What side effects are associated with this type of intervention?

Common treatments for Thrombocytopenic Purpura (ITP) include thrombopoietin receptor agonists like romiplostim and eltrombopag, and monoclonal antibodies such as rituximab. Romiplostim and eltrombopag can cause side effects like headache, fatigue, and increased risk of thromboembolic events. Bone marrow reticulin formation has also been observed. Rituximab may lead to infusion reactions, infections, and cytopenias. These treatments aim to increase platelet production or reduce platelet destruction, but they come with potential adverse effects that need to be managed under medical supervision.

What prior FDA approvals exist?

The FDA has approved several treatments for Thrombocytopenic Purpura, including thrombopoietin receptor agonists like romiplostim and eltrombopag. Romiplostim is a peptibody that stimulates platelet production, while eltrombopag is a small molecule that also activates the thrombopoietin receptor. Both drugs are used to increase platelet counts in patients with chronic immune thrombocytopenia. Additionally, avatrombopag, another thrombopoietin receptor agonist, has been approved for similar indications. These treatments aim to mitigate platelet destruction or enhance platelet production, aligning with the therapeutic goals of PF-06835375.

What other types of research exist?

Promising alternatives to PF-06835375 for Thrombocytopenic Purpura patients include PF-06741086, which targets the tissue factor pathway inhibitor to increase clotting activity, and RG13965, a platelet fibrinogen receptor antagonist that reduces thrombosis and inhibits platelet aggregation.

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Monoclonal Antibodies

PF-06835375 for Low Platelet Count

Phase 2

Recruiting

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of Primary ITP with ongoing ITP (platelet counts <50 x 10^9/L) [No severe bleeding within 1 month or during screening] AND Persistent ITP (3 to 12 months) or Chronic ITP >12 months

Be older than 18 years old

Must not have

Splenectomy within 3 months of randomization or planned during the study duration.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through 12 and 16 weeks

Awards & highlights

Summary

This trial uses a new injectable medicine called PF-06835375. It targets adults with long-lasting or chronic low platelet counts due to primary immune thrombocytopenia (ITP). The medicine works by reducing specific immune cells to help increase platelet counts.

Who is the study for?

This trial is for adults with primary immune thrombocytopenia (ITP) who have had low platelet counts for more than 3 months. They shouldn't have had severe bleeding in the last month or need blood products during screening, and they can't join if they've had a splenectomy within the past 3 months or plan to have one.

What is being tested?

The study tests PF-06835375 through multiple subcutaneous injections to see if it's safe and effective for treating ITP. It's an open-label Phase 2 trial, meaning both researchers and participants know what treatment is being given.

What are the potential side effects?

Specific side effects of PF-06835375 are not listed here, but common ones may include injection site reactions, increased risk of infections, headaches, nausea, or fatigue. Each person might experience different side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with ITP and my platelet count is below 50, without severe bleeding in the last month.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had my spleen removed recently or will have it removed soon.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through 12 and 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through 12 and 16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 12 and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of participants with change from baseline of platelet counts

Secondary study objectives

proportion of participants with complete response (CR)

proportion of participants with modified overall response (mOR)

Side effects data

From 2022 Phase 1 trial • 74 Patients • NCT03334851

33%

Hypercalciuria

33%

Chest pain

33%

Abdominal pain

33%

Diarrhoea

33%

Nausea

33%

Upper respiratory tract infection

33%

Iron deficiency anaemia

33%

Keratitis

33%

Dyspepsia

33%

Dysphagia

33%

Gastrointestinal disorder

33%

Haemorrhoids

33%

Melaena

33%

Oesophageal stenosis

33%

Urinary tract infection

33%

Muscle strain

33%

Back pain

33%

Device malfunction

33%

Haematuria

33%

Nocturia

33%

Stag horn calculus

100%

80%

60%

40%

20%

Study treatment Arm

PF-06835375 0.03 mg IV SAD

PF-06835375 3 mg SC MAD

Placebo SC MAD

PF-06835375 3 mg IV SAD

Placebo IV SAD

PF-06835375 0.1 mg IV SAD

PF-06835375 0.3 mg IV SAD

PF-06835375 1 mg IV SAD

PF-06835375 6 mg IV SAD

PF-06835375 0.3 mg SC MAD

PF-06835375 1 mg SC MAD

PF-06835375 6 mg SC MAD

PF-06835375 10 mg SC MAD

Trial Design

2Treatment groups

Experimental Treatment

Group I: Open Label PF-06835375 dose 2 TreatmentExperimental Treatment1 Intervention

subcutaneous injection once monthly for 4 months

Group II: Open Label PF-06835375 dose 1 TreatmentExperimental Treatment1 Intervention

subcutaneous injection once monthly for 3 months

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PF-06835375

2017

Completed Phase 1

~80

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Thrombocytopenic Purpura (ITP) include corticosteroids, thrombopoietin receptor agonists, immunosuppressants, and monoclonal antibodies. Corticosteroids work by suppressing the immune system to reduce the destruction of platelets. Thrombopoietin receptor agonists, such as eltrombopag and romiplostim, stimulate the bone marrow to produce more platelets. Immunosuppressants like rituximab target B-cells to decrease the production of antibodies that attack platelets. Monoclonal antibodies, such as those being studied in trials like PF-06835375, are designed to target specific pathways involved in platelet destruction or production, potentially offering a more precise treatment option. These mechanisms are crucial for ITP patients as they help manage platelet counts and reduce the risk of bleeding complications.