RecruitingPhase 2NCT05070845
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
Sponsor
Pfizer
Enrollment
91 participants
Start Date
Feb 2, 2022
Study Type
INTERVENTIONAL
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
Eligibility
Min Age: 18 YearsMax Age: 70 Years
Inclusion Criteria1
- 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 Criteria2
- 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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Interventions
BIOLOGICALPF-06835375
CXCR5 inhibitor
Locations(31)
View Full Details on ClinicalTrials.gov
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NCT05070845