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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through end of study (week 20 for cohort 1 and week 24 for cohort 2)

Awards & highlights

Study Summary

This trial is testing a new drug for adults with primary immune thrombocytopenia, a condition where the body doesn't produce enough platelets. The drug will be given as injections, and the trial will assess the safety and effectiveness of the drug.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through end of study (week 20 for cohort 1 and week 24 for cohort 2)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through end of study (week 20 for cohort 1 and week 24 for cohort 2)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through end of study (week 20 for cohort 1 and week 24 for cohort 2) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)

Proportion of participants with change from baseline of circulating B cells

Proportion of participants with change from baseline of circulating cTfh cells

+3 more

Side effects data

From 2022 Phase 1 trial • 74 Patients • NCT03334851

33%

Headache

17%

Systemic lupus erythematosus

17%

Arthralgia

17%

Angina pectoris

17%

Vaccination complication

17%

Myalgia

17%

Diarrhoea

17%

Contusion

17%

Abdominal pain lower

17%

Urinary tract infection

17%

Viral infection

17%

Migraine

17%

Dermatitis contact

17%

Spinal osteoarthritis

17%

Erythema

100%

80%

60%

40%

20%

Study treatment Arm

PF-06835375 10 mg SC MAD

PF-06835375 0.03 mg IV SAD

PF-06835375 0.3 mg SC MAD

PF-06835375 3 mg SC MAD

Placebo SC MAD

PF-06835375 1 mg SC MAD

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 3 mg IV SAD

PF-06835375 6 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor

4,570 Previous Clinical Trials

10,915,925 Total Patients Enrolled

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,476 Previous Clinical Trials

8,092,120 Total Patients Enrolled

Media Library

PF-06835375 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05070845 — Phase 2

Thrombocytopenic Purpura Research Study Groups: Open Label PF-06835375 dose 2 Treatment, Open Label PF-06835375 dose 1 Treatment

Thrombocytopenic Purpura Clinical Trial 2023: PF-06835375 Highlights & Side Effects. Trial Name: NCT05070845 — Phase 2

PF-06835375 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05070845 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA cleared PF-06835375 for use?

"Although there is some evidence that PF-06835375 is safe, as it is only a Phase 2 trial, there is no data yet to support its efficacy."

Answered by AI

Could you tell me if this research is only meant for people over 60 years old?

"The standards to be included in this particular study are that patients are aged 18-70. However, if a patient is under 18 there are 26 other trials they could be a part of and if a patient is over 65 there are 112 trials."

Answered by AI

Is this research project also taking place in other countries besides the United States?

"This study is recruiting patients at Mayo Clinic in Florida in Jacksonville, Unity Health Toronto, St. Michael's Hospital in Toronto, Hematology Oncology Associates of Rockland in Nyack, and nine other locations."

Answered by AI

Are individuals needed for this research project?

"The information available on clinicaltrials.gov does suggest that this clinical trial is presently recruiting patients. This clinical trial was initially posted on 2/2/2022 and was most recently updated on 10/26/2022. The clinical trial is recruiting for 40 participants at 9 locations."

Answered by AI

Who meets the screening criteria to participate in this trial?

"The recruitment goal for this clinical trial is 40 patients that have thrombocytopenia and are between 18 and 70 years old. In order to be eligible, potential participants must also meet the following requirements: A formal diagnosis of Primary ITP, an ongoing ITP with platelet counts lower than 50 x 109/L, [No severe bleeding in the month prior or during screening], AND either 3 to 12 months of Persistent ITP or Chronic ITP for over 12 months."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05070845.

All > Thrombocytopenia