M281 for Autoimmune Hemolytic Anemia
(ENERGY Trial)
Trial Summary
What is the purpose of this trial?
This trial is testing a medication called nipocalimab to see if it can help people with a blood disorder called warm autoimmune hemolytic anemia. The medication works by stopping the immune system from destroying red blood cells, which can help reduce anemia symptoms.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
How does the drug M281 differ from other treatments for autoimmune hemolytic anemia?
Research Team
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Eligibility Criteria
Adults over 18 with warm autoimmune hemolytic anemia (wAIHA) who are currently or previously treated for wAIHA can join. Those with cold antibody AIHA, mixed type AIHA, or paroxysmal cold hemoglobinuria cannot participate. Pregnant or breastfeeding individuals and those with other significant health issues are also excluded.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Double-blind Treatment
Participants receive M281 or placebo every 2 or 4 weeks during the double-blind period
Open-label Extension
Participants receive M281 every 2 or 4 weeks during the open-label extension period
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- M281 (Monoclonal Antibodies)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Giacomo Salvadore
Janssen Research & Development, LLC
Chief Medical Officer since 2023
MD from the University of Rome, Tor Vergata
Ricardo Attar
Janssen Research & Development, LLC
Chief Executive Officer since 2008
PhD in Molecular Biology from the University of Buenos Aires