Recruiting
Phase 2

PF-06835375

Sponsor:

Pfizer

Code:

NCT05070845

Conditions

Primary Immune Thrombocytopenia

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

PF-06835375

Study Details

Brief 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

Conditions

Primary Immune Thrombocytopenia

Study ID

NCT05070845

Start date

Feb 2, 2022

Status verified date

May, 2026

Completion date

Aug 2, 2028

Anticipated

Primary completion date

Aug 2, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

91 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Open Label PF-06835375 dose 1 Treatment

subcutaneous injection once monthly for 3 months

experimental: Open Label PF-06835375 dose 2 Treatment

subcutaneous injection once monthly for 4 months

experimental: Open Label PF-06835375 dose 3 Treatment

subcutaneous injection once monthly for 4 months

experimental: Open Label PF-06835375 dose 4 Treatment

subcutaneous injections once monthly for 4 months

Interventions

PF-06835375

CXCR5 inhibitor

Primary outcome measure

  • Proportion of participants with change from baseline of platelet counts [ Time Frame: baseline through 12 and 16 weeks ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Locations

East Carolina University

Recruiting

Greenville, North Carolina, United States, 27834

Unity Health Toronto, St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 3J1

More Information

Sponsor

Pfizer

Last update posted

May 12, 2026

Last verified

May, 2026

Keywords

  • ITP
  • platelets

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pfizer on 2026-05-12.