LUNA 3

LUNA 3

Contact

 If you are interested in participating in the study or want to learn more, please get in touch. Contact us
This study is now recruiting. Learn more about enrolling here.

Description
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.

Eligibility and criteria
IRB Number:
20-018099
Eligible age range:
12 years - 99 years
Clinical trial phase:
Phase III
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).

What to expect
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 inthe 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.

Related specialties
Smiling CHOP patient holding shopping bag

We need families like you

Your time and participation make a difference in supporting the work of the Research Institute and children in our community. Learn more about opportunities to participate in our research.