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

Sanofi
NCT IDNCT06975865ClinicalTrials.gov data as of Apr 2026
Phase

Phase 3

Target enrollment

192

Study length

about 3.4 years

Ages

10–65

Locations

14 sites in AL, AZ, CA +10

About this study

Researchers are testing a treatment called rilzabrutinib for people with sickle cell disease. The trial will last about 1235 days, starting with a double-blind period of 52 weeks followed by an open-label extension period. Participants who complete the double-blind phase are eligible to continue in the open-label extension.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Take Placebo
  • 2.Take Rilzabrutinib
PhasePhase 3
DrugRilzabrutinib
Routeoral

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low13%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Drug classes

kinase inhibitor

Drug routes

oral (Oral Tablet)

Endpoints

Secondary: Annualized rate of home-managed VOCs as reported in the Sickle Cell Pain Crisis (SCPC) eDiary, Change in fatigue as measured by the PROMIS SF v1.0 Fatigue 13a total score (adults), Change in fatigue as measured by the PedsQL Multidimensional Fatigue Scale total score (pediatric participants), Incidence of treatment emergent adverse events (TEAEs), including serious adverse events (SAEs), adverse events of special interest (AESIs) and adverse events leading to discontinuation