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

NCT05879718 | Terminated Phase 2 DMC FDA Drug

• 2 other identifiers: C02510132023-503343-33-00
• Study Type: interventional
• Target: 8
• Locations: 4 countries
• Sites: 19

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.

Conditions

Lupus Erythematosus, Systemic; Lupus Erythematosus, Cutaneous

Keywords

type 1 IFN gene signature, SLE, CLE

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Percent change from baseline in CLASI-A score at Week 12

  Week 12

• 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

• Change from baseline in CLASI-A score (over time)

  Week 4, 8, 12, 16, 20, 24, 32, 40, 48, and 60

• Achieving ≥50%, 4 or 7 points reduction in CLASI-A (over time)

  Week 4, 8, 12, 16, 20, 24, 32, 40, 48, and 60

• Change from baseline in Physician global assessment (PhGA) (over time)

  Week 4, 8, 12, 16, 20, 24, 32, 40, 48, and 60

Study Arms (2)

Group 1

EXPERIMENTAL

PF-06823859

Drug: PF-06823859

Group 2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Placebo DRUG

Placebo (intravenous infusion)

Group 2

PF-06823859 DRUG

PF-06823859 (intravenous infusion)

Group 1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pfizer: lead

Study Sites (19)

The Kirklin Clinic of UAB Hospital

Birmingham, Alabama, 35233, United States

Location

University of Alabama at Birmingham - School of Medicine

Birmingham, Alabama, 35233, United States

Location

University of Alabama at Birmingham, Department of Dermatology

Birmingham, Alabama, 35233, United States

Location

The University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

Mayo Clinic Hospital

Phoenix, Arizona, 85054, United States

Location

Mayo Clinic in Arizona - Scottsdale

Scottsdale, Arizona, 85259, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

The University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

DermEffects

London, Ontario, N6H 5L5, Canada

Location

Dermatology on Bloor - Research Toronto

Toronto, Ontario, M4W 2N4, Canada

Location

Whitby Health Centre

Whitby, Ontario, L1P 0p9, Canada

Location

University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"

Chaïdári, Attikí, 124 62, Greece

Location

Ionos Dragoumi 5 Kaisariani

Kaisarianí, Attikí, 16121, Greece

Location

Dermatological and Venereological Hospital Andreas Syggros

Athens, 161 21, Greece

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain

Location

Related Links

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

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Lupus Erythematosus, Cutaneous

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: About 48 eligible participants will be randomized in a 2:1 ratio to receive either PF-06823859 or placebo. Following assessments for the primary endpoint at Week 12, participants who are receiving active PF-06823859 or who are placebo non responders (responder is defined by ≥4 point reduction from the baseline in CLASI-A score) will receive PF-06823859 beginning at Week 16, while placebo responders will continue to be in the placebo group. The last dose of study intervention will be administered at Week 40 followed by last full study assessments at Week 48. The final follow up visit will be conducted at Week 60.

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: May 30, 2023
• Study Start: July 7, 2023
• Primary Completion: June 5, 2025
• Study Completion: November 18, 2025
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

CA (3); US (11); ES (2); GR (3)