Clinical Trial

Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment

Study acronym: LUNA 4
Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
This is a multinational, open label, single arm study that will evaluate the impact of early multi-immune modulation with rilzabrutinib in adult ITP patients who failed first-line treatment. The study includes a screening period (up to 8 weeks), a primary analysis period (up to 28 weeks), a long-term extension period for selected participants (28 weeks) and a 24-week follow-up period only for eligible participants.
Protocol Amendment History 4 changes
notable Trial sites expanded: 30 -> 36 locations 2026-06-23
notable Trial sites expanded: 24 -> 30 locations 2026-05-28
notable Trial sites expanded: 20 -> 24 locations 2026-05-02
notable Trial sites expanded: 10 -> 20 locations 2026-04-04
Trial Details
NCT Number NCT07007962
Lead Sponsor Sanofi
Conditions Immune Thrombocytopenia
Enrollment 60 participants
Start Date 2025-10-24
Primary Completion 2027-11-05 (estimated)
Study Completion 2028-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-22