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Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia
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.
Study details:
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 cohorts 2 and 3 will receive 1 subcutaneous injection of dose 2 or 3 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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-02-02
Primary completion: 2026-10-27
Study completion finish: 2026-10-27
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT05070845
Intervention or treatment
BIOLOGICAL: PF-06835375
Conditions
- • Primary Immune Thrombocytopenia
Find a site
Closest Location:
Liverpool Hospital
Research sites nearby
Select from list below to view details:
Liverpool Hospital
Liverpool, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Open Label PF-06835375 dose 1 Treatment
| BIOLOGICAL: PF-06835375
|
EXPERIMENTAL: Open Label PF-06835375 dose 2 Treatment
| BIOLOGICAL: PF-06835375
|
EXPERIMENTAL: Open Label PF-06835375 dose 3 Treatment
| BIOLOGICAL: PF-06835375
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
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 outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
proportion of participants with modified overall response (mOR) | To evaluate the modified overall response of platelet count of treated participants | baseline through 12 and 16 weeks |
proportion of participants with complete response (CR) | To evaluate the complete response of platelet count of treated participants | baseline through 12 and 16 weeks |
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) | Not Specified | 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 | Not Specified | baseline to Week 20 and Week 24 |
Proportion of participants with change from baseline of circulating B cells | Not Specified | baseline to Week 20 and Week 24 |
Proportion of participants with change from baseline of circulating cTfh cells | Not Specified | baseline to Week 20 and Week 24 |
Frequently Asked Questions
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