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

Forefront Dermatology S.C

Status and phase: Begins enrollment in 1 month; Phase 4

Conditions: Atopic Dermatitis

Treatments: Biological: Lebrikizumab-lbkz

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07856134

AD-TEMPO-01

Eli Lilly and Company (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full description

AD-TEMPO is a Phase 4, prospective, multicenter, single-arm, pragmatic interventional study of Ebglyss (lebrikizumab-lbkz) in moderate-to-severe atopic dermatitis, designed to characterize real-world outcomes and dosing patterns. All participants are assigned to open-label Ebglyss, used within the approved U.S. label: induction dosing, then maintenance every 2 weeks through at least Week 16. After that, the treating clinician selects and adjusts the maintenance interval (every 2, 4, or 8 weeks) with the participant's input, within the label and the protocol's treatment rules. These rules include a recommended approach to loss of disease control, limits on short-course systemic rescue therapy, and prohibited therapies. Topical therapy is permitted throughout.

Participants are assessed at Baseline and at Weeks 4, 16, 24, 32, 40, 48, and 56, with a monthly remote eSurvey between visits recording injection dates and topical therapy use. At every visit from Week 4, whether or not treatment changes, a structured record captures the clinician's recommendation, its clinical rationale, and the participant's perspective. This allows dosing-interval trajectories and their drivers to be described over 56 weeks.

Eligible participants are 12 years of age or older and weigh at least 40 kg. They have moderate-to-severe atopic dermatitis (Investigator's Global Assessment ≥3 and Pruritus NRS >4 at Baseline), and their treating clinician has recommended Ebglyss before, and separately from, any discussion of the study. Enrollment of participants with prior biologic or JAK-inhibitor experience is capped at 30%. Clinician-rated assessments (Investigator's Global Assessment, body surface area) and patient-reported outcomes (POEM, Pruritus NRS, DLQI, and others) are collected at each visit using an electronic source data platform. No study-mandated laboratory testing or imaging is required. Care outside study assessments follows routine practice, and unscheduled visits are recorded as they occur.

The primary outcome measures, analyzed separately, are the proportion of participants achieving IGA 0-1 and the proportion achieving Pruritus NRS ≤4 at Week 24. The key secondary outcome is the proportion of participants who reach and remain on each dosing interval through Weeks 24 and 56 while maintaining disease control; Week 56 is the principal timepoint. Other outcomes include dosing-interval change patterns and associated clinical and patient-reported outcomes. Study drug is provided by Eli Lilly and Company at no cost to participants.

Enrollment: 250 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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)
• Concurrent enrollment in an interventional clinical trial of an investigational agent for atopic dermatitis
• 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)
• 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
• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

Lebrikizumab (open-label)

Experimental group

Description:

All participants receive open-label lebrikizumab-lbkz (Ebglyss) by subcutaneous injection within 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 then 250 mg every 4 weeks or every 8 weeks, or every 2 weeks continued for inadequate response. The treating clinician selects the maintenance interval, and any later change, at study visits with the participant's input, within the label and the protocol's treatment rules. The protocol does not assign the interval. Each interval decision and its rationale are recorded. The first dose is given in clinic at Baseline with injection training; study drug is then dispensed at visits for self-administration at home.

Treatment:

Biological: Lebrikizumab-lbkz