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

StatusNot Yet Recruiting
PhasePhase 1/2
SponsorPfizer
Started

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Record History

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  1. Notable Start date pushed from Oct 10, 2026 to Nov 19, 2026
    • Eligibility criteria expanded, about 16 words
  2. Notable Start date: Sep 10, 2026 to Oct 10, 2026v3
  3. Minor Start date: Aug 16, 2026 to Sep 10, 2026v2
  4. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
438 trials monitored
See 32 trials at risk
667 trials monitored
See 27 trials at risk
324 trials monitored
See 14 trials at risk
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.
Trial Details
NCT Number NCT07782450
Lead Sponsor Pfizer
Collaborators: Syneos
Conditions
(from sponsor)
Systemic Lupus Erythematosus, Rheumatoid Arthritis, Idiopathic Inflammatory Myositis, Systemic Sclerosis
Related terms Arthritis, Rheumatoid, Lupus Erythematosus, Systemic, Myositis, Scleroderma, Systemic
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov