Ebglyss for Atopic Dermatitis
(AD-TEMPO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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
Who Is on the Research Team?
Diego Ruiz Dasilva, MD
Principal Investigator
Forefront Dermatology
Are You a Good Fit for This Trial?
This trial is for people age 12 and older with moderate-to-severe eczema (atopic dermatitis) whose doctor has already decided they should start Ebglyss (lebrikizumab) as part of their regular care.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Lebrikizumab-lbkz
Trial Overview
The study looks at how well Ebglyss works in real-world use, tracking skin improvement and itch control. All participants get Ebglyss injections on a schedule chosen by them and their doctor—every 2, 4, or 8 weeks—for about a year. There is no placebo group.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Forefront Dermatology S.C
Lead Sponsor
Eli Lilly and Company
Industry Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University
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