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

Lupus Erythematosus, Systemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05879718
• Other study ID #: C0251013
• Secondary ID: 2023-503343-33-0
• Status: Recruiting
• Phase: Phase 2
• Start date: July 7, 2023
• Est. completion date: November 18, 2026

Study information

• Verified date: May 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: November 18, 2026
• Est. primary completion date: December 17, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Cutaneous
• Lupus Erythematosus, Systemic

Intervention

Drug:
• Placebo
Placebo (intravenous infusion)
• PF-06823859
PF-06823859 (intravenous infusion)

Locations

Country	Name	City	State
Canada	DermEffects	London	Ontario
Canada	Oshawa Clinic Dermatology Trials	Oshawa	Ontario
Canada	Alpha Recherche Clinique	Quebec
Canada	Dermatology on Bloor - Research Toronto	Toronto	Ontario
Greece	Dermatological and Venereological Hospital Andreas Syggros	Athens
Greece	Attikon General University Hospital	Chaidari	Attikí
Greece	Ionos Dragoumi 5 Kaisariani	Kaisariani	Attikí
Spain	CHUAC-Complejo Hospitalario Universitario A Coruña	A Coruña	A Coruña [LA Coruña]
Spain	Hospital Universitari Vall d'Hebron	Barcelona	Barcelona [barcelona]
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Virgen Del Rocio	Sevilla
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Chang Gung Medical Foundation-Linkou Branch	Taoyuan City	Taoyuan
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	The University of Kansas Hospital	Kansas City	Kansas
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Mayo Clinic Hospital	Phoenix	Arizona
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	Barnes-Jewish Hospital Investigational Drug Service	Saint Louis	Missouri
United States	Center for Advanced Medicine	Saint Louis	Missouri
United States	Center for Outpatient Health	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Mayo Clinic in Arizona - Scottsdale	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Greece,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percent change from baseline in CLASI-A score at Week 12	The Cutaneous Lupus Erythematosus Disease Activity and Damage Score	Week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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