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

A PHASE 2, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE CLINICAL EFFECT, PHARMACODYNAMIC, PHARMACOKINETIC AND SAFETY PROFILE OF PF 06823859 IN ADULT PARTICIPANTS WITH ACTIVE CLE OR SLE WITH CUTANEOUS MANIFESTATIONS

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.

Study Overview

• Status: Terminated
• Conditions: Lupus Erythematosus, Systemic; Lupus Erythematosus, Cutaneous
• Intervention / Treatment: Drug: PF-06823859; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6H 5L5
      • DermEffects
    • Toronto, Ontario, Canada, M4W 2N4
      • Dermatology on Bloor - Research Toronto
    • Whitby, Ontario, Canada, L1P 0p9
      • Whitby Health Centre
• Greece
  • Athens, Greece, 161 21
    • Dermatological and Venereological Hospital Andreas Syggros
  • Attikí
    • Chaïdári, Attikí, Greece, 124 62
      • University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
    • Kaisarianí, Attikí, Greece, 16121
      • Ionos Dragoumi 5 Kaisariani
• Spain
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Seville, Spain, 41013
    • Hospital Universitario Virgen del Rocío
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • The University of Alabama at Birmingham
    • Birmingham, Alabama, United States, 35233
      • The Kirklin Clinic of UAB Hospital
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham - School of Medicine
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham, Department of Dermatology
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Hospital
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic in Arizona - Scottsdale
  • California
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
    • Kansas City, Kansas, United States, 66160
      • The University of Kansas Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group 2; Placebo	Drug: Placebo; Placebo (intravenous infusion)
Experimental: Group 1; PF-06823859	Drug: PF-06823859; PF-06823859 (intravenous infusion)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Type 1 Interferon (IFN) Gene Signature (GS) Score in Lesional Skin at Week 12	Change from baseline GS was calculated as GS(t) - GS(0), where GS(t) was the gene signature score at Week 12 and GS(0) was the gene signature score at Baseline, where the GS(t) was calculated as the mean of log2 transformed counts per million reads from each of 13 genes in RNAseq, the higher GS indicated coordinated higher expression. There is no minimum/maximum limit to the GS score. Gene expression was quantified using RNA sequencing and summarized as log2-transformed counts per million mapped reads [log2(CPM)]. Higher values indicate higher normalized gene expression and without a bounded scale or defined minimum or maximum value.	Baseline, Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) Score at Week 12	CLASI-A measures erythema and scaling or hypertrophy in thirteen skin regions. CLASI-A scores ranges from 0 to 70, with higher scores indicating more severe skin disease.	Baseline, Week 12
Percent Change From Baseline in CLASI-A Score at Weeks 4, 8, 16, 20, 24, 32, 40, 48 and 60	CLASI-A measures erythema and scaling or hypertrophy in thirteen skin regions. CLASI-A scores ranges from 0 to 70, with higher scores indicating more severe skin disease. Participants receiving PF-06823859 continued Q4W then Q8W treatment, while both participants receiving placebo switched to PF-06823859 at Week 16. Results are reported by treatment sequence to reflect protocol pathways and maintained the initial randomized comparison.	Baseline, Weeks 4, 8, 16, 20, 24, 32, 40, 48 and 60
Change From Baseline in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60	CLASI-A measures erythema and scaling or hypertrophy in thirteen skin regions. CLASI-A scores ranges from 0 to 70, with higher scores indicating more severe skin disease. Participants receiving PF-06823859 continued Q4W then Q8W treatment, while both participants receiving placebo switched to PF-06823859 at Week 16. Results are reported by treatment sequence to reflect protocol pathways and maintained the initial randomized comparison.	Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60	CLASI-A measures erythema and scaling or hypertrophy in thirteen skin regions. CLASI-A scores ranges from 0 to 70, with higher scores indicating more severe skin disease. Percentage of participants with >=50 percent reduction in CLASI-A score at the specified timepoints was reported in this outcome measure. Participants receiving PF-06823859 continued Q4W then Q8W treatment, while both participants receiving placebo switched to PF-06823859 at Week 16. Results are reported by treatment sequence to reflect protocol pathways and maintained the initial randomized comparison.	Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Percentage of Participants With >=4 Points Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60	CLASI-A measures erythema and scaling or hypertrophy in thirteen skin regions. CLASI-A scores ranges from 0 to 70, with higher scores indicating more severe skin disease. Percentage of participants with >=4 points reduction in CLASI-A score at the specified timepoints was reported in this outcome measure. Participants receiving PF-06823859 continued Q4W then Q8W treatment, while both participants receiving placebo switched to PF-06823859 at Week 16. Results are reported by treatment sequence to reflect protocol pathways and maintained the initial randomized comparison.	Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Percentage of Participants With >=7 Points Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60	CLASI-A measures erythema and scaling or hypertrophy in thirteen skin regions. CLASI-A scores ranges from 0 to 70, with higher scores indicating more severe skin disease. Percentage of participants with >=7 points reduction in CLASI-A score at the specified timepoints was reported in this outcome measure. Participants receiving PF-06823859 continued Q4W then Q8W treatment, while both participants receiving placebo switched to PF-06823859 at Week 16. Results are reported by treatment sequence to reflect protocol pathways and maintained the initial randomized comparison.	Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Change From Baseline in Physician Global Assessment (PhGA) Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60	PhGA score was assigned by physician as the number within the 0 to 100 millimeter range on visual assessment scale and provided a global characterization of disease. Higher scores indicating more severe disease. Participants receiving PF-06823859 continued Q4W then Q8W treatment, while both participants receiving placebo switched to PF-06823859 at Week 16. Results are reported by treatment sequence to reflect protocol pathways and maintained the initial randomized comparison.	Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60
Number of Participants With Laboratory Test Abnormalities of Grade 3 or More According to Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 5.0	Laboratory test included activated partial thromboplastin time prolonged, alanine aminotransferase increased, alkaline phosphatase increased, anemia, aspartate aminotransferase increased, blood bilirubin increased, creatine phosphokinase (CPK) increased, cholesterol high, creatinine increased, hemoglobin increased, hypercalcemia, hyperkalemia, hypernatremia, hypertriglyceridemia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, international normalized ratio (INR) increased, leukocytosis, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased and white blood cell decreased. Laboratory test abnormalities were graded according to CTCAE v5.0; grade 3=severe, grade 4=life-threatening consequences and grade 5=death. Participants with any laboratory abnormalities of CTCAE v5.0 grade 3 or more were reported in this outcome measure.	For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
Number of Participants With Clinically Significant Vital Signs Abnormalities	Vital signs included systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate (PR). Clinically significant vital signs abnormalities were based on investigator's decision.	For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
Number of Participants With Clinically Significant Electrocardiogram (ECG) Results	ECG parameters included PR interval, QRS duration and QT interval using Fridericia's formula (QTcF) interval. Clinically significant abnormalities in ECG parameters were based on investigator's decision.	For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and Who Discontinued Study Due to TEAEs	An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were the AEs with onset dates on or after the start of the study intervention up to after last dose of study intervention. An serious adverse event (SAE) was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or any other pre-specified criteria in protocol of the study or other important medical events. AEs included SAEs (if occurred) and all other AEs (including non-SAEs).	For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2023
• Primary Completion (Actual): June 5, 2025
• Study Completion (Actual): November 18, 2025

Study Registration Dates

• First Submitted: May 18, 2023
• First Submitted That Met QC Criteria: May 18, 2023
• First Posted (Actual): May 30, 2023

Study Record Updates

• Last Update Posted (Actual): August 11, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: type 1 IFN gene signature, SLE, CLE
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic; Lupus Erythematosus, Cutaneous
• Other Study ID Numbers: C0251013; 2023-503343-33-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No