A Study to Learn About the Study Medicine (PF-06823859) in Adults With Active CLE or SLE With Skin Symptoms.
NCT ID: NCT05879718
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
8 participants
INTERVENTIONAL
2023-07-07
2025-11-18
Brief Summary
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This study is seeking for participants who:
* are adults of 18 years of age or older.
* are confirmed to have CLE or SLE with involvement of the skin.
* have a Cutaneous Lupus Erythematosus Disease Area and Severity Index activity (CLASI-A) score of at least 8.
About 48 participants will be selected to receive active study medicine (PF-06823859) or placebo (an infusion without drug). About 32 are grouped to receive the active study medicine and 16 are to receive placebo. They will be receiving the treatments by intravenous infusion (injected directly into the veins).
At week 16 all participants receiving the active study drug since day 1 and participants who have received placebo since day 1 and are not responding clinically will receive active study medication. Patients who have received placebo since Day 1 and who have had a clinical response will continue to receive placebo till week 40. All participants will have last follow-up visit at Week 60.
The study will compare participants receiving PF-06823859 to participants who receive placebo. This will help us see if PF-06823859 is safe and effective to treat CLE or SLE with skin symptoms and improve participant's CLASI-A score. Participants will take part in this study for about 65 weeks. This includes up to a 5-week selection period, a 12-week Q4Wk treatment period, a 36-week Q8Wk treatment period, and a 12-week follow-up period.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group 1
PF-06823859
PF-06823859
PF-06823859 (intravenous infusion)
Group 2
Placebo
Placebo
Placebo (intravenous infusion)
Interventions
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PF-06823859
PF-06823859 (intravenous infusion)
Placebo
Placebo (intravenous infusion)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
75 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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The Kirklin Clinic of UAB Hospital
Birmingham, Alabama, United States
University of Alabama at Birmingham - School of Medicine
Birmingham, Alabama, United States
University of Alabama at Birmingham, Department of Dermatology
Birmingham, Alabama, United States
The University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic Hospital
Phoenix, Arizona, United States
Mayo Clinic in Arizona - Scottsdale
Scottsdale, Arizona, United States
Dermatology Research Associates
Los Angeles, California, United States
Emory University
Atlanta, Georgia, United States
The University of Kansas Hospital
Kansas City, Kansas, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
DermEffects
London, Ontario, Canada
Dermatology on Bloor - Research Toronto
Toronto, Ontario, Canada
Whitby Health Centre
Whitby, Ontario, Canada
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
Chaïdári, Attikí, Greece
Ionos Dragoumi 5 Kaisariani
Kaisarianí, Attikí, Greece
Dermatological and Venereological Hospital Andreas Syggros
Athens, , Greece
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2023-503343-33-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
C0251013
Identifier Type: -
Identifier Source: org_study_id
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