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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 : June 1, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 27, 2021
First Posted Date  ICMJE October 7, 2021
Last Update Posted Date June 1, 2023
Actual Study Start Date  ICMJE February 2, 2022
Estimated Primary Completion Date March 21, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2023)		 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
Original Primary Outcome Measures  ICMJE
 (submitted: September 27, 2021)		 Change from baseline of platelet counts at Week 12 [ Time Frame: baseline through 12 weeks ]
To evaluate absolute value of platelet count of treated participants
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2023)
  • 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
  • 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
  • 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) ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2021)
  • proportion of participants with modified overall response (mOR) at Week 12 [ Time Frame: baseline through 12 weeks ]
    To evaluate the modified overall response of platelet count of treated participants
  • proportion of participants with complete response (CR) at Week 12 [ Time Frame: baseline through 12 weeks ]
    To evaluate the complete response of platelet count of treated participants
  • Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) [ Time Frame: baseline through end of study (Week 20) ]
  • Change from baseline of platelet counts [ Time Frame: baseline to Week 20 ]
  • Change from baseline of circulating B cells [ Time Frame: baseline to Week 20 ]
  • Change from baseline of circulating cTfh cells [ Time Frame: baseline to Week 20 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia
Official Title  ICMJE 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
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
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description:
open label
Primary Purpose: Treatment
Condition  ICMJE Primary Immune Thrombocytopenia
Intervention  ICMJE Biological: PF-06835375
CXCR5 inhibitor
Study Arms  ICMJE
  • Experimental: Open Label PF-06835375 dose 1 Treatment
    subcutaneous injection once monthly for 3 months
    Intervention: Biological: PF-06835375
  • Experimental: Open Label PF-06835375 dose 2 Treatment
    subcutaneous injection once monthly for 4 months
    Intervention: Biological: PF-06835375
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 25, 2023)		 61
Original Estimated Enrollment  ICMJE
 (submitted: September 27, 2021)		 40
Estimated Study Completion Date  ICMJE March 21, 2025
Estimated Primary Completion Date March 21, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE Australia,   Canada,   Czechia,   Hungary,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05070845
Other Study ID Numbers  ICMJE C1131003
2021-002897-19 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Current Responsible Party Pfizer
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Pfizer
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP