ENERGY Study

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The ENERGY study is for adults (ages 18 and up) with warm Autoimmune Hemolytic Anemia (wAIHA) who are currently receiving treatment or have previously received treatment. The goal of the study is to see if the study drug, Nipocalimab is safe and effective in the treatment of wAIHA. Nipocalimab is an investigational medication designed to stop your immune system from destroying your red blood cells.
You may be able to join the study if you are:

  • 18 years of age or older.
  • Diagnosed with wAIHA for at least 3 months.
  • Currently receiving treatment or have previously received treatment for wAIHA
  • Have platelet counts of more than 30,000/ L and Hemoglobin less than 10 g/dL

 Otherr study requirements will apply.

Who Do I Contact?

If you are interested in participating in the study or want to learn more please contact our study team at arulselvaa [at] chop.edu or 215-590-3582.

Eligibility & Criteria

IRB #:
19-016799
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
Study Phase:
Phase I
Phase II
Eligible Age Range:
18 - 100 Years
Gender:
All
Study Categories:

Visit Criteria

If you qualify and decide to participate, your study participation will last for about 14.5 months. You will be randomly assigned to receive either the study drug or placebo (which has no active ingredients) as an infusion every 2 weeks. About 1 out of 3 patients will receive placebo in the first part of the study, but everyone will have the option to receive the study medication later in the study.

You will be required to report to CHOP about every 2 weeks for receiving the study drug, blood tests and physical exams. You may benefit if the study drug lessens the symptoms associated with your anemia.