A Study to Learn About the Study Medicine (PF-06823859) in Adults With Active CLE or SLE With Skin Symptoms.

Last updated: April 9, 2025
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

2

Condition

Cutaneous Lupus Erythematosus

Systemic Lupus Erythematosus

Lupus

Treatment

Placebo

PF-06823859

Clinical Study ID

NCT05879718
C0251013
2023-503343-33-00
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to learn about the effects, safety and how PF-06823859 is processed in adults with cutaneous lupus erythematosus (CLE) or systemic lupus erythematosus (SLE) showing some skin symptoms.

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a histologically confirmed active CLE or SLE with cutaneous manifestations inthe form of subacute cutaneous lupus erythematosus or/and discoid/chronic cutaneouslupus 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

Exclusion Criteria:

  • Skin disorders other than CLE or SLE.

  • Active, severe lupus nephritis requiring treatment with cytotoxic agents orhigh-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 resectedbasal or squamous cell carcinoma of the skin, or carcinoma in situ of uterinecervix.

  • 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 interpretationof 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 withoral antibiotics within 14 days of baseline.

  • Have evidence of active or latent infection of hepatitis B or C, known history ofhuman immunodeficient virus (HIV) infection, or infected with Mycobacterium TB (active or latent TB)

  • Laboratory abnormalities that meet exclusion criteria at the Screening visit. Theabove information is not intended to contain all considerations relevant to apatient's potential participation in a clinical trial.

Study Design

Total Participants: 48
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
July 07, 2023
Estimated Completion Date:
November 18, 2026

Connect with a study center

  • Alberta Dermasurgery Centre

    Edmonton, Alberta T6G 1C3
    Canada

    Active - Recruiting

  • DermEffects

    London, Ontario N6H 5L5
    Canada

    Active - Recruiting

  • Oshawa Clinic Dermatology Trials

    Oshawa, Ontario L1H 1B9
    Canada

    Site Not Available

  • Dermatology on Bloor - Research Toronto

    Toronto, Ontario M4W 2N4
    Canada

    Active - Recruiting

  • Oshawa Clinic Dermatology Trials

    Whitby, Ontario L1P 1Y5
    Canada

    Active - Recruiting

  • Alpha Recherche Clinique

    Quebec, G2J 0C4
    Canada

    Site Not Available

  • Attikon General University Hospital

    Chaidari, Attikí 124 62
    Greece

    Active - Recruiting

  • Ionos Dragoumi 5 Kaisariani

    Kaisariani, Attikí 16121
    Greece

    Active - Recruiting

  • Dermatological and Venereological Hospital Andreas Syggros

    Athens, 161 21
    Greece

    Active - Recruiting

  • CHUAC-Complejo Hospitalario Universitario A Coruña

    A Coruña, A Coruña [LA Coruña] 15006
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [barcelona] 08035
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Del Rocio

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan City, Taoyuan 333
    Taiwan

    Active - Recruiting

  • Taichung Veterans General Hospital

    Taichung, 407
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Active - Recruiting

  • The Kirklin Clinic of UAB Hospital

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • The University of Alabama at Birmingham

    Birmingham, Alabama 35249
    United States

    Active - Recruiting

  • University of Alabama at Birmingham - School of Medicine

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • University of Alabama at Birmingham, Department of Dermatology

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • Mayo Clinic Hospital

    Phoenix, Arizona 85054
    United States

    Active - Recruiting

  • Mayo Clinic in Arizona - Scottsdale

    Scottsdale, Arizona 85259
    United States

    Active - Recruiting

  • Perlman Clinic

    La Jolla, California 92037
    United States

    Active - Recruiting

  • UCSD - Altman Clinical and Translational Research Institute (ACTRI)

    La Jolla, California 92037
    United States

    Active - Recruiting

  • University of California, San Diego - Altman Clinical and Translational Research Institute (Infusion

    La Jolla, California 92037
    United States

    Active - Recruiting

  • University of California, San Diego - Altman Clinical and Translational Research Institute (Investig

    La Jolla, California 92037
    United States

    Active - Recruiting

  • Dermatology Research Associates

    Los Angeles, California 90045
    United States

    Active - Recruiting

  • Mayo Clinic in Florida

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • Emory University

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Advanced Medical Research, PC.

    Sandy Springs, Georgia 30328
    United States

    Active - Recruiting

  • The University of Kansas Hospital

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Barnes-Jewish Hospital

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Barnes-Jewish Hospital Investigational Drug Service

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Center for Advanced Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Center for Outpatient Health

    Saint Louis, Missouri 63108
    United States

    Active - Recruiting

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

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