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

NCT07856134 | Not Yet Recruiting Phase 4 FDA Drug

• 2 other identifiers: AD-TEMPO-01Eli Lilly and Company
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 10

Brief 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

Conditions

Atopic Dermatitis

Keywords

Lebrikizumab; Ebglyss; Real-world evidence; IL-13; Adolescent; Dosing Interval

Outcome Measures

Primary Outcomes (2)

• 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.

  Week 24

• 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.

  Week 24

Secondary Outcomes (18)

• Proportion of participants reaching and persisting at each Ebglyss dosing interval (every 2, 4, or 8 weeks) while maintaining disease control

  Week 24 and Week 56

• Proportion of participants achieving IGA 0 or 1 at Week 56

  Week 56

• Proportion of participants achieving Pruritus NRS ≤4 at Week 56

  Week 56

• Proportion achieving ≥4-point reduction from baseline in Pruritus NRS

  Week 24 and Week 56

• Proportion achieving ≥3-point reduction from baseline in Pruritus NRS

  Week 24 and Week 56

Study Arms (1)

Lebrikizumab (open-label)

EXPERIMENTAL

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.

Biological: Lebrikizumab-lbkz

Interventions

Lebrikizumab-lbkz BIOLOGICAL

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.

Also known as: Lebrikizumab, Ebglyss

Lebrikizumab (open-label)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Forefront Dermatology S.C: lead
• Eli Lilly and Company: collaborator

Study Sites (10)

Advanced Dermatology & Skin Care Centre

Mobile, Alabama, 36695, United States

Location

Premier Dermatology

Crest Hill, Illinois, 60403, United States

Location

Lakeside Dermatology

Libertyville, Illinois, 60048, United States

Location

Forefront Dermatology - Grand Rapids

Grand Rapids, Michigan, 49546, United States

Location

Forefront Dermatology - St. Peters

City of Saint Peters, Missouri, 63376, United States

Location

Forefront Dermatology - Greensburg

Greensburg, Pennsylvania, 15601, United States

Location

Advanced Dermatology

Houston, Texas, 77084, United States

Location

Forefront Dermatology - Fairfax

Fairfax, Virginia, 22031, United States

Location

Forefront Dermatology - Vienna

Vienna, Virginia, 22182, United States

Location

Forefront Dermatology - Virginia Beach

Virginia Beach, Virginia, 23452, United States

Location

Related Publications (1)

• Silverberg JI, Guttman-Yassky E, Thaci D, Irvine AD, Stein Gold L, Blauvelt A, Simpson EL, Chu CY, Liu Z, Gontijo Lima R, Pillai SG, Seneschal J; ADvocate1 and ADvocate2 Investigators. Two Phase 3 Trials of Lebrikizumab for Moderate-to-Severe Atopic Dermatitis. N Engl J Med. 2023 Mar 23;388(12):1080-1091. doi: 10.1056/NEJMoa2206714. Epub 2023 Mar 15.

  PMID: 36920778 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

lebrikizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Diego Ruiz Dasilva, MD

  Forefront Dermatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tyler Stanier

CONTACT

805-440-8411; tyler.stanier@forefrontderm.com

Jennifer Peters

CONTACT

847-769-5025; Jennifer.Peters@Forefrontderm.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-group, open-label, pragmatic interventional design: all participants are assigned to lebrikizumab within the approved U.S. label, with every-2-week dosing through at least Week 16. The protocol does not assign the maintenance interval (every 2, 4, or 8 weeks). The treating clinician selects and adjusts it with the participant's input, within the label and the protocol's treatment rules. The study describes disease control at Week 24 and the resulting real-world distribution of dosing intervals and their drivers. There is no comparator arm and no randomization.

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): November 11, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)