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NCT06975865 · ClinicalTrials.gov registry record · Phase 3
The Efficacy and Safety of Rilzabrutinib in Patients Aged 10 to 65 Years With Sickle-cell Disease
A Phase 3 study of Sickle Cell Disease, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 192
- Enrollment target
- 20
- Study locations
NCT06975865: Recruiting Phase 3 study of Sickle Cell Disease, sponsored by Sanofi.
NCT06975865 is a Phase 3 study of Sickle Cell Disease that is actively recruiting participants, run by Sanofi. The registered enrollment target is 192 participants, below the 292-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (34% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06975865, a Phase 3 study of Sickle Cell Disease, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 192 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, 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.
Primary Outcome
Calculated from total number of clinical VOC incidents and total number of days during the observation period
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Rilzabrutinib
Study Locations (20)
Other
- Investigational Site Number : 0560003 - Brussels
- Investigational Site Number : 0560002 - Brussels
- Investigational Site Number : 0560001 - Leuven
- Pontifícia Universidade Católica do Rio de Janeiro- Site Number : 0760009 - Rio de Janeiro
- Hospital Samaritano De Sao Paulo- Site Number : 0760005 - São Paulo
- Investigational Site Number : 2500002 - Créteil
- Investigational Site Number : 2500005 - Marseille
Alabama
- University of Alabama at Birmingham- Site Number : 8400003 - Birmingham
California
- University of California San Francisco- Site Number : 8400040 - Fresno
Florida
- Oncology & Hematology Associates of West Broward- Site Number : 8400029 - Coral Springs
Illinois
- University of Illinois-Chicago - College of Medicine- Site Number : 8400054 - Chicago
Louisiana
- Louisiana State University Health Sciences Center - Shreveport- Site Number : 8400037 - Shreveport
Michigan
- University of Michigan Health System - Ann Arbor- Site Number : 8400035 - Ann Arbor
Mississippi
- Southern Specialty Research- Site Number : 8400059 - Flowood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 192 participants |
| Start Date | 2025-08-12 |
| Est. Completion | 2028-12-29 |
| Phase | Phase 3 |
What NCT06975865 shows while recruiting
NCT06975865 is an interventional study that assigns participants to a tested intervention. The registered 192 participants enrollment target is mid-sized for trials with a published cap, below the 292-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (34% lower).
The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06975865 names 20 study sites across 14 states, led by Other, Alabama, California.
Frequently Asked Questions
What is clinical trial NCT06975865 about?
NCT06975865 is a clinical study titled "The Efficacy and Safety of Rilzabrutinib in Patients Aged 10 to 65 Years With Sickle-cell Disease". This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, 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: * Stud...
What is the current status of trial NCT06975865?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 192 participants. The study started on 2025-08-12. Estimated completion is 2028-12-29.
What conditions does trial NCT06975865 study?
This clinical trial studies the following conditions: Sickle Cell Disease.
What interventions are being tested in trial NCT06975865?
The interventions under investigation include: Placebo (DRUG), Rilzabrutinib (DRUG).
Who is sponsoring clinical trial NCT06975865?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06975865 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Sickle Cell Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06975865's enrollment target sits among peer trials
192 37th of 213 higher than 177 of 213 other Sickle Cell Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sickle Cell Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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