A Study to Learn About a Medicine Called PF-08154225 in Participants With Autoimmune Diseases
NCT07782450 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 54
Last updated 2026-08-24
Summary
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.
Conditions
- Systemic Lupus Erythematosus
- Rheumatoid Arthritis
- Idiopathic Inflammatory Myositis
- Systemic Sclerosis
Interventions
- DRUG
-
PF-08154225
immune-modulating agent
Sponsors & Collaborators
-
Syneos
collaborator UNKNOWN - lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-16
- Primary Completion
- 2031-02-22
- Completion
- 2031-02-22
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