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

Phase 2RecruitingNCT05070845

Pfizer91 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Primary Immune Thrombocytopenia

Interventions

PF-06835375BIOLOGICAL

CXCR5 inhibitor

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (31)

Outcomes

Primary Outcomes

Proportion of participants with change from baseline of platelet counts

To evaluate absolute value of platelet count of treated participants

Time frame: baseline through 12 and 16 weeks

Secondary Outcomes

proportion of participants with modified overall response (mOR)

To evaluate the modified overall response of platelet count of treated participants

Time frame: baseline through 12 and 16 weeks

proportion of participants with complete response (CR)

To evaluate the complete response of platelet count of treated participants

Time frame: baseline through 12 and 16 weeks

Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)

Time frame: baseline through end of study (Week 20 for cohort 1 and Week 24 for cohorts 2 and 3)

Proportion of participants with change from baseline of platelet counts

Time frame: baseline to Week 20 and Week 24

Proportion of participants with change from baseline of circulating B cells

Time frame: baseline to Week 20 and Week 24

Proportion of participants with change from baseline of circulating cTfh cells

Time frame: baseline to Week 20 and Week 24

Central Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

East Carolina University

Greenville, North Carolina, United States

RECRUITING

Liverpool Hospital

Liverpool, New South Wales, Australia

RECRUITING

South West Radiology

Liverpool, New South Wales, Australia

RECRUITING

Slade Pharmacy

Mount Kuring-Gai, New South Wales, Australia

RECRUITING

Calvary Mater Newcastle

Waratah, New South Wales, Australia

RECRUITING

Flinders Medical Centre

Bedford Park, South Australia, Australia

RECRUITING

ICON Cancer Centre - Kurralta Park

Kurralta Park, South Australia, Australia

RECRUITING

The Alfred Hospital

Melbourne, Victoria, Australia

RECRUITING

Royal Perth Hospital

Perth, Western Australia, Australia

RECRUITING

Unity Health Toronto, St. Michael's Hospital

Toronto, Ontario, Canada

RECRUITING

...and 21 more locations