Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment
Recruiting
Phase 3
Interventional Study
Immune Thrombocytopenia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 60 (estimated)
- Sponsor
- Sanofi · Industry
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About This Trial
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 elig…
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
* Male or female participants aged 18 years and older with a documented diagnosis of primary ITP in the medical history
* Participant received at least one course of first-line therapy and had a history of response while on treatment
* Participant has loss of response, relap…
Contacts
Trial Transparency email recommended (Toll free for US & Canada)
800-633-1610
CONTACT