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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05070845
Recruitment Status : Recruiting
First Posted : October 7, 2021
Last Update Posted : April 18, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Primary Immune Thrombocytopenia Biological: PF-06835375 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 61 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: open label
Primary Purpose: Treatment
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
Actual Study Start Date : February 2, 2022
Estimated Primary Completion Date : March 21, 2025
Estimated Study Completion Date : March 21, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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) ]
  4. Proportion of participants with change from baseline of platelet counts [ Time Frame: baseline to Week 20 and Week 24 ]
  5. Proportion of participants with change from baseline of circulating B cells [ Time Frame: baseline to Week 20 and Week 24 ]
  6. Proportion of participants with change from baseline of circulating cTfh cells [ Time Frame: baseline to Week 20 and Week 24 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05070845


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05070845    
Other Study ID Numbers: C1131003
2021-002897-19 ( EudraCT Number )
First Posted: October 7, 2021    Key Record Dates
Last Update Posted: April 18, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
ITP
platelets
Additional relevant MeSH terms:
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Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
 Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations