Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
The Efficacy and Safety of Rilzabrutinib in Patients Aged 10 to 65 Years With Sickle-cell Disease
NCT06975865 · View on ClinicalTrials.gov ↗
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.
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 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06975865
The ClinicalTrials.gov registry entry for NCT06975865 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 192 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06975865 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Other, Alabama, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06975865?
The interventions under investigation include: Placebo (DRUG), Rilzabrutinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06975865?
This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.