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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05070845




Registration number
NCT05070845
Ethics application status
Date submitted
27/09/2021
Date registered
7/10/2021
Date last updated
26/10/2024

Titles & IDs
Public title
Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia
Scientific 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
Secondary ID [1] 0 0
2023-509338-21-00
Secondary ID [2] 0 0
C1131003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Immune Thrombocytopenia 0 0
Condition category
Condition code
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - PF-06835375

Experimental: Open Label PF-06835375 dose 1 Treatment - subcutaneous injection once monthly for 3 months

Experimental: Open Label PF-06835375 dose 2 Treatment - subcutaneous injection once monthly for 4 months

Experimental: Open Label PF-06835375 dose 3 Treatment - subcutaneous injection once monthly for 4 months


Treatment: Other: PF-06835375
CXCR5 inhibitor
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants with change from baseline of platelet counts
Timepoint [1] 0 0
baseline through 12 and 16 weeks
Secondary outcome [1] 0 0
proportion of participants with modified overall response (mOR)
Timepoint [1] 0 0
baseline through 12 and 16 weeks
Secondary outcome [2] 0 0
proportion of participants with complete response (CR)
Timepoint [2] 0 0
baseline through 12 and 16 weeks
Secondary outcome [3] 0 0
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Timepoint [3] 0 0
baseline through end of study (Week 20 for cohort 1 and Week 24 for cohorts 2 and 3)
Secondary outcome [4] 0 0
Proportion of participants with change from baseline of platelet counts
Timepoint [4] 0 0
baseline to Week 20 and Week 24
Secondary outcome [5] 0 0
Proportion of participants with change from baseline of circulating B cells
Timepoint [5] 0 0
baseline to Week 20 and Week 24
Secondary outcome [6] 0 0
Proportion of participants with change from baseline of circulating cTfh cells
Timepoint [6] 0 0
baseline to Week 20 and Week 24

Eligibility
Key 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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/10/2026
Actual
Sample size
Target
61
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Clinical Research Unit Haematology, Division of Cancer Services, St. George Hospital - Kogarah
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
South West Radiology - Liverpool
Recruitment hospital [4] 0 0
Slade Pharmacy - Mount Kuring-Gai
Recruitment hospital [5] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [6] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [7] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [8] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2080 - Mount Kuring-Gai
Recruitment postcode(s) [4] 0 0
2298 - Waratah
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment postcode(s) [7] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Canada
State/province [7] 0 0
Quebec
Country [8] 0 0
Czechia
State/province [8] 0 0
Hradec Kralove
Country [9] 0 0
Czechia
State/province [9] 0 0
Praha 2
Country [10] 0 0
Hungary
State/province [10] 0 0
Baranya
Country [11] 0 0
Hungary
State/province [11] 0 0
Somogy
Country [12] 0 0
Hungary
State/province [12] 0 0
Budapest
Country [13] 0 0
Hungary
State/province [13] 0 0
Györ
Country [14] 0 0
Poland
State/province [14] 0 0
Wielkopolskie
Country [15] 0 0
Poland
State/province [15] 0 0
Bialystok
Country [16] 0 0
Poland
State/province [16] 0 0
Gdansk
Country [17] 0 0
Poland
State/province [17] 0 0
Katowice
Country [18] 0 0
Poland
State/province [18] 0 0
Poznan
Country [19] 0 0
Poland
State/province [19] 0 0
Wroclaw
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Devon

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT05070845
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Country 0 0
Phone 0 0
1-800-718-1021
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05070845