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

NCT ID
NCT07782450
Registry status
Not yet recruiting
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Pfizer
Conditions
Idiopathic Inflammatory Myositis, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Systemic Sclerosis

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

Official title: A PHASE 1/2, MULTI-CENTER, OPEN-LABEL, SINGLE- AND MULTIPLE-DOSEESCALATION, DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND PRELIMINARY EFFICACY OF PF-08154225, IN PARTICIPANTS WITH AUTOIMMUNE DISEASES INCLUDING ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE), OR RHEUMATOID ARTHRITIS (RA), OR IDIOPATHIC INFLAMMATORY MYOSITIS (IIM) OR SYSTEMIC SCLEROSIS (SSC)

Enrollment: 54 participants (Estimated).

What is being studied

No interventions are listed in the registry data.

Who may be eligible

Ages
18 Years to 70 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Select Inclusion Criteria 1. At age between 18 and 70 years at Screening. 2. Confirmed diagnosis of RA according to the 2010 American College of Rheumatology (ACR)/ European Alliance of Associations for Rheumatology (EULAR) criteria at Screening, with symptom at least 6 months prior to Screening 3. Clinical diagnosis of SLE according to the 1997 ACR Criteria for the Classification of SLE Or confirmed diagnosis of SLE according to the Systemic Lupus International Collaborating Clinics (SLICC) Classification Criteria at Screening, with symptom at least 6 months prior to Screening. 4. Clinical diagnosis of 1 of the 3 IIM subtypes based on phenotype, and/or prior muscle biopsy, and positive myositis-specific autoantibody (MSA) / myositis-associated antibody (MMA) 5. Classification of SSc according to the 2013 ACR/EULAR criteria at Screening Select Exclusion Criteria 1. Any medical or psychiatric condition, including active suicidal ideation or any laboratory abnormality, that increases study risk or makes the participant unsuitable. 2. Active central nervous system (CNS) co-morbidity 3. Any complications of disease under study that in the judgement of the investigator may be life or organ threatening or require prohibited medication 4. Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection 5. Active or recent clinically significant infections 6. Chronic or active Hepatitis B and C 7. Past or current therapies with T-cell engager (TCEs), bone marrow cell transplant, stem cell transplant, chimeric antigen receptor T-cell (CAR-T) cell therapy. 8. For SLE, no catastrophic or severe antiphospholipid syndrome (APS), severe unstable neuropsychiatric SLE. 9. Felty's syndrome, juvenile arthritis or idiopathic arthritis before age of 16 10. SSc renal crisis within 6 months prior to screening, UIP pattern if entering on interstitial lung disease interstitial lung disease (ILD) criteria 11. Diagnosis of Inclusion body myositis (IBM) and Usual interstitial pneumonia (UIP) pattern if entering on ILD criteria

Study locations

No study locations are listed in the registry data.

Study details

Start date
November 19, 2026
Primary completion date
February 22, 2031
Completion date
February 22, 2031
First posted
August 24, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07782450
Registry last updated
October 1, 2026
QualifiedStudies registry data refreshed
October 5, 2026
QualifiedStudies record fetched
October 5, 2026

View NCT07782450 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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