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.
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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 12, 2025 (Actual)
- Primary completion
- Jul 23, 2027 (Estimated)
- Completion
- Dec 29, 2028 (Estimated)
- Last update posted
- Oct 15, 2026
2025 – 2028
United States locations
- U.S. sites
- 21
- U.S. states
- 17
- U.S. cities
- 20
| 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 | Clovis | California | 93611 | Recruiting |
| David Geffen School of Medicine at UCLA- Site Number : 8400032 | Los Angeles | California | 90095 | Recruiting |
| MedStar Georgetown University Hospital- Site Number : 8400036 | Washington D.C. | District of Columbia | 20007 | 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 |
| Oregon Health & Science University (OHSU)- Site Number : 8400043 | Portland | Oregon | 97239 | Recruiting |
| Prisma Health- Site Number : 8400051 | Greenville | South Carolina | 29605 | Recruiting |
| University of Tennessee Health Science Center- Site Number : 8400045 | Memphis | Tennessee | 38103 | Recruiting |
| Baylor College of Medicine- Site Number : 8400055 | Houston | Texas | 77030 | Recruiting |
| UT Physicians - Memorial Hermann- Site Number : 8400052 | 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 42 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 Oct 15, 2026 · Synced Nov 9, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06975865 live on ClinicalTrials.gov.