Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia
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
2 other identifiers
interventional
91
7 countries
16
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2022
Longer than P75 for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2021
CompletedFirst Posted
Study publicly available on registry
October 7, 2021
CompletedStudy Start
First participant enrolled
February 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 2, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 2, 2028
May 5, 2026
May 1, 2026
6.5 years
September 27, 2021
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of participants with change from baseline of platelet counts
To evaluate absolute value of platelet count of treated participants
baseline through 12 and 16 weeks
Secondary Outcomes (6)
proportion of participants with modified overall response (mOR)
baseline through 12 and 16 weeks
proportion of participants with complete response (CR)
baseline through 12 and 16 weeks
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
baseline through end of study (Week 20 for cohort 1 and Week 24 for cohorts 2 and 3)
Proportion of participants with change from baseline of platelet counts
baseline to Week 20 and Week 24
Proportion of participants with change from baseline of circulating B cells
baseline to Week 20 and Week 24
- +1 more secondary outcomes
Study Arms (4)
Open Label PF-06835375 dose 1 Treatment
EXPERIMENTALsubcutaneous injection once monthly for 3 months
Open Label PF-06835375 dose 2 Treatment
EXPERIMENTALsubcutaneous injection once monthly for 4 months
Open Label PF-06835375 dose 3 Treatment
EXPERIMENTALsubcutaneous injection once monthly for 4 months
Open Label PF-06835375 dose 4 Treatment
EXPERIMENTALsubcutaneous injections once monthly for 4 months
Interventions
CXCR5 inhibitor
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (16)
East Carolina University
Greenville, North Carolina, 27834, United States
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
Slade Pharmacy
Mount Kuring-Gai, New South Wales, 2080, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
ICON Cancer Centre - Kurralta Park
Kurralta Park, South Australia, 5037, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 12808, Czechia
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár, Somogy County, 7400, Hungary
Petz Aladár Egyetemi Oktató Kórház
Győr, 9024, Hungary
Tolna Varmegyei Balassa Janos Korhaz
Szekszárd, 7100, Hungary
Komárom-Esztergom Vármegyei Szent Borbála Kórház
Tatabánya, H-2800, Hungary
AIDPORT Sp. z o.o.
Skórzewo, Greater Poland Voivodeship, 60-185, Poland
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom
Derriford Hospital
Plymouth, Devon, Pl6 8DH, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Masking Details
- open label
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2021
First Posted
October 7, 2021
Study Start
February 2, 2022
Primary Completion (Estimated)
August 2, 2028
Study Completion (Estimated)
August 2, 2028
Last Updated
May 5, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
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.