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Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia

PHASE2RECRUITING

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.

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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.

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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.
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    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

    Study type

    TREATMENT

    phase

    Phase

      PHASE2

    trial

    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

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    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/ArmIntervention/Treatment
    EXPERIMENTAL: Open Label PF-06835375 dose 1 Treatment
    • subcutaneous injection once monthly for 3 months
    BIOLOGICAL: PF-06835375
    • CXCR5 inhibitor
    EXPERIMENTAL: Open Label PF-06835375 dose 2 Treatment
    • subcutaneous injection once monthly for 4 months
    BIOLOGICAL: PF-06835375
    • CXCR5 inhibitor
    EXPERIMENTAL: Open Label PF-06835375 dose 3 Treatment
    • subcutaneous injection once monthly for 4 months
    BIOLOGICAL: PF-06835375
    • CXCR5 inhibitor

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Proportion of participants with change from baseline of platelet countsTo evaluate absolute value of platelet count of treated participantsbaseline through 12 and 16 weeks

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    proportion of participants with modified overall response (mOR)To evaluate the modified overall response of platelet count of treated participantsbaseline through 12 and 16 weeks
    proportion of participants with complete response (CR)To evaluate the complete response of platelet count of treated participantsbaseline through 12 and 16 weeks
    Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)Not Specifiedbaseline 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 countsNot Specifiedbaseline to Week 20 and Week 24
    Proportion of participants with change from baseline of circulating B cellsNot Specifiedbaseline to Week 20 and Week 24
    Proportion of participants with change from baseline of circulating cTfh cellsNot Specifiedbaseline to Week 20 and Week 24

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    References

    Clinical Trials Gov: Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia

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