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
- 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.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE2
Study ID
NCT05070845
Intervention or treatment
BIOLOGICAL: PF-06835375
Conditions
- Primary Immune Thrombocytopenia
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Clinical Research Unit Haematology, Division of Cancer Services, St. George Hospital
Select from list below to view details:
Clinical Research Unit Haematology, Division of Cancer Services, St. George Hospital
Kogarah, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
South West Radiology
Liverpool, New South Wales, Australia
Slade Pharmacy
Mount Kuring-Gai, New South Wales, Australia
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Who is running the clinical trial?
Pfizer
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 |
EXPERIMENTAL: Open Label PF-06835375 dose 4 Treatment
| Biological: PF-06835375 |
What is the study measuring?
Primary Outcome
| Measure | Description | 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
| Measure | Description | 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 |
References
Clinical Trials Gov: Safety and Efficacy Study of PF-06835375 in Primary Immune ThrombocytopeniaOther trials to consider
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