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Active, not recruiting Phase 3 Interventional Results available

Study to Evaluate Rilzabrutinib in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP)

ClinicalTrials.gov ID: NCT04562766

Public ClinicalTrials.gov record NCT04562766. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 11:52 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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 identification

NCT ID
NCT04562766
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Principia Biopharma, a Sanofi Company
Industry
Enrollment
232 participants

Conditions and interventions

Interventions

  • Rilzabrutinib Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
10 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 13, 2020
Primary completion
Jan 14, 2025
Completion
Aug 25, 2026
Last update posted
Feb 22, 2026

2020 – 2026

United States locations

U.S. sites
17
U.S. states
12
U.S. cities
16
Facility City State ZIP Site status
University of Southern California_Investigational Site Number 84024 Los Angeles California 90033
UCSF Benioff Children's Hospital San Francisco_Investigational Site Number 84020 San Francisco California 94158
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center_Investigational Site Number 84037 Torrance California 90502
The Oncology Institute of Hope and Innovation_Investigational Site Number 84031 Whittier California 90602
Children's Hospital Colorado_Investigational Site Number 84025 Aurora Colorado 80045
IMMUNOe International Research Centers_Investigational Site Number 84028 Centennial Colorado 80112
ASCLEPES Research Centers_Investigational Site Number 84023 Weeki Wachee Florida 34607
Children's Healthcare of Atlanta_Investigational Site Number 84034 Atlanta Georgia 30322
Rush University Medical Center_Investigational Site Number 84029 Chicago Illinois 60612
University of Louisville - James Graham Brown Cancer Center_Investigational Site Number 84033 Louisville Kentucky 40202
Massachusetts General Hospital Site Number : 84038 Boston Massachusetts 02114
Montefiore Medical Center_Investigational Site Number 84032 The Bronx New York 10461
University Hospitals Cleveland Medical Center Site Number : 84036 Cleveland Ohio 44106
Cleveland Clinic_Investigational Site Number 84026 Cleveland Ohio 44195
The Children's Hospital of Philadelphia (CHOP)_Investigational Site Number 84027 Philadelphia Pennsylvania 19104
University of Utah-Huntsman Cancer Institute_Investigational Site Number 84035 Salt Lake City Utah 84112
University of Washington Medical Centre Site Number : 84041 Seattle Washington 98195

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 138 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04562766, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 22, 2026 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04562766 live on ClinicalTrials.gov.

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