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Lupus skin drug trial halted early – only 8 volunteers joined
NCT ID NCT05879718
First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 2 times
Summary
This study tested an experimental drug called PF-06823859 for adults with lupus that affects the skin. The goal was to see if the drug could reduce skin inflammation and improve symptoms. The trial was stopped early and only enrolled 8 people instead of the planned 48, so results are very limited.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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8 people
The number who actually took part.
- Started
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Jul 2023
- Finished
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Nov 2025
- 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 75 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.
Inclusion Criteria: * Have a histologically confirmed active CLE or SLE with cutaneous manifestations in the form of subacute cutaneous lupus erythematosus or/and discoid/chronic cutaneous lupus erythematosus at least 3 months and CLASI-A at least 8 or higher. * Participant has adequate intravenous infusion access per investigator's judgement * Willing to comply with study procedures including skin punch biopsies procedures. * Weight is greater than 40 kg and less than 130 kg. Exclusion Criteria: * Skin disorders other than CLE or SLE. * Active, severe lupus nephritis requiring treatment with cytotoxic agents or high-dose steroids. * Active severe central nervous system lupus requiring therapeutic intervention within 60 days of baseline. * Cancer or a history of cancer within 5 years of screening except adequately resected basal or squamous cell carcinoma of the skin, or carcinoma in situ of uterine cervix. * Known history of a major cardiovascular or cerebrovascular event within 24 months, pulmonary arterial hypertension, pulmonary embolism within 6 months of screening. * Have any autoimmune or inflammatory disease that would interfere with interpretation of test results or clinical assessments. * History of disseminated herpes zoster/simplex or recurrent herpes zoster. * Serious infection within 60 days of baseline or an active infection treated with oral antibiotics within 14 days of baseline. * Have evidence of active or latent infection of hepatitis B or C, known history of human immunodeficient virus (HIV) infection, or infected with Mycobacterium TB (active or latent TB) * Laboratory abnormalities that meet exclusion criteria at the Screening visit. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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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.
Contacts and locations
Locations
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Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
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DermEffects
London, Ontario, N6H 5L5, Canada
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Dermatological and Venereological Hospital Andreas Syggros
Athens, 161 21, Greece
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Dermatology Research Associates
Los Angeles, California, 90045, United States
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Dermatology on Bloor - Research Toronto
Toronto, Ontario, M4W 2N4, Canada
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Emory University
Atlanta, Georgia, 30322, United States
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Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
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Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
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Ionos Dragoumi 5 Kaisariani
Kaisarianí, Attikí, 16121, Greece
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Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
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Mayo Clinic in Arizona - Scottsdale
Scottsdale, Arizona, 85259, United States
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The Kirklin Clinic of UAB Hospital
Birmingham, Alabama, 35233, United States
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The University of Alabama at Birmingham
Birmingham, Alabama, 35249, United States
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The University of Kansas Hospital
Kansas City, Kansas, 66160, United States
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University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
Chaïdári, Attikí, 124 62, Greece
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University of Alabama at Birmingham - School of Medicine
Birmingham, Alabama, 35233, United States
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University of Alabama at Birmingham, Department of Dermatology
Birmingham, Alabama, 35233, United States
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University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
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Whitby Health Centre
Whitby, Ontario, L1P 0p9, Canada
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