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PF-08154225

Phase 1

Systemic Lupus Erythematosus | Small molecule | Immunology |Pfizer, Inc.|Last Updated: Aug 28, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

Clinical trial landscape

PF-08154225 · 1 trial · 4 indications

Phase 1 1
NCT07782450A Study to Learn About a Medicine Called PF-08154225 in Participants With Autoimmune DiseasesSystemic Lupus Erythematosus
NOT YET_RECRUITING54 Analytics
PHASE1NOT YET_RECRUITING
A Study to Learn About a Medicine Called PF-08154225 in Participants With Autoimmune Diseases
Systemic Lupus ErythematosusUnlock trial analytics

Study Endpoints

Primary Endpoints

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

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.

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)

Secondary Endpoints

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)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
several cohorts with the target dosesEXPERIMENTALSingle 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.

Interventions

NameTypeDescription
PF-08154225DRUGimmune-modulating agent
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo

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....

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Recent Changes (Last 90 Days)

LOWAug 28, 2026NCT07782450startDate: changed
LOWAug 28, 2026NCT07782450startDate: changed
LOWAug 24, 2026NCT07782450NEW_TRIAL: changed
LOWAug 24, 2026NCT07782450NEW_TRIAL: changed

Frequently asked questions about PF-08154225

What is PF-08154225 used for?

PF-08154225 is an investigational small molecule being developed for the treatment of Systemic Lupus Erythematosus (SLE). It is also being studied in other autoimmune diseases including Rheumatoid Arthritis, Idiopathic Inflammatory Myositis, and Systemic Sclerosis. The drug is currently in Phase 1 clinical development.

Who makes PF-08154225?

PF-08154225 is being developed by Pfizer, Inc. (NYSE: PFE). The company is currently conducting a Phase 1 clinical trial to evaluate the drug in participants with autoimmune diseases.

What phase is PF-08154225 in?

PF-08154225 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 study is designed to evaluate the drug in participants with autoimmune diseases.

What clinical trials is PF-08154225 in?

PF-08154225 is being studied in a Phase 1 clinical trial registered as NCT07782450, titled "A Study to Learn About a Medicine Called PF-08154225 in Participants With Autoimmune Diseases." The trial is not yet recruiting and has an estimated enrollment of 54 participants.

What is the trial for PF-08154225 studying?

The Phase 1 trial for PF-08154225 (NCT07782450) is studying the drug in participants with Systemic Lupus Erythematosus, Rheumatoid Arthritis, Idiopathic Inflammatory Myositis, and Systemic Sclerosis. The trial is open to adults aged 18 years and older and is not yet recruiting participants.