At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- PF-06835375 (biological)
- How long the study runs
- Study runs about 78 months (dates as stated)
- About the drug or intervention
- PF-06835375 — biological: CXCR5 inhibitor
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by Pfizer, is looking at the safety and how well a medicine called PF-06835375 works in people with primary immune thrombocytopenia (ITP) — a condition where the immune system lowers platelet counts in the blood. Not stated — ask the trial team for further details about the study aims.
Who can take part
- You have been diagnosed with primary immune thrombocytopenia (ITP).
- Your platelet counts are below 50 x 10^9/L.
- You have had no severe bleeding within one month or during screening.
- You have persistent ITP (lasting 3 to 12 months) or chronic ITP (lasting more than 12 months).
Who may not be able to
- You had a bleeding event of grade 2 or higher on the World Health Organization (WHO) grading scale within 4 weeks before screening.
- You currently have a bleeding event that, in the study doctor's opinion, needs standard treatment, or you need blood or blood products during screening.
- You had your spleen removed within 3 months of joining the study, or you plan to have it removed during the study.
What taking part involves
- • Not stated — ask the trial team what treatment or tests are involved.
Time commitment: Not stated — ask the trial team how long the study lasts and what visits or procedures are involved.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 70 Years
- Who
- All
- Number of participants
- 91
- Started
- 2022-02-02
- Last checked
- 2026-05
Plain English Summary
What is this study?
- • Testing a new treatment for primary immune thrombocytopenia
- • Phase2 - 91 participants
- • 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)
Who can take part?
- • Ages 18 Years to 70 Years
- • Diagnosed with primary immune thrombocytopenia
Where?
- • Cambridge - Addenbrooke's Hospital
- • Plymouth - Derriford Hospital
- • Truro - The Royal Cornwall Hospital
- • London - Hammersmith Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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
More detail
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 received 1 subcutaneous injection of dose 1 every month for 3 months during the 12-week treatment period. Each participant in cohorts 2, 3, or 4 (will) receive(d) subcutaneous injection(s) of dose 2, 3, or 4 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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 70 Years
- Who can join: All genders
What the study is looking for
- ✓Diagnosis of Primary ITP. Ongoing ITP (platelet counts \<50 x 109/L) \[No severe bleeding within 1 month or during...
Who cannot take part
- ✗Splenectomy within 3 months of randomization or planned during the study duration.
See the full criteria
Where Is This Study? (4 UK sites)
Addenbrooke's Hospital
Cambridge CB2 2QQ, United Kingdom
Derriford Hospital
Plymouth Pl6 8DH, United Kingdom
The Royal Cornwall Hospital
Truro TR1 3LJ, United Kingdom
Hammersmith Hospital
London W12 0HS, United Kingdom
How to Get in Touch
Pfizer CT.gov Call Center
Sponsor contactCONTACT