The Efficacy and Safety of Rilzabrutinib in Participants Aged 10 to 65 Years With Sickle-cell Disease
Public ClinicalTrials.gov record NCT06975865. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Flexible-adaptive, Group Sequential Study to Evaluate the Efficacy and Safety of Rilzabrutinib in Participants Aged 10 to 65 Years With Sickle-cell Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, flexible-adaptive, group-sequential study (Part A), followed by an open-label LTE period (Part B) to investigate the efficacy, and safety of rilzabrutinib in participants with sickle-cell disease (SCD). Study details include: * Study duration: a 52-week double-blind period (Part A), followed by an open-label LTE period (Part B). Double-blind period has two parts, 50% (adult only) until the interim analysis (a proof-concept part analogous to a phase 2b study), and 50% (adult and children) after the interim analysis. Only the participants who complete double-blind treatment period (Part A) are eligible to continue to the LTE period. The duration of the LTE period (Part B) will be from the first-participant-in (FPI)-LTE (Part B) until the last participant who enters the LTE has completed 52 weeks. * Treatment duration: 52-week double-blind period (Part A); LTE period (Part B) from the (FPI until the last participant who enters the LTE has completed 52 weeks. * Visit frequency: Week visits based on the Schedule of Assessments.
Study identification
- NCT ID
- NCT06975865
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 192 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 10 Years to 65 Years
- 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
- Aug 11, 2025
- Primary completion
- Jul 22, 2027
- Completion
- Dec 28, 2028
- Last update posted
- Jul 28, 2026
2025 – 2028
United States locations
- U.S. sites
- 16
- U.S. states
- 14
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham- Site Number : 8400003 | Birmingham | Alabama | 35233 | Recruiting |
| Phoenix Children's Hospital- Site Number : 8400028 | Phoenix | Arizona | 85016 | Recruiting |
| University of California San Francisco- Site Number : 8400040 | Fresno | California | 93701 | Recruiting |
| Oncology & Hematology Associates of West Broward- Site Number : 8400029 | Coral Springs | Florida | 33065 | Recruiting |
| Sylvester Comprehensive Cancer Center- Site Number : 8400020 | Miami | Florida | 33136 | Recruiting |
| University of Illinois-Chicago - College of Medicine- Site Number : 8400054 | Chicago | Illinois | 60612 | Recruiting |
| Indiana University Health Riley Hospital for Children- Site Number : 8400056 | Indianapolis | Indiana | 46202 | Recruiting |
| Louisiana State University Health Sciences Center - Shreveport- Site Number : 8400037 | Shreveport | Louisiana | 71130 | Recruiting |
| University of Maryland School of Medicine - Baltimore- Site Number : 8400041 | Baltimore | Maryland | 21201 | Recruiting |
| University of Michigan Health System - Ann Arbor- Site Number : 8400035 | Ann Arbor | Michigan | 48109 | Recruiting |
| Southern Specialty Research- Site Number : 8400059 | Flowood | Mississippi | 39232 | Recruiting |
| Richmond University Medical Center- Site Number : 8400038 | Staten Island | New York | 10310 | Recruiting |
| Montefiore Medical Center - Moses Campus- Site Number : 8400057 | The Bronx | New York | 10467 | Recruiting |
| Prisma Health- Site Number : 8400051 | Greenville | South Carolina | 29605 | Recruiting |
| Baylor College of Medicine- Site Number : 8400055 | Houston | Texas | 77030 | Recruiting |
| VCU Massey Cancer Center: Dalton Oncology Clinic- Site Number : 8400012 | Richmond | Virginia | 23298 | Recruiting |
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 37 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06975865, 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 Jul 28, 2026 · Synced Sep 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06975865 live on ClinicalTrials.gov.