777` - Efficacy, Safety and Pharmacokinetics of Rilzabrutinib in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA)	Phase 2
Recruiting	`NCT05648968` - A Study of Efficacy and Safety of Ianalumab in Previously Treated Patients With Warm Autoimmune Hemolytic Anemia	Phase 3