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

Conditions

• Primary Immune Thrombocytopenia

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• PF-06835375 — BIOLOGICAL
  CXCR5 inhibitor

Study Details

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

Key Dates

Start date

Feb 2, 2022

Status verified

May 2026

Primary completion

Aug 2, 2028

Completion

Aug 2, 2028

Study Design

Enrollment

91 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

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

Primary Outcome Measure

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

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (1)

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