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

April 23, 2024 updated by: Pfizer

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

61

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • Recruiting
        • St George Hospital
      • Liverpool, New South Wales, Australia, 2170
        • Recruiting
        • Liverpool Hospital
      • Liverpool, New South Wales, Australia, 2170
        • Recruiting
        • South West Radiology
      • Mount Kuring-Gai, New South Wales, Australia, 2080
        • Recruiting
        • Slade Pharmacy
      • Waratah, New South Wales, Australia, 2298
        • Recruiting
        • Calvary Mater Newcastle
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Recruiting
        • Flinders Medical Centre
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • The Alfred Hospital
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Recruiting
        • Royal Perth Hospital
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • Recruiting
        • Unity Health Toronto, St. Michael's Hospital
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre
  • Czechia
      • Hradec Kralove, Czechia, 500 05
        • Recruiting
        • Fakultni Nemocnice Hradec Kralove
      • Praha 2, Czechia, 12808
        • Recruiting
        • Vseobecna fakultni nemocnice v Praze
  • Hungary
      • Budapest, Hungary, 1088
        • Recruiting
        • Semmelweis University
      • Györ, Hungary, 9024
        • Recruiting
        • Petz Aladár Egyetemi Oktató Kórház
    • Baranya
      • Pécs, Baranya, Hungary, 7624
        • Recruiting
        • Pécsi Tudományegyetem Klinikai Központ
    • Somogy
      • Kaposvár, Somogy, Hungary, 7400
        • Recruiting
        • Somogy Megyei Kaposi Mór Oktató Kórház
  • Poland
      • Bialystok, Poland, 15-732
        • Recruiting
        • InterHem
      • Gdansk, Poland, 80-214
        • Active, not recruiting
        • Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne
      • Katowice, Poland, 40-519
        • Recruiting
        • Pratia Onkologia Katowice
      • Poznan, Poland, 60-569
        • Recruiting
        • Uniwersytecki Szpital Kliniczny w Poznaniu
      • Wroclaw, Poland, 50-367
        • Recruiting
        • Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku
    • Wielkopolskie
      • Skorzewo, Wielkopolskie, Poland, 60-185
        • Recruiting
        • Centrum Medyczne Pratia Poznan
  • United Kingdom
    • Devon
      • Plymouth, Devon, United Kingdom, Pl6 8DH
        • Not yet recruiting
        • Derriford Hospital
  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic in Florida
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Recruiting
        • American Oncology Partners of Maryland, PA
      • Bethesda, Maryland, United States, 20817
        • Recruiting
        • American Oncology Partners of MD, PA
      • Germantown, Maryland, United States, 20874
        • Recruiting
        • American Oncology Partners of Maryland, PA
    • New York
      • Nyack, New York, United States, 10960
        • Not yet recruiting
        • Hematology Oncology Associates of Rockland
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • East Carolina University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open Label PF-06835375 dose 1 Treatment
subcutaneous injection once monthly for 3 months
Biological: PF-06835375
CXCR5 inhibitor
Experimental: Open Label PF-06835375 dose 2 Treatment
subcutaneous injection once monthly for 4 months
Biological: PF-06835375
CXCR5 inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with change from baseline of platelet counts
Time Frame: baseline through 12 and 16 weeks
To evaluate absolute value of platelet count of treated participants
baseline through 12 and 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
proportion of participants with modified overall response (mOR)
Time Frame: baseline through 12 and 16 weeks
To evaluate the modified overall response of platelet count of treated participants
baseline through 12 and 16 weeks
proportion of participants with complete response (CR)
Time Frame: baseline through 12 and 16 weeks
To evaluate the complete response of platelet count of treated participants
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 cohort 2)
baseline through end of study (Week 20 for cohort 1 and Week 24 for cohort 2)
Proportion of participants with change from baseline of platelet counts
Time Frame: baseline to Week 20 and Week 24
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
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
baseline to Week 20 and Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2022

Primary Completion (Estimated)

May 17, 2027

Study Completion (Estimated)

May 17, 2027

Study Registration Dates

First Submitted

September 27, 2021

First Submitted That Met QC Criteria

September 27, 2021

First Posted (Actual)

October 7, 2021

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C1131003
  • 2021-002897-19 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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