NCT05070845

Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia

AN INTERVENTIONAL PHASE 2, OPEN-LABEL, MULTI-CENTER STUDY TO EVALUATE SAFETY AND EFFICACY OF PF-06835375 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE PRIMARY IMMUNE THROMBOCYTOPENIA

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 91 (estimated)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, open-label, 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

Detailed 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. Each participant in cohort 1 received 1 subcutaneous injection of dose 1 every month for 3 months during the 12-week treatment period. Each participant in cohorts 2, 3, or 4 (will) receive(d) subcutaneous injection(s) of dose 2, 3, or 4 every month for 4 months during the 16-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 treatment period. Additional depletion of Tfh cells may provide sustained increase in platelet count following the last treatment.

Conditions

• Primary Immune Thrombocytopenia

Interventions

Type	Name	Description
BIOLOGICAL	PF-06835375	CXCR5 inhibitor

Timeline

• Start date: 2022-02-02
• Primary completion: 2028-08-02
• Completion: 2028-08-02
• First posted: 2021-10-07
• Last updated: 2026-04-16

Locations

31 sites across 7 countries: United States, Australia, Canada, Czechia, Hungary, Poland, United Kingdom

Regulatory

• FDA-regulated drug study