C1131003


C1131003: Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia

Trial summary:

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 will receive 1 subcutaneous injection of dose 1 every month for 3 months during the 12-week treatment period. And each participant in cohorts 2 and 3 will receive 1 subcutaneous injection of dose 2 or 3 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.

Receptor status / problem studied:

Inclusion criteria

1) 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

1) 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

2) Splenectomy within 3 months of randomization or planned during the study duration.

View more trial information

Open for recruitment

Trial Title

C1131003

Diagnosis

Immune Thrombocytopenia (ITP)

Type of trial

Pharmaceutical

Type of treatement

Medical Oncology

Phase

II

Investigators

Principal Investigator
View all clinical trials

Search

Contact us
Become a patient