A Study to Learn About the Study Medicine (PF-06823859) in Adults With Active CLE or SLE With Skin Symptoms.
- Conditions
- Lupus Erythematosus, SystemicLupus Erythematosus, Cutaneous
- Interventions
- Drug: Placebo
- Registration Number
- NCT05879718
- Lead Sponsor
- Pfizer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 48
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 PF-06823859 PF-06823859 Group 2 Placebo Placebo
- Primary Outcome Measures
Name Time Method Change from baseline in type 1 IFN GS score in lesional skin at Week 12 Week 12 A 13-gene IFN gene signature score was used to measure IFN activity at both baseline and week 12, the gene signature score is assessed per sample by averaging the log2CPM(Counts Per Million reads) values of these 13 genes through RNAseq profiling. The gene signature score is positively linked to the gene expression activity of those 13 genes that are related to IFN.
- Secondary Outcome Measures
Name Time Method Change from baseline in CLASI-A score (over time) Week 4, 8, 12, 16, 20, 24, 32, 40, 48, and 60 Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score
Achieving ≥50%, 4 or 7 points reduction in CLASI-A (over time) Week 4, 8, 12, 16, 20, 24, 32, 40, 48, and 60 Achieving ≥50%, 4 or 7 points reduction in CLASI-A
Incidence and severity of laboratory, vital signs, 12-lead ECG abnormalities, AEs, SAEs and withdrawals due to AEs over time Day 1, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 56, and 60 Change from baseline in Physician global assessment (PhGA) (over time) Week 4, 8, 12, 16, 20, 24, 32, 40, 48, and 60 The PhGA is a visual analog scale (VAS) tool to measure worsening in the participant general health status. Physician will place a mark on the scale between 0 (none), 1 (mild), 2(moderate) and 3 (severe).
Percent change from baseline in CLASI-A score at Week 12 Week 12 The Cutaneous Lupus Erythematosus Disease Activity and Damage Score
Percent change from baseline in CLASI-A (over time in addition to Week 12) Week 4, 8, 12, 16, 20, 24, 32, 40, 48, and 60 Percent Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score
Trial Locations
- Locations (36)
Alberta Dermasurgery Centre
🇨🇦Edmonton, Alberta, Canada
Perlman Clinic
🇺🇸La Jolla, California, United States
UCSD - Altman Clinical and Translational Research Institute (ACTRI)
🇺🇸La Jolla, California, United States
University of California, San Diego - Altman Clinical and Translational Research Institute (Infusion
🇺🇸La Jolla, California, United States
University of California, San Diego - Altman Clinical and Translational Research Institute (Investig
🇺🇸La Jolla, California, United States
Hospital Universitario Virgen Del Rocio
🇪🇸Sevilla, Spain
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
Mayo Clinic in Florida
🇺🇸Jacksonville, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Advanced Medical Research, PC.
🇺🇸Sandy Springs, Georgia, United States
The University of Kansas Hospital
🇺🇸Kansas City, Kansas, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Center for Outpatient Health
🇺🇸Saint Louis, Missouri, United States
Barnes-Jewish Hospital Investigational Drug Service
🇺🇸Saint Louis, Missouri, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Center for Advanced Medicine
🇺🇸Saint Louis, Missouri, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
DermEffects
🇨🇦London, Ontario, Canada
Dermatology on Bloor - Research Toronto
🇨🇦Toronto, Ontario, Canada
Oshawa Clinic Dermatology Trials
🇨🇦Whitby, Ontario, Canada
Attikon General University Hospital
🇬🇷Chaidari, Attikí, Greece
Ionos Dragoumi 5 Kaisariani
🇬🇷Kaisariani, Attikí, Greece
Dermatological and Venereological Hospital Andreas Syggros
🇬🇷Athens, Greece
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Barcelona [barcelona], Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Chang Gung Medical Foundation-Linkou Branch
🇨🇳Taoyuan City, Taoyuan, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan