Clinical trial NCT05879718: A Study to Learn About the Study Medicine (PF-06823859) in Adults With Active CLE or SLE With Skin Symptoms.
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Lupus Erythematosus, Systemic
Lupus Erythematosus, Cutaneous
Keywords: type 1 IFN gene signature, SLE, CLE
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-05-30
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in type 1 IFN GS score in lesional skin at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Percent change from baseline in CLASI-A score at Week 12
timeFrame: Week 12
measure: Percent change from baseline in CLASI-A (over time in addition to Week 12)
timeFrame: Week 4, 8, 12, 16, 20, 24, 32, 40, 48, and 60
measure: Change from baseline in CLASI-A score (over time)
timeFrame: Week 4, 8, 12, 16, 20, 24, 32, 40, 48, and 60
measure: Achieving ≥50%, 4 or 7 points reduction in CLASI-A (over time)
timeFrame: Week 4, 8, 12, 16, 20, 24, 32, 40, 48, and 60
measure: Change from baseline in Physician global assessment (PhGA) (over time)
timeFrame: Week 4, 8, 12, 16, 20, 24, 32, 40, 48, and 60
measure: Incidence and severity of laboratory, vital signs, 12-lead ECG abnormalities, AEs, SAEs and withdrawals due to AEs over time
timeFrame: Day 1, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 56, and 60
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The Kirklin Clinic of UAB Hospital
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham - School of Medicine
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham, Department of Dermatology
state: Alabama
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Mayo Clinic Hospital
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona - Scottsdale
state: Arizona
city: La Jolla
country: United States
facility: Perlman Clinic
state: California
city: La Jolla
country: United States
facility: UCSD - Altman Clinical and Translational Research Institute (ACTRI)
state: California
city: La Jolla
country: United States
facility: University of California, San Diego - Altman Clinical and Translational Research Institute (Infusion
state: California
city: La Jolla
country: United States
facility: University of California, San Diego - Altman Clinical and Translational Research Institute (Investig
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Sandy Springs
country: United States
facility: Advanced Medical Research, PC.
state: Georgia
city: Kansas City
country: United States
facility: The University of Kansas Hospital
state: Kansas
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: Center for Outpatient Health
state: Missouri
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital Investigational Drug Service
state: Missouri
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Center for Advanced Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Edmonton
country: Canada
facility: Alberta Dermasurgery Centre
state: Alberta
city: London
country: Canada
facility: DermEffects
state: Ontario
city: Toronto
country: Canada
facility: Dermatology on Bloor - Research Toronto
state: Ontario
city: Whitby
country: Canada
facility: Oshawa Clinic Dermatology Trials
state: Ontario
city: Chaidari
country: Greece
facility: Attikon General University Hospital
state: Attikí
city: Kaisariani
country: Greece
facility: Ionos Dragoumi 5 Kaisariani
state: Attikí
city: Athens
country: Greece
facility: Dermatological and Venereological Hospital Andreas Syggros
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Barcelona [barcelona]
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Taoyuan City
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch
state: Taoyuan
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: