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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)
Sponsor study identifier
interventional
54
0 countries
N/A
Study Start
November 19, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
February 22, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 22, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 22, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 11, 2026
Actual (reported)August 24, 2026
Actual (reported)November 19, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 22, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 22, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Incidence and severity of Treatment Emergent Adverse Event (AE) including protocol specified adverse event of special interest(AESI)
An AE is defined as any untoward medical event that occurs after a participant receives the investigational drug, which may be manifested as symptoms, signs, diseases, or laboratory abnormalities, but may not necessarily have a causal relationship with the investigational drug.
From first dose through End of Study (up to Week 16 in Part 1a, Week 24 in Part 1b and Week 52 in Part2)
Dose Limiting Toxicity (DLT)
During the DLT observation period (up to 22 days after the last dose)
Frequencies of abnormal safety laboratory tests, vital signs, ECGs.
From first dose of study intervention through End of Study (up to Week 16 in Part 1a, Week 24 in Part 1b and Week 52 in Part 2)
Maximum Observed Serum Concentration (Cmax) of PF-08154225
From first dose through the last pharmacokinetic assessment (up to Week 16 in Part 1a and up to Week 24 in Part 1b)
Time to Maximum Observed Serum Concentration (Tmax) of PF-08154225
From first dose through the last pharmacokinetic assessment (up to Week 16 in Part 1a and up to Week 24 in Part 1b)
Area Under the Serum Concentration-Time Curve (AUC) of PF-08154225
From first dose through the last pharmacokinetic assessment (up to Week 16 in Part 1a and up to Week 24 in Part 1b)
Circulating B-Cell Counts
From first dose of study intervention through End of Study (Week 16 for Part 1a, week 24 for Part 1b and Week 52 for Part 2 or longer if extension of the follow up was needed
Participants With Anti-Drug Antibodies (ADAs) Against PF-08154225
From first dose of study intervention through End of Study (Week 16 for Part 1a, Week 24 for Part 1b and Week 52 for Part2
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.
immune-modulating agent
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Pfizer CT.gov Call Center
Pfizer
First Submitted
August 11, 2026
First Posted
August 24, 2026
Study Start
November 19, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
Contact the study team to confirm eligibility.
February 22, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 22, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 1, 2026
Record last verified: 2026-08
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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