Save

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.

Simpliy with AI

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.

Simplify with AI

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.

Simplify with AI

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

Image related to Primary Immune Thrombocytopenia

Condition: Primary Immune Thrombocytopenia
BIOLOGICAL: PF-06835375
Liverpool, New South Wales, Australia and more
Sponsor: Pfizer

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

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 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 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

Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

No questions submitted. Be the first to ask a question!

You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

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