AN INTERVENTIONAL PHASE 2, OPEN-LABEL, ONE-ARM, MULTI-CENTER STUDY TO EVALUATE SAFETY AND EFFICACY OF PF-06835375 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE PRIMARY IMMUNE THROMBOCYTOPENIA
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- STATUS
- Recruiting
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- End date
- Oct 22, 2023
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- participants needed
- 40
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- sponsor
- Pfizer
Summary
This is a Phase 2, open-label, single arm, multicenter, multiple subcutaneous injection, safety and efficacy study of PF-06835375 in adult participants with primary immune thrombocytopenia (ITP). This study will focus on participants with persistent (>3 months and ≤12 months), or chronic (>12 months) ITP
Description
This study is designed to elucidate the effects of PF-06835375 on platelet counts in participants with moderate to severe primary ITP. Based on the experience with other B-cells depleting agents, it is expected that the platelet counts will increase following a standard treatment as evidenced in rituximab efficacy data in the treatment of ITP.3,7,24-26 Each participant will receive 1 subcutaneous injection every month for 3 months during the 12 week treatment period. This should provide sufficient levels of exposure and depletion of CXCR5 positive cells to sustain the effects of PF-06835375 during the 12 week treatment period. Additional depletion of Tfh cells may provide sustained increase in platelet count following the last treatment at Week 8.
Details
| Condition | Primary Immune Thrombocytopenia |
|---|---|
| Treatment | PF-06835375 |
| Clinical Study Identifier | NCT05070845 |
| Sponsor | Pfizer |
| Last Modified on | 24 October 2022 |
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