Ebglyss for Moderate-to-Severe Eczema in Everyday Dermatology Care, Including Dosing Choices

Trial details

Who runs it

Forefront Dermatology S.C

Trial code

NCT07856134

Record updated

2 October 2026

Original description

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.Read full original descriptionShow less

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

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

Inclusion: Aged 12 years or older and weighing at least 40 kg at the time of consent (the approved Ebglyss population); Atopic dermatitis diagnosed per American Academy of Dermatology consensus criteria, and, in the treating clinician's judgment independent of the study, a candidate for advanced systemic therapy per AAD guidelines; Treating clinician has recommended initiation of Ebglyss, used on-label, as part of routine clinical care, and the participant is appropriate for Ebglyss per the current prescribing information; Baseline Investigator's Global Assessment (IGA) score of 3 or greater (moderate-to-severe disease); Baseline Pruritus Numeric Rating Scale (NRS) score greater than 4; Willing and able to complete patient-reported outcomes and the monthly remote eSurvey, and to comply with the visit schedule; Able to provide written informed consent and HIPAA authorization prior to any study-related procedure; for minors, written parental/guardian permission and age-appropriate assent are obtained as required by the reviewing IRB.

Exclusion: Prior exposure to Ebglyss; the cohort is limited to participants initiating Ebglyss; Ongoing use, at enrollment, of another advanced systemic therapy for atopic dermatitis (a short course of an oral corticosteroid, cyclosporine, or an oral JAK inhibitor in progress at enrollment does not exclude a participant if its total duration does not exceed 14 days; phototherapy must be discontinued before the Baseline visit); Concurrent enrollment in an interventional clinical trial of an investigational agent for atopic dermatitis; Inability or unwillingness to provide informed consent or to comply with study requirements; Note: No minimum body surface area is required. No protocol-mandated washout is imposed; transitions from prior systemic therapy follow the treating clinician's standard practice. Enrollment of participants with prior biologic or oral JAK inhibitor experience is capped at 30% of the cohort; Known serious hypersensitivity to Ebglyss or to any of its excipients; Known, untreated helminth (parasitic) infection; participants may be reconsidered once the infection has been treated; Any medical, psychiatric, or social condition that, in the investigator's opinion, would confound interpretation of the data or interfere significantly with completion of study assessments; Pregnancy or breastfeeding at the time of enrollment (applies at enrollment only; assessed by clinical evaluation and self-report, with no protocol-mandated pregnancy testing).

ClinicalTrials.gov NCT07856134