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Bruton's Tyrosine Kinase (BTK) Inhibitor
Rilzabrutinib for Immune Thrombocytopenia (LUNA 3 Trial)
Phase 3
Recruiting
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])
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
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 belowSelect...
My blood, liver, and kidney tests are within normal ranges.
LUNA 3 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 52 weeks of treatment, 12 months of long term extension and 4 weeks of follow up post last dose
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
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 moreLUNA 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rilzabrutinib
2021
Completed Phase 2
~320
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child needs treatment for ITP as decided by our doctor.I haven't changed my CS or TPO-RA dose significantly in the last 14 days.I am scheduled for surgery during the treatment period.I haven't had blood transfusions or treatments to increase my platelet count in the last 14 days.I have had a solid organ transplant.All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.My B-cell count is normal after rituximab treatment.I have been diagnosed with secondary immune thrombocytopenia.I haven't had cancer that needed chemo or surgery in the last 5 years, except for non-melanoma skin cancer.Your blood platelet count has been consistently low, and no single platelet count has been higher than 35,000/µL in the last 14 days before starting the study drug.My platelet count improved with treatment but didn't last, and I can't tolerate standard ITP therapies.My blood, liver, and kidney tests are within normal ranges.I have never taken rilzabrutinib.I have not received a live vaccine in the last 28 days and do not plan to during the study.Your hemoglobin level is higher than 9 grams per deciliter within a week before the study starts.I have been diagnosed with myelodysplastic syndrome.I haven't taken immunosuppressant drugs (other than corticosteroids) recently.I am over 18 with ITP for more than 3 months, or 12-17 (10-11 in the EU) with ITP for over 6 months.I have not had rituximab or a spleen removal in the last 3 months.I haven't taken any BTK inhibitors (except rilzabrutinib) in the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: Rilzabrutinib
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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?
Illinois
How old are they?
65+
What site did they apply to?
Investigational Site Number 84029
What portion of applicants met pre-screening criteria?
Did not meet criteria
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