Actively Recruiting
Phase 2 Study of PF-06835375 Injections for Adults with Moderate to Severe Primary Immune Thrombocytopenia
Led by Pfizer · Updated on 2026-05-12
91
Participants Needed
31
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating PF-06835375, a CXCR5 inhibitor, in adults with moderate to severe primary immune thrombocytopenia ITP, focusing on those with persistent or chronic forms lasting more than 3 months. This Phase 2, open-label, multicenter study aims to understand the safety and effects of PF-06835375 on platelet counts in these participants. Participants receive subcutaneous injections of PF-06835375 monthly. Those in cohort 1 are treated with a lower dose once a month for 3 months during a 12-week period. Participants in cohorts 2, 3, and 4 receive higher doses once a month for 4 months during a 16-week period. The treatment is designed to deplete certain immune cells to sustain platelet count improvements over time. During the study, researchers will monitor platelet counts, responses to treatment, circulating B cells, and circulating T follicular helper cells. Safety is also assessed by tracking adverse events related to the treatment from the start through the end of the study, which lasts up to 20 or 24 weeks depending on the cohort. Participants can expect regular monthly visits for injections and laboratory assessments throughout the treatment periods.
CONDITIONS
Brief Title
Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia
Research Team
P
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