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

Primary Purpose

Primary Immune Thrombocytopenia

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PF-06835375
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Immune Thrombocytopenia focused on measuring ITP, platelets

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic in FloridaRecruiting
  • American Oncology Partners of Maryland, PARecruiting
  • American Oncology Partners of MD, PARecruiting
  • American Oncology Partners of Maryland, PARecruiting
  • Hematology Oncology Associates of Rockland
  • East Carolina UniversityRecruiting
  • Thomas Jefferson UniversityRecruiting
  • St. George HospitalRecruiting
  • Liverpool HospitalRecruiting
  • South West RadiologyRecruiting
  • Slade PharmacyRecruiting
  • Calvary Mater NewcastleRecruiting
  • Flinders Medical CentreRecruiting
  • The Alfred HospitalRecruiting
  • Royal Perth HospitalRecruiting
  • Unity Health Toronto, St. Michael's HospitalRecruiting
  • McGill University Health CentreRecruiting
  • Fakultni nemocnice Hradec KraloveRecruiting
  • Vseobecna fakultni nemocnice v PrazeRecruiting
  • Pécsi Tudományegyetem Klinikai KözpontRecruiting
  • Somogy Megyei Kaposi Mór Oktató KórházRecruiting
  • Semmelweis EgyetemRecruiting
  • Petz Aladár Egyetemi Oktató KórházRecruiting
  • Centrum Medyczne Pratia PoznańRecruiting
  • InterHemRecruiting
  • Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne
  • Pratia Onkologia KatowiceRecruiting
  • Uniwersytecki Szpital Kliniczny w PoznaniuRecruiting
  • Klinika Hematologii, Nowotworow Krwi i Transplantacji SzpikuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Open Label PF-06835375 dose 1 Treatment

Open Label PF-06835375 dose 2 Treatment

Arm Description

subcutaneous injection once monthly for 3 months

subcutaneous injection once monthly for 4 months

Outcomes

Primary Outcome Measures

Proportion of participants with change from baseline of platelet counts
To evaluate absolute value of platelet count of treated participants

Secondary Outcome Measures

proportion of participants with modified overall response (mOR)
To evaluate the modified overall response of platelet count of treated participants
proportion of participants with complete response (CR)
To evaluate the complete response of platelet count of treated participants
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Proportion of participants with change from baseline of platelet counts
Proportion of participants with change from baseline of circulating B cells
Proportion of participants with change from baseline of circulating cTfh cells

Full Information

First Posted
September 27, 2021
Last Updated
September 15, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05070845
Brief Title
Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2022 (Actual)
Primary Completion Date
March 21, 2025 (Anticipated)
Study Completion Date
March 21, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Immune Thrombocytopenia
Keywords
ITP, platelets

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
open label
Allocation
N/A
Enrollment
61 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open Label PF-06835375 dose 1 Treatment
Arm Type
Experimental
Arm Description
subcutaneous injection once monthly for 3 months
Arm Title
Open Label PF-06835375 dose 2 Treatment
Arm Type
Experimental
Arm Description
subcutaneous injection once monthly for 4 months
Intervention Type
Biological
Intervention Name(s)
PF-06835375
Intervention Description
CXCR5 inhibitor
Primary Outcome Measure Information:
Title
Proportion of participants with change from baseline of platelet counts
Description
To evaluate absolute value of platelet count of treated participants
Time Frame
baseline through 12 and 16 weeks
Secondary Outcome Measure Information:
Title
proportion of participants with modified overall response (mOR)
Description
To evaluate the modified overall response of platelet count of treated participants
Time Frame
baseline through 12 and 16 weeks
Title
proportion of participants with complete response (CR)
Description
To evaluate the complete response of platelet count of treated participants
Time Frame
baseline through 12 and 16 weeks
Title
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)
Title
Proportion of participants with change from baseline of platelet counts
Time Frame
baseline to Week 20 and Week 24
Title
Proportion of participants with change from baseline of circulating B cells
Time Frame
baseline to Week 20 and Week 24
Title
Proportion of participants with change from baseline of circulating cTfh cells
Time Frame
baseline to Week 20 and Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Name
American Oncology Partners of Maryland, PA
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Individual Site Status
Recruiting
Facility Name
American Oncology Partners of MD, PA
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Individual Site Status
Recruiting
Facility Name
American Oncology Partners of Maryland, PA
City
Germantown
State/Province
Maryland
ZIP/Postal Code
20874
Country
United States
Individual Site Status
Recruiting
Facility Name
Hematology Oncology Associates of Rockland
City
Nyack
State/Province
New York
ZIP/Postal Code
10960
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Individual Site Status
Recruiting
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Name
St. George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Individual Site Status
Recruiting
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Individual Site Status
Recruiting
Facility Name
South West Radiology
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Individual Site Status
Recruiting
Facility Name
Slade Pharmacy
City
Mount Kuring-Gai
State/Province
New South Wales
ZIP/Postal Code
2080
Country
Australia
Individual Site Status
Recruiting
Facility Name
Calvary Mater Newcastle
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Individual Site Status
Recruiting
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Unity Health Toronto, St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Individual Site Status
Recruiting
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
ZIP/Postal Code
12808
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Pécsi Tudományegyetem Klinikai Központ
City
Pécs
State/Province
Baranya
ZIP/Postal Code
7624
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Somogy Megyei Kaposi Mór Oktató Kórház
City
Kaposvár
State/Province
Somogy
ZIP/Postal Code
7400
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Petz Aladár Egyetemi Oktató Kórház
City
Györ
ZIP/Postal Code
9024
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Pratia Poznań
City
Skorzewo
State/Province
Wielkopolskie
ZIP/Postal Code
60-185
Country
Poland
Individual Site Status
Recruiting
Facility Name
InterHem
City
Bialystok
ZIP/Postal Code
15-732
Country
Poland
Individual Site Status
Recruiting
Facility Name
Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Pratia Onkologia Katowice
City
Katowice
ZIP/Postal Code
40-519
Country
Poland
Individual Site Status
Recruiting
Facility Name
Uniwersytecki Szpital Kliniczny w Poznaniu
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Individual Site Status
Recruiting
Facility Name
Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku
City
Wroclaw
ZIP/Postal Code
50-367
Country
Poland
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C1131003
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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