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NOT YET RECRUITING
NCT07856134
PHASE4

AD Treatment Optimization With Ebglyss in Real-World Practice: A Multicenter Study of Patient-Centered Outcomes

Sponsor: Forefront Dermatology S.C

View on ClinicalTrials.gov

Summary

The goal of this Phase 4 clinical study is to learn how Ebglyss (lebrikizumab) works and how it is dosed in everyday dermatology care for adults and adolescents (age 12 and older) with moderate-to-severe atopic dermatitis (eczema). Ebglyss is approved by the U.S. Food and Drug Administration, and its label allows maintenance injections every 2 weeks, every 4 weeks, or every 8 weeks. It is not yet known how doctors and patients choose among these options in real-world practice. The study is for patients whose doctor has already decided, as part of their regular care, to start Ebglyss. The study is offered only after that decision is made. The main questions this study aims to answer are: How many participants have clear or almost clear skin, and how many have their itch under control, 24 weeks after starting Ebglyss? What portion of participants are on each dosing schedule (every 2, 4, or 8 weeks) at the end of the 56-week study, and how long do they stay on it? Why do doctors and patients keep or change the dosing schedule over time? All participants receive open-label Ebglyss, used within its FDA-approved label. There is no placebo or comparison group. After the first 16 weeks of standard dosing, the study doctor chooses the dosing schedule with the participant's input, following the label and the study's treatment rules, and records the reason for each decision. Participants will: * Receive Ebglyss, provided at no cost during the study * Attend 8 clinic visits over 56 weeks (about 13 months) * Answer questionnaires at visits about itch, sleep, skin symptoms, and quality of life * Complete a short online survey each month from home

Official title: A Phase 4, Prospective, Multicenter, Single-Arm, Pragmatic Interventional Cohort Study Evaluating Real-World Outcomes and Dosing Patterns of Ebglyss (Lebrikizumab) in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2026-11-11

Completion Date

2028-03-31

Last Updated

2026-10-02

Healthy Volunteers

No

Interventions

BIOLOGICAL

Lebrikizumab-lbkz

Lebrikizumab-lbkz 250 mg/2 mL solution in a single-dose prefilled pen, given by subcutaneous injection per the approved U.S. label: 500 mg (two 250 mg injections) at Week 0 and Week 2, then 250 mg every 2 weeks through at least Week 16. Maintenance is 250 mg every 4 or 8 weeks, or every 2 weeks continued, selected by the treating clinician at study visits within the label and the protocol's treatment rules. Supplied by Eli Lilly and Company. The first dose is given in clinic with injection training; participants then self-administer at home.

Locations (10)

Advanced Dermatology & Skin Care Centre

Mobile, Alabama, United States

Premier Dermatology

Crest Hill, Illinois, United States

Lakeside Dermatology

Libertyville, Illinois, United States

Forefront Dermatology - Grand Rapids

Grand Rapids, Michigan, United States

Forefront Dermatology - St. Peters

City of Saint Peters, Missouri, United States

Forefront Dermatology - Greensburg

Greensburg, Pennsylvania, United States

Advanced Dermatology

Houston, Texas, United States

Forefront Dermatology - Fairfax

Fairfax, Virginia, United States

Forefront Dermatology - Vienna

Vienna, Virginia, United States

Forefront Dermatology - Virginia Beach

Virginia Beach, Virginia, United States