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

Last updated: October 23, 2024
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

2

Condition

Immune Thrombocytopenia (Itp)

Idiopathic Thrombocytopenic Purpura (Itp)

Immune (Idiopathic) Thrombocytopenic Purpura (Itp)

Treatment

PF-06835375

Clinical Study ID

NCT05070845
C1131003
2021-002897-19
2023-509338-21-00
  • Ages 18-70
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Bleeding event according to the WHO grading scale ≥2 occurring ≤4 weeks prior toscreen OR a current bleeding event that, in the opinion of the investigator,requires treatment with standard of care therapy OR require blood or blood productsduring screening

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

Study Design

Total Participants: 61
Treatment Group(s): 1
Primary Treatment: PF-06835375
Phase: 2
Study Start date:
February 02, 2022
Estimated Completion Date:
October 27, 2026

Study 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 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.

Connect with a study center

  • Clinical Research Unit Haematology, Division of Cancer Services, St. George Hospital

    Kogarah, New South Wales 2217
    Australia

    Active - Recruiting

  • St George Hospital

    Kogarah, New South Wales 2217
    Australia

    Active - Recruiting

  • St. George Hospital

    Kogarah, New South Wales 2217
    Australia

    Active - Recruiting

  • Liverpool Hospital

    Liverpool, New South Wales 2170
    Australia

    Active - Recruiting

  • South West Radiology

    Liverpool, New South Wales 2170
    Australia

    Active - Recruiting

  • Slade Pharmacy

    Mount Kuring-Gai, New South Wales 2080
    Australia

    Active - Recruiting

  • Calvary Mater Newcastle

    Waratah, New South Wales 2298
    Australia

    Active - Recruiting

  • Flinders Medical Centre

    Bedford Park, South Australia 5042
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Royal Perth Hospital

    Perth, Western Australia 6000
    Australia

    Active - Recruiting

  • Unity Health Toronto, St. Michael's Hospital

    Toronto, Ontario M5B 1W8
    Canada

    Active - Recruiting

  • McGill University Health Centre

    Montreal, Quebec H4A 3J1
    Canada

    Active - Recruiting

  • Fakultni nemocnice Hradec Kralove

    Hradec Kralove, 500 05
    Czechia

    Active - Recruiting

  • Vseobecna fakultni nemocnice v Praze

    Praha 2, 12808
    Czechia

    Active - Recruiting

  • Pécsi Tudományegyetem Klinikai Központ

    Pécs, Baranya 7624
    Hungary

    Active - Recruiting

  • Somogy Megyei Kaposi Mór Oktató Kórház

    Kaposvár, Somogy 7400
    Hungary

    Active - Recruiting

  • Semmelweis Egyetem

    Budapest, 1088
    Hungary

    Active - Recruiting

  • Semmelweis University

    Budapest, 1088
    Hungary

    Active - Recruiting

  • Petz Aladár Egyetemi Oktató Kórház

    Györ, 9024
    Hungary

    Active - Recruiting

  • Centrum Medyczne Pratia Poznań

    Skorzewo, Wielkopolskie 60-185
    Poland

    Active - Recruiting

  • InterHem

    Bialystok, 15-732
    Poland

    Active - Recruiting

  • Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214
    Poland

    Site Not Available

  • Pratia Onkologia Katowice

    Katowice, 40-519
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan, 60-569
    Poland

    Active - Recruiting

  • Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku

    Wroclaw, 50-367
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

    Wroclaw, 50-367
    Poland

    Active - Recruiting

  • Derriford Hospital

    Plymouth, Devon Pl6 8DH
    United Kingdom

    Active - Recruiting

  • Mayo Clinic in Florida

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • American Oncology Partners of MD, PA

    Bethesda, Maryland 20817
    United States

    Active - Recruiting

  • American Oncology Partners of Maryland, PA

    Bethesda, Maryland 20817
    United States

    Active - Recruiting

  • American Oncology Partners of Maryland, PA

    Germantown, Maryland 20874
    United States

    Active - Recruiting

  • Hematology Oncology Associates of Rockland

    Nyack, New York 10960
    United States

    Site Not Available

  • East Carolina University

    Greenville, North Carolina 27834
    United States

    Active - Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.