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

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Canada
  • Quebec, Canada, G2J 0C4
    • Recruiting
    • ALPHA Recherche Clinique
  • Ontario
    • London, Ontario, Canada, N6H 5L5
      • Recruiting
      • Dermeffects
    • Oshawa, Ontario, Canada, L1H 1B9
      • Recruiting
      • Oshawa Clinic Dermatology Trials
    • Toronto, Ontario, Canada, M4W 2N4
      • Recruiting
      • Dermatology on Bloor - Research Toronto
• Greece
  • Athens, Greece, 161 21
    • Recruiting
    • Dermatological and Venereological Hospital Andreas Syggros
  • Attikí
    • Chaidari, Attikí, Greece, 124 62
      • Recruiting
      • Attikon General University Hospital
    • Kaisariani, Attikí, Greece, 16121
      • Recruiting
      • Ionos Dragoumi 5 Kaisariani
• Spain
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 De Octubre
  • Sevilla, Spain, 41013
    • Recruiting
    • Hospital Universitario Virgen del Rocío
  • A Coruña [LA Coruña]
    • A Coruña, A Coruña [LA Coruña], Spain, 15006
      • Not yet recruiting
      • CHUAC-Complejo Hospitalario Universitario A Coruña
  • Barcelona [barcelona]
    • Barcelona, Barcelona [barcelona], Spain, 08035
      • Recruiting
      • Hospital Universitari Vall d'Hebron
• Taiwan
  • Taichung, Taiwan, 407
    • Recruiting
    • Taichung Veterans General Hospital
  • Taipei, Taiwan, 11217
    • Recruiting
    • Taipei Veterans General Hospital
  • Taoyuan
    • Taoyuan City, Taoyuan, Taiwan, 333
      • Recruiting
      • Chang Gung Medical Foundation-Linkou Branch
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Recruiting
      • Mayo Clinic Hospital
    • Scottsdale, Arizona, United States, 85259
      • Recruiting
      • Mayo Clinic in Arizona - Scottsdale
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • The University of Kansas Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Not yet recruiting
      • Washington University School of Medicine
    • Saint Louis, Missouri, United States, 63110
      • Not yet recruiting
      • Barnes-Jewish Hospital
    • Saint Louis, Missouri, United States, 63108
      • Not yet recruiting
      • Center for Outpatient Health
    • Saint Louis, Missouri, United States, 63110
      • Not yet recruiting
      • Center for Advanced Medicine
    • Saint Louis, Missouri, United States, 63110
      • Not yet recruiting
      • Barnes-Jewish Hospital Investigational Drug Service
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • 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 IFN GS score in lesional skin at 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.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change from baseline in CLASI-A score at Week 12	The Cutaneous Lupus Erythematosus Disease Activity and Damage Score	Week 12
Percent change from baseline in CLASI-A (over time in addition to Week 12)	Percent Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score	Week 4, 8, 12, 16, 20, 24, 32, 40, 48, and 60
Change from baseline in CLASI-A score (over time)	Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score	Week 4, 8, 12, 16, 20, 24, 32, 40, 48, and 60
Achieving ≥50%, 4 or 7 points reduction in CLASI-A (over time)	Achieving ≥50%, 4 or 7 points reduction in CLASI-A	Week 4, 8, 12, 16, 20, 24, 32, 40, 48, and 60
Change from baseline in Physician global assessment (PhGA) (over time)	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).	Week 4, 8, 12, 16, 20, 24, 32, 40, 48, and 60
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

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 (Estimated): December 17, 2025
• Study Completion (Estimated): November 18, 2026

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): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: type 1 IFN gene signature, SLE, CLE
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Autoimmune Diseases; 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