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Clinical Trial 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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05070845
Study type Interventional
Source Pfizer
Contact Pfizer CT.gov Call Center
Phone 1-800-718-1021
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date November 14, 2021
Completion date October 22, 2023

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