Can a single drug tame multiple autoimmune diseases?
NCT ID NCT07782450
First seen Aug 24, 2026 · Last updated Aug 28, 2026 · Updated 2 times
Summary
This trial tests an experimental drug called PF-08154225 in people with autoimmune diseases like lupus, rheumatoid arthritis, myositis, or scleroderma. The drug aims to calm the immune system, which mistakenly attacks healthy cells in these conditions. Participants receive the drug in different doses and schedules to check its safety and how well it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PF-08154225, an immune-modulating agent
- What this could lead to
- If successful, this could lead to a new treatment option that helps control autoimmune diseases like lupus and rheumatoid arthritis by calming the overactive immune system.
- What could go wrong
- This is an early-phase trial with a small number of participants, so safety and effectiveness are not yet proven. The drug may cause side effects or may not work as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 54 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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