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

NCT05070845 · tracked via the Priya Life Science USA tracker

Sponsor

Pfizer

Phase

Phase 2

Started

2022-02-02

Last updated

2026-05-12

Condition(s) studied

Primary Immune Thrombocytopenia

Investigational drug(s) / intervention(s)

PF-06835375

PF-06835375: CXCR5 inhibitor

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

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.

Primary outcome measure(s)

Proportion of participants with change from baseline of platelet counts — baseline through 12 and 16 weeks
To evaluate absolute value of platelet count of treated participants

Trial sites (31)

Facility	City	Region	Status
East Carolina University	Greenville	North Carolina	Recruiting
Liverpool Hospital	Liverpool	New South Wales	Recruiting
South West Radiology	Liverpool	New South Wales	Recruiting
Slade Pharmacy	Mount Kuring-Gai	New South Wales	Recruiting
Calvary Mater Newcastle	Waratah	New South Wales	Recruiting
Flinders Medical Centre	Bedford Park	South Australia	Recruiting
ICON Cancer Centre - Kurralta Park	Kurralta Park	South Australia	Recruiting
The Alfred Hospital	Melbourne	Victoria	Recruiting
Royal Perth Hospital	Perth	Western Australia	Recruiting
Unity Health Toronto, St. Michael's Hospital	Toronto	Ontario	Recruiting
McGill University Health Centre	Montreal	Quebec	Recruiting
Fakultni nemocnice Hradec Kralove	Hradec Králové	Czechia	Recruiting
Fakultni nemocnice Ostrava	Ostrava - Poruba	Czechia	Recruiting
Fakultni nemocnice Kralovske Vinohrady	Prague	Czechia	Recruiting
Vseobecna fakultni nemocnice v Praze	Prague	Czechia	Recruiting
Pécsi Tudományegyetem Klinikai Központ	Pécs	Baranya	Active Not Recruiting
Somogy Megyei Kaposi Mór Oktató Kórház	Kaposvár	Somogy County	Recruiting
Semmelweis University	Budapest	Hungary	Recruiting
Petz Aladár Egyetemi Oktató Kórház	Győr	Hungary	Recruiting
Tolna Varmegyei Balassa Janos Korhaz	Szekszárd	Hungary	Not Yet Recruiting
Komárom-Esztergom Vármegyei Szent Borbála Kórház	Tatabánya	Hungary	Not Yet Recruiting
AIDPORT Sp. z o.o.	Skórzewo	Greater Poland Voivodeship	Recruiting
InterHem	Bialystok	Poland	Active Not Recruiting
Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne	Gdansk	Poland	Active Not Recruiting
Pratia Onkologia Katowice	Katowice	Poland	Recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu	Poznan	Poland	Active Not Recruiting
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu	Wroclaw	Poland	Recruiting
Addenbrooke's Hospital	Cambridge	Cambridgeshire	Recruiting
Derriford Hospital	Plymouth	Devon	Recruiting
The Royal Cornwall Hospital	Truro	England	Recruiting
Hammersmith Hospital	London	United Kingdom	Recruiting

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Other trials for the same condition

A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids Active, not recruiting

A Study of Patients' Preferences for Primary Immune Thrombocytopenia Treatment Recruiting

A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia Active, not recruiting

A Study of Romiplostim Plus Predniso(lo)ne vs. Predniso(lo)ne Alone for the Treatment of Previously Untreated Primary Immune Thrombocytopenia (ITP) Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05070845 on ClinicalTrials.gov ↗ ← All trials in the USA