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Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia — ENERGY  

Warm Autoimmune Hemolytic Anemia Clinical Trial

Official title:
Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Study With a Long-term Open-label Extension

Clinical Trial Summary

The main purpose of this study is to evaluate the efficacy and safety of M281 in participants with warm autoimmune hemolytic anemia (wAIHA).

Clinical Trial Description

The study consists of a 24-week double-blind, placebo control period, a 144-week open-label extension period and follow-up period of 8 weeks after last study drug administration. Eligible participants will be randomized to placebo or nipocalimab (2 dose levels) during the double-blind period and nipocalimab (2 dose levels) during the open-label extension period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04119050
Study type Interventional
Source Janssen Research & Development, LLC
Contact Study Contact
Phone 844-434-4210
Email Participate-In-This-Study@its.jnj.com
Status Recruiting
Phase Phase 2/Phase 3
Start date August 15, 2019
Completion date April 10, 2028
View Details
See also
  Status Clinical Trial Phase
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Recruiting NCT05922839 - Zanubrutinib in the Treatment of Relapsed/Refractory wAIHA Phase 2
Completed NCT01181154 - Rituximab in Auto-Immune Hemolytic Anemia Phase 3
Recruiting NCT05925023 - Sirolimus in the Treatment of Refractory/Relapsed wAIHA Phase 2
Recruiting NCT05757570 - An Open-label Study of Povetacicept in Subjects With Autoimmune Cytopenias Phase 1/Phase 2
Withdrawn NCT04256148 - ALXN1830 in Patients With Warm Autoimmune Hemolytic Anemia Phase 2
Terminated NCT03075878 - A Safety Study of SYNT001 in Participants With Warm Autoimmune Hemolytic Anemia (WAIHA) Phase 1/Phase 2
Withdrawn NCT04956276 - Subcutaneous ALXN1830 in Adult Participants With Warm Autoimmune Hemolytic Anemia Phase 2
Completed NCT03226678 - Study to Assess the Safety, Tolerability, Efficacy and PK of APL-2 in Patients With Warm Type Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD) Phase 2
Terminated NCT04253236 - To Assess the Efficacy and Safety of RVT-1401 in the Treatment of Warm Autoimmune Hemolytic Anemia (ASCEND-WAIHA). Phase 2
Temporarily not available NCT05221619 - Post-trial Access for Nipocalimab in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA)