The Efficacy and Safety of Rilzabrutinib in Participants Aged 10 to 65 Years With Sickle-cell Disease

ClinicalTrials.gov ID: NCT06975865

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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ClinicalTrials.gov public records Last synced May 4, 2026, 6:33 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 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

Study identification

NCT ID: NCT06975865
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Sanofi; Industry
Enrollment: 192 participants

Conditions and interventions

Conditions

Sickle Cell Disease

Interventions

Placebo Drug
Rilzabrutinib Drug

Drug

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: Apr 30, 2026

2025 – 2028

United States locations

U.S. sites: 14
U.S. states: 13
U.S. cities: 14

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
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 40 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 Apr 30, 2026 · Synced May 4, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06975865 live on ClinicalTrials.gov.

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