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Bruton's Tyrosine Kinase (BTK) Inhibitor

Rilzabrutinib for Immune Thrombocytopenia (LUNA 3 Trial)

Phase 3
Research Sponsored by Principia Biopharma, a Sanofi Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate hematologic, hepatic, and renal function (absolute neutrophil count ≥1.5 X 10^9/L, AST/ALT ≤1.5 x upper limit of normal [ULN], albumin ≥3 g/dL, total bilirubin ≤1.5 x ULN [unless the patient has documented Gilbert syndrome], glomerular filtration rate >50 [Cockcroft and Gault method])
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks of treatment, 12 months of long term extension and 4 weeks of follow up post last dose
Awards & highlights

LUNA 3 Trial Summary

This trial is testing a drug called rilzabrutinib to see if it can help people with a blood disorder called ITP. The trial will last up to 60 weeks and will involve taking the drug or a placebo twice daily.

Who is the study for?
Adults and adolescents with persistent or chronic immune thrombocytopenia (ITP) who have a very low platelet count are eligible for this trial. They must not be pregnant, planning surgery soon, or have had certain treatments like blood transfusions recently. Participants need to agree to use contraception and cannot have other health conditions that might interfere with the study.Check my eligibility
What is being tested?
The trial is testing Rilzabrutinib, a potential new treatment for ITP. Patients will either receive Rilzabrutinib or a placebo twice daily over several weeks to see if it helps increase their platelet counts compared to no active treatment.See study design
What are the potential side effects?
While specific side effects of Rilzabrutinib aren't listed here, similar medications can cause issues like headaches, nausea, diarrhea, muscle pain, and could potentially affect liver function tests. Side effects vary from person to person.

LUNA 3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
My blood, liver, and kidney tests are within normal ranges.

LUNA 3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks of treatment, 12 months of long term extension and 4 weeks of follow up post last dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks of treatment, 12 months of long term extension and 4 weeks of follow up post last dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Durable platelet response during the last 6 weeks of the 24-week blinded treatment period (not for EU and UK)
for EU and UK: Proportion of adult participants able to achieve platelet counts at or above 50,000/μL for at least 8 out of the last 12 weeks of the 24-week blinded treatment period in the absence of rescue therapy
Secondary outcome measures
Change from baseline in disease-specific QoL as measured by the Kids' ITP Tools (ITP-KIT) score in pediatric participants
Change from baseline on Item 10 of the ITP-Patient Assessment Questionnaire in adult patients (≥18 years) at Week 13
Change from baseline on the Symptoms, Bother and Activity domains of the ITP Patient Assessment Questionnaire (ITP-PAQ) in adult patients (≥18 years)
+9 more

LUNA 3 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RilzabrutinibExperimental Treatment1 Intervention
Patients receive rilzabrutinib 400mg orally twice daily for up to 24 weeks followed by 28 weeks of open label period
Group II: PlaceboPlacebo Group1 Intervention
Patients receive matching placebo 400mg orally twice daily for up to 24 weeks
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 2

Find a Location

Who is running the clinical trial?

Principia Biopharma, a Sanofi CompanyLead Sponsor
7 Previous Clinical Trials
389 Total Patients Enrolled

Media Library

Rilzabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04562766 — Phase 3
Thrombocytopenic Purpura Research Study Groups: Rilzabrutinib, Placebo
Thrombocytopenic Purpura Clinical Trial 2023: Rilzabrutinib Highlights & Side Effects. Trial Name: NCT04562766 — Phase 3
Rilzabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04562766 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you explain the risks associated with Rilzabrutinib?

"There is both efficacy and safety data from multiple rounds of clinical trials, so Rilzabrutinib received a score of 3."

Answered by AI

Are people with the qualifying condition able to enroll in this study at this time?

"That is correct, the information available on clinicaltrials.gov points to this trial currently looking for patients to enroll. The study was first made public on December 14th 2020 with the most recent update happening November 3rd 2022. In total, they are seeking 224 volunteers spread out over 28 different sites."

Answered by AI

What is the cap on recruitment for this experiment?

"The sponsor, Principia Biopharma (a subsidiary of Sanofi), needs to enrol 224 patients that fit the bill. The trial will take place across various sites, with Investigational Site Number 84034 in Atlanta, Georgia and Investigational Site Number 84035 in Salt Lake City, Utah being two locations where data collection will occur."

Answered by AI

In how many places is this trial taking place?

"There are 28 medical facilities across America that are participating in this clinical trial, including sites in Atlanta, Georgia; Salt Lake City, Utah; and Los Angeles, California."

Answered by AI

Who else is applying?

What state do they live in?
How old are they?
What site did they apply to?
Investigational Site Number 84029
What portion of applicants met pre-screening criteria?
Did not meet criteria
~48 spots leftby Jun 2025