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

Primary Immune Thrombocytopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05070845
• Other study ID #: C1131003
• Secondary ID: 2021-002897-19
• Status: Recruiting
• Phase: Phase 2
• Start date: February 2, 2022
• Est. completion date: March 21, 2025

Study information

• Verified date: January 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 61
• Est. completion date: March 21, 2025
• Est. primary completion date: March 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Primary Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

Biological:
• PF-06835375
CXCR5 inhibitor

Locations

Country	Name	City	State
Australia	Flinders Medical Centre	Bedford Park	South Australia
Australia	St George Hospital	Kogarah	New South Wales
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	South West Radiology	Liverpool	New South Wales
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Slade Pharmacy	Mount Kuring-Gai	New South Wales
Australia	Royal Perth Hospital	Perth	Western Australia
Australia	Calvary Mater Newcastle	Waratah	New South Wales
Canada	McGill University Health Centre	Montreal	Quebec
Canada	Unity Health Toronto, St. Michael's Hospital	Toronto	Ontario
Czechia	Fakultni nemocnice Hradec Kralove	Hradec Kralove
Czechia	Vseobecna fakultni nemocnice v Praze	Praha 2
Hungary	Semmelweis University	Budapest
Hungary	Petz Aladár Egyetemi Oktató Kórház	Györ
Hungary	Somogy Megyei Kaposi Mór Oktató Kórház	Kaposvár	Somogy
Hungary	Pécsi Tudományegyetem Klinikai Központ	Pécs	Baranya
Poland	InterHem	Bialystok
Poland	Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Pratia Onkologia Katowice	Katowice
Poland	Uniwersytecki Szpital Kliniczny w Poznaniu	Poznan
Poland	Centrum Medyczne Pratia Poznan	Skorzewo	Wielkopolskie
Poland	Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku	Wroclaw
United Kingdom	Derriford Hospital	Plymouth	Devon
United States	American Oncology Partners of Maryland, PA	Bethesda	Maryland
United States	American Oncology Partners of MD, PA	Bethesda	Maryland
United States	American Oncology Partners of Maryland, PA	Germantown	Maryland
United States	East Carolina University	Greenville	North Carolina
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	Hematology Oncology Associates of Rockland	Nyack	New York
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Czechia,  Hungary,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with change from baseline of platelet counts	To evaluate absolute value of platelet count of treated participants	baseline through 12 and 16 weeks
Secondary	proportion of participants with modified overall response (mOR)	To evaluate the modified overall response of platelet count of treated participants	baseline through 12 and 16 weeks
Secondary	proportion of participants with complete response (CR)	To evaluate the complete response of platelet count of treated participants	baseline through 12 and 16 weeks
Secondary	Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)		baseline through end of study (Week 20 for cohort 1 and Week 24 for cohort 2)
Secondary	Proportion of participants with change from baseline of platelet counts		baseline to Week 20 and Week 24
Secondary	Proportion of participants with change from baseline of circulating B cells		baseline to Week 20 and Week 24
Secondary	Proportion of participants with change from baseline of circulating cTfh cells		baseline to Week 20 and Week 24

External Links

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