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
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)
Prior exposure to Ebglyss; the cohort is limited to participants initiating Ebglyss
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
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)
Single group
Lebrikizumab-lbkz
Biological/VaccineLebrikizumab-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.
Proportion of participants achieving an Investigator's Global Assessment (IGA) score of 0 or 1
The IGA rates atopic dermatitis severity on a 5-point scale from 0 (clear) to 4 (severe); lower is better. This measure is the proportion of participants with IGA 0 (clear) or 1 (almost clear), analyzed separately from the itch measure.
Proportion of participants achieving a Pruritus Numeric Rating Scale (NRS) score ≤4
The Pruritus NRS rates worst itch over the past 24 hours from 0 (no itch) to 10 (worst imaginable itch); lower is better. This measure is the proportion of participants at or below the acceptable-control threshold of 4, analyzed separately from the skin measure.
Proportion of participants reaching and persisting at each Ebglyss dosing interval (every 2, 4, or 8 weeks) while maintaining disease control
Distribution of participants across the three labeled dosing intervals, counted as reaching and persisting at an interval (no re-escalation to a more frequent interval) while maintaining measure-based disease control (IGA 0-1 and Pruritus NRS ≤4 at the same assessment), using an on-treatment denominator. Week 56 is the principal timepoint; Week 24 is an early descriptive snapshot.
Proportion of participants achieving IGA 0 or 1 at Week 56
The IGA rates atopic dermatitis severity on a 5-point scale from 0 (clear) to 4 (severe); lower is better. This measure is the proportion of participants with IGA 0 (clear) or 1 (almost clear) at the end-of-study visit, analyzed separately from the itch measure.
Proportion of participants achieving Pruritus NRS ≤4 at Week 56
The Pruritus NRS rates worst itch over the past 24 hours from 0 (no itch) to 10 (worst imaginable itch); lower is better. This measure is the proportion of participants at or below the acceptable-control threshold of 4, analyzed separately from the skin measure.
Proportion achieving ≥4-point reduction from baseline in Pruritus NRS
The Pruritus NRS rates worst itch over the past 24 hours from 0 (no itch) to 10 (worst imaginable itch); lower is better. This measure is the proportion of participants achieving a reduction from baseline of at least 4 points, the responder threshold established in the lebrikizumab registrational program. All participants enter the study with a baseline Pruritus NRS greater than 4, so the ≥4-point reduction is achievable for every participant.
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Forefront Dermatology S.C
Lead sponsor
Eli Lilly and Company
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
