LUNA 3

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The LUNA 3 study is for teenagers and adults (ages 12 and up) with primary immune thrombocytopenia (ITP) for which standard medications are no longer working. The goal of the study is to see if the study drug, Rilzabrutinib can safely increase platelet counts and improve symptoms for people with ITP. Rilzabrutinib is an investigational medication designed to stop your immune system from destroying your platelets. You may be able to join the study if you are:

  • 12 years of age or older.
  • Diagnosed with primary ITP for at least 6 months for ages 12 through 17 or for at least 3 months for ages 18 and up.
  • Have taken IVIg or steroids, but they are no longer working.
  • Have platelet counts of less than 30,000.

Other 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 kondep [at] chop.edu or 267-426-7634.

Eligibility & Criteria

IRB #:
20-018099
Official Title:
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- Controlled, Parallel-Group Study With An Open-Label Extension To Evaluate The Efficacy And Safety Of Oral Rilzabrutinib (PRN1008) In Adults And Adolescents With Persistent Or Chronic Immune Thrombocytopenia (ITP)
Study Phase:
Phase III
Eligible Age Range:
12 - 99 Years
Gender:
All
Study Categories:
Downloadable Resources:

FLYER
LUNA BROCHURE
PARTICIPANT JOURNEY

Visit Criteria

If you qualify and decide to participate, your study participation will last for about 1 year. You will randomly be assigned to receive either the study drug or placebo (which has no active ingredients). You will swallow 1 pill twice daily. 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 for visits about every 4 weeks for about 1 year for blood tests and physical exams. In addition, there will be weekly blood draws. This may be done at CHOP or at home by a healthcare professional (if this service is available where you live).

If the study medication improves your platelet counts, you may qualify to participate in an extension of the study, in which you will receive the study drug for an additional year. During that year, you will visit CHOP monthly.

Leader
Michele Lambert

Michele Lambert, MD, MSTR