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Systemic Lupus ErythematosusPhase 1/2NCT07782450

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

A Phase 1/2 study testing PF-08154225 in people with Systemic Lupus Erythematosus and Rheumatoid Arthritis, run by Pfizer.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
PF-08154225
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
No sites listed yet
Study dates
19 Nov 2026to 22 Feb 2031
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

About this study

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)

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).

Read more

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.

Read the detailed description

This clinical trial consists of Part I and Part II. Phase I consists of dose escalation. The main goal of dose escalation is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-08154225 in participants with Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA), and the main goal of Part II is to assess effects of PF-08154225 on the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy in participants with SLE or RA or IIM or SSc.

Being tested
PF-08154225
Medical subject headings
Lupus Erythematosus, Systemic, Arthritis, Rheumatoid, Myositis, Scleroderma, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-08154225Drug

    immune-modulating agent

Study groups in NCT07782450
Study groupRoleWhat they receive
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.
Receives: Drug: PF-08154225

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From first dose through End of Study (up to Week 16 in Part 1a, Week 24 in Part 1b and Week 52 in Part2)

  2. Dose Limiting Toxicity (DLT)

    Measured: During the DLT observation period (up to 22 days after the last dose)

  3. Frequencies of abnormal safety laboratory tests, vital signs, ECGs.

    Measured: 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 outcomes (22)

  1. Maximum Observed Serum Concentration (Cmax) of PF-08154225

    Measured: From first dose through the last pharmacokinetic assessment (up to Week 16 in Part 1a and up to Week 24 in Part 1b)

  2. Time to Maximum Observed Serum Concentration (Tmax) of PF-08154225

    Measured: From first dose through the last pharmacokinetic assessment (up to Week 16 in Part 1a and up to Week 24 in Part 1b)

  3. Area Under the Serum Concentration-Time Curve (AUC) of PF-08154225

    AUClast, AUCinf, and AUCtau will be assessed as data permit.

    Measured: From first dose through the last pharmacokinetic assessment (up to Week 16 in Part 1a and up to Week 24 in Part 1b)

  4. Circulating B-Cell Counts

    Measured: 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

  5. Participants With Anti-Drug Antibodies (ADAs) Against PF-08154225

    Measured: 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

  6. Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score

    Measured: Baseline, Week 52

  7. Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Score

    Measured: Baseline, Week 52

  8. Change From Baseline in Tender Joint Count

    Measured: Baseline, Week 52

  9. Change From Baseline in Swollen Joint Count

    Measured: Baseline, Week 52

  10. Change From Baseline in Physician Global Assessment Score

    Measured: Baseline, Week 52

  11. Number of Participants With DORIS Remission

    Measured: Up to Week 52

  12. Number of Participants With Lupus Low Disease Activity State (LLDAS)

    Measured: Up to Week 52

  13. Number of Participants With SLE Responder Index-4 (SRI-4) Response

    Measured: Up to Week 52

  14. Number of Participants With Disease Flare

    Measured: Up to Week 52

  15. Change From Baseline in Disease Activity Score 28 Using C-Reactive Protein (DAS28-CRP)

    Measured: Baseline, Week 52

  16. Change From Baseline in Simplified Disease Activity Index (SDAI)

    Measured: Baseline, Week 52

  17. Participants Achieving American College of Rheumatology (ACR) Response Criteria

    Measured: Up to Week 52

  18. Change From Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Score

    Measured: Baseline, Week 52

  19. Change From Baseline in Manual Muscle Testing-8 (MMT-8) Score

    Measured: Baseline, Week 52

  20. Change From Baseline in International Myositis Assessment and Clinical Studies Total Improvement Score (IMACS TIS)

    Measured: Baseline, Week 52

  21. Change From Baseline in Modified Rodnan Skin Score (mRSS) in Participants With Systemic Sclerosis

    Measured: Baseline, Week 52

  22. Participants Achieving Composite Response Index in Systemic Sclerosis (CRISS) Response

    Measured: Up to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2026
  2. Study start19 Nov 2026 (estimated)
  3. Primary completion22 Feb 2031 (estimated)
  4. Study completion22 Feb 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
open label, single arm, sequential dose escalation cohorts
Masking
None (open label)
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07782450
Sponsor's protocol ID
C6441001
Status last verified
Aug 2026
First submitted
11 Aug 2026
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PF-08154225 in people with Systemic Lupus Erythematosus and Rheumatoid Arthritis, run by Pfizer.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of Treatment Emergent Adverse Event (AE) including protocol specified adverse event of special interest(AESI) (time frame: From first dose through End of Study (up to Week 16 in Part 1a, Week 24 in Part 1b and Week 52 in Part2)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07782450.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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