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NCT04562766 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate Rilzabrutinib in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP)
A Phase 3 study of Immune Thrombocytopenia, sponsored by Principia Biopharma, a Sanofi Company.
- Active
- Registry status
- Phase 3
- Development phase
- 232
- Enrollment target
- 20
- Study locations
NCT04562766 is a Phase 3 study of Immune Thrombocytopenia that is active but no longer recruiting, run by Principia Biopharma, a Sanofi Company. The registered enrollment target is 232 participants, above the 85-participant average among 6 other Immune Thrombocytopenia trials with a reported enrollment target (173% higher). The trial reports 20 study locations across 14 states.
The verdict
NCT04562766, a Phase 3 study of Immune Thrombocytopenia, is active but no longer recruiting, sponsored by Principia Biopharma, a Sanofi Company.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 232 participants
- Enrollment target
- 20
- Study locations
Study Summary
This was a randomized, double-blind study of rilzabrutinib in patients with persistent or chronic ITP, with an average platelet count of \<30,000/μL (and no single platelet count \>35,000/μL) on two counts at least 5 days apart in the 14 days before treatment begins. Patients received rilzabrutinib or placebo 400mg twice daily. For each patient, the study lasted up to 60 weeks from the start of the Screening Period to the End of Study (EOS) visit. This included Screening (up to 4 weeks) through a 12 to 24-week Blinded Treatment Period followed by a 28-week Open-Label Period. Followed by a 4-week post dose follow-up. For adult participants, the maximum duration of the long-term extension (LTE) period was 12 months from the date of the last adult participant to enter the LTE. For pediatric participants, the maximum duration of the LTE period was 12 months from the date of the last pediatric participant to enter the LTE.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Rilzabrutinib
Study Locations (20)
California
- University of Southern California_Investigational Site Number 84024 - Los Angeles
- UCSF Benioff Children's Hospital San Francisco_Investigational Site Number 84020 - San Francisco
- Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center_Investigational Site Number 84037 - Torrance
- The Oncology Institute of Hope and Innovation_Investigational Site Number 84031 - Whittier
Colorado
- Children's Hospital Colorado_Investigational Site Number 84025 - Aurora
- IMMUNOe International Research Centers_Investigational Site Number 84028 - Centennial
Ohio
- University Hospitals Cleveland Medical Center Site Number : 84036 - Cleveland
- Cleveland Clinic_Investigational Site Number 84026 - Cleveland
Buenos Aires
- Investigational Site Number : 3206 - Capital Federal
- Investigational Site Number : 3211 - La Plata
Florida
- ASCLEPES Research Centers_Investigational Site Number 84023 - Weeki Wachee
Georgia
- Children's Healthcare of Atlanta_Investigational Site Number 84034 - Atlanta
Illinois
- Rush University Medical Center_Investigational Site Number 84029 - Chicago
Kentucky
- University of Louisville - James Graham Brown Cancer Center_Investigational Site Number 84033 - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 232 participants |
| Start Date | 2020-12-14 |
| Est. Completion | 2026-08-26 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04562766
The ClinicalTrials.gov registry entry for NCT04562766 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 232 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 85-participant average among 6 other Immune Thrombocytopenia trials with a reported enrollment target (173% higher). The listed sponsor is Principia Biopharma, a Sanofi Company, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Immune Thrombocytopenia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04562766 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Colorado, Ohio.
Frequently Asked Questions
What is clinical trial NCT04562766 about?
NCT04562766 is a clinical study titled "Study to Evaluate Rilzabrutinib in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP)". This was a randomized, double-blind study of rilzabrutinib in patients with persistent or chronic ITP, with an average platelet count of \<30,000/μL (and no single platelet count \>35,000/μL) on two counts at least 5 days apart in the 14 days before treatment begins. Patients received rilzabrutinib ...
What is the current status of trial NCT04562766?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 232 participants. The study started on 2020-12-14. Estimated completion is 2026-08-26.
What conditions does trial NCT04562766 study?
This clinical trial studies the following conditions: Immune Thrombocytopenia.
What interventions are being tested in trial NCT04562766?
The interventions under investigation include: Placebo (DRUG), Rilzabrutinib (DRUG).
Who is sponsoring clinical trial NCT04562766?
This trial is sponsored by Principia Biopharma, a Sanofi Company, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04562766 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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