Trials / Recruiting
RecruitingNCT07007962
Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment
A Multi-center, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | rilzabrutinib | Pharmaceutical form:Tablet-Route of administration:Oral |
Timeline
- Start date
- 2025-10-24
- Primary completion
- 2027-11-05
- Completion
- 2028-12-30
- First posted
- 2025-06-06
- Last updated
- 2026-04-03
Locations
20 sites across 7 countries: United States, Austria, France, Hungary, Italy, Poland, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07007962. Inclusion in this directory is not an endorsement.