A Study to Learn About a Medicine Called PF-08154225 in Participants With Autoimmune Diseases

Conditions

• Idiopathic Inflammatory Myositis
• Rheumatoid Arthritis
• Systemic Lupus Erythematosus
• Systemic Sclerosis

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• PF-08154225 — DRUG
  immune-modulating agent

Study Details

The purpose of this study is to learn about the safety and effects of the study medication called PF-08154225 for the potential treatment of autoimmune diseases. An autoimmune disease is a condition that makes a person's immune system attack its healthy cells by mistake. This study is particularly looking at autoimmune diseases called as Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA), Idiopathic Inflammatory Myositis (IIM) or Systemic Sclerosis (SSc). This study is divided into 3 parts: Part 1a, Part 1b and Part 2. Parts 1a and 1b are seeking participants with Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis and Part 2 with also Idiopathic Inflammatory Myositis (IIM) or Systemic Sclerosis (SSc). Participants can take part only in one part of the study. All participants in this study will receive PF-08154225 at the study clinic. In Part 1a participants will receive single administration of PF-08154225 after which they will be observed at the study clinic during regular visits through week 16 or longer. In Part 1b the participants will receive multiple administration of PF-08154225 after which they will be monitored in similar a manner as in Part 1a through week 24 or longer. In Part 2 participants will receive multiple administrations of PF-08154225. After the last injection they will be monitored for safety through week 52 or longer.

Key Dates

First listed

Aug 24, 2026

Start date

Sep 10, 2026

Status verified

Aug 2026

Primary completion

Feb 22, 2031

Completion

Feb 22, 2031

Study Design

Enrollment

54 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: several cohorts with the target doses
  Single and multiple dose cohorts. Part 1: Participants will receive different target doses of PF-08154225 in a single and multiple dose escalation stage to evaluate their safety, tolerability, Pharmacokinetic (PK), Pharmacodynamic (PD). Part 2: Participants will receive different doses of PF-08154225 in an open label single arm setting to evaluate their safety, tolerability, PK, PD and preliminary efficacy.

Primary Outcome Measure

Incidence and severity of Treatment Emergent Adverse Event (AE) including protocol specified adverse event of special interest(AESI) [ Time Frame: From first dose through End of Study (up to Week 16 in Part 1a, Week 24 in Part 1b and Week 52 in Part2) ]

Central Contacts

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

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