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

  • STATUS
    Recruiting
  • End date
    Oct 22, 2023
  • participants needed
    40
  • sponsor
    Pfizer
Updated on 24 October 2022

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 IdentifierNCT05070845
SponsorPfizer
Last Modified on24 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of Primary ITP. Ongoing ITP (platelet counts <50 x 109/L) [No severe bleeding within 1 month or during screening] AND Persistent ITP (3 to 12 months) or Chronic ITP >12 months

Exclusion Criteria

Bleeding event according to the WHO grading scale ≥2 occurring ≤4 weeks prior to screen OR a current bleeding event that, in the opinion of the investigator, requires treatment with standard of care therapy OR require blood or blood products during screening
Splenectomy within 3 months of randomization or planned during the study duration
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