Atopic DermatitisPhase 4AD-TEMPONCT07856134
AD Treatment Optimization With Ebglyss in Real-World Practice: A Multicenter Study of Patient-Centered Outcomes
A Phase 4 study testing Lebrikizumab-lbkz in people with Atopic Dermatitis, run by Forefront Dermatology S.C at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Lebrikizumab-lbkz
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 10 sitesUnited States
- Study dates
- 11 Nov 2026to 31 Mar 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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 locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites
Forefront Dermatology - St. Peters
City of Saint Peters, Missouri, 63376
Ty Simon, 636-277-0371 ext. 22193, trever.simon@forefrontderm.com
Aaron Dwan, MD
Premier Dermatology
Crest Hill, Illinois, 60403
Ryan Fowler, 815-741-4343 ext. 23796, myia.mcmillian@forefrontderm.com
Gregory Bezanis, MD
Forefront Dermatology - Fairfax
Fairfax, Virginia, 22031
Jackie Henley, (703)-442-0301 ext. 22086, jacqueline.henley@forefrontderm.com
Michele Magnino, MD
Forefront Dermatology - Grand Rapids
Grand Rapids, Michigan, 49546
Tyler Stanier, 805-440-8411, tyler.stanier@forefrontderm.com
David Oberlin, MD
Forefront Dermatology - Greensburg
Greensburg, Pennsylvania, 15601
Casey Moyer, 724-837-5810 ext. 22936, casey.moyer@forefrontderm.com
Anthony Van Norman, MD
Advanced Dermatology
Houston, Texas, 77084
Syeda Fatima, 281-665-4444 ext. 45328, syeda.fatima@forefrontderm.com
Haider Bangash, MD
Lakeside Dermatology
Libertyville, Illinois, 60048
Ronak Zareardalan, 847-367-5575 ext. 41665, Ronak.Zareardalan@forefrontderm.com
Martha Arroyo, MD
Advanced Dermatology & Skin Care Centre
Mobile, Alabama, 36695
Myia McMillian, 251-631-3570 ext. 28395, myia.mcmillian@forefrontderm.com
Thomas Bender, MD
Forefront Dermatology - Vienna
Vienna, Virginia, 22182
Forefront Dermatology - Virginia Beach
Virginia Beach, Virginia, 23452
Sharon Brooks, 757-467-3900, sharon.brooks@forefrontderm.com
Diego Ruiz Dasilva, MD
About this study
Official title: 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.
Read more
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
Read the detailed 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.
- Conditions
- Atopic Dermatitis
- Being tested
- Lebrikizumab-lbkz
- Keywords
- Lebrikizumab, Ebglyss, Real-world evidence, IL-13, Adolescent, Dosing Interval
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lebrikizumab-lbkzBiological
Also called Lebrikizumab, Ebglyss
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Lebrikizumab-lbkz |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: Week 24 and Week 56
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.
Measured: Week 56
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.
Measured: Week 56
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.
Measured: Week 24 and Week 56
Proportion achieving ≥3-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 3 points, the instrument's minimal clinically important difference.
Measured: Week 24 and Week 56
Proportion achieving complete itch response (Pruritus NRS 0 or 1)
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 score of 0 or 1, representing complete or near-complete itch response.
Measured: Week 24 and Week 56
Proportion achieving IGA 0 or 1 with ≥2-point improvement from baseline
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 achieving IGA 0 or 1 with a reduction from baseline of at least 2 points, the primary responder definition of the ADvocate 1 and 2 registrational trials, assessed at the end of the induction period as a label-comparable benchmark. A sensitivity analysis counts participants who received systemic rescue therapy as non-responders, matching the registrational trials' convention
Measured: Week 16
Change from baseline in Patient-Oriented Eczema Measure (POEM)
The POEM is a 7-item patient-reported measure of eczema symptom frequency over the past week, scored 0 to 28; higher scores indicate greater severity, so lower is better and a negative change from baseline indicates improvement. Change from baseline is computed at each assessment; Week 24 and Week 56 are the principal timepoints for analysis.
Measured: Baseline to Week 56 (assessed at Weeks 4, 16, 24, 32, 40, 48, and 56)
Change from baseline in Dermatology Life Quality Index (DLQI)
The DLQI is a 10-item patient-reported measure of the impact of skin disease on quality of life over the past week, scored 0 to 30; higher scores indicate greater impairment, so lower is better and a negative change from baseline indicates improvement. Change from baseline is computed at each assessment; Week 24 and Week 56 are the principal timepoints for analysis. Participants aged 16 or younger at Baseline complete the Children's DLQI (CDLQI) instead.
Measured: Baseline to Week 56 (assessed at Weeks 4, 16, 24, 32, 40, 48, and 56)
Change from baseline in Work Productivity and Activity Impairment (WPAI) questionnaire
The WPAI measures the effect of atopic dermatitis on work and daily activities over the past 7 days, producing impairment scores expressed as percentages from 0% to 100%; higher percentages indicate greater impairment, so lower is better and a negative change from baseline indicates improvement. Change from baseline is computed at each assessment; Week 24 and Week 56 are the principal timepoints for analysis.
Measured: Baseline to Week 56 (assessed at Weeks 4, 16, 24, 32, 40, 48, and 56)
Change from baseline in Sleep-Loss Scale
The Sleep-Loss Scale is a single-item patient-reported rating of sleep loss due to itch interference during the previous night, scored 0 ('not at all') to 4 ('unable to sleep at all'); higher scores indicate greater sleep loss, so lower is better and a negative change from baseline indicates improvement. Change from baseline is computed at each assessment; Week 24 and Week 56 are the principal timepoints for analysis.
Measured: Baseline to Week 56 (assessed at Weeks 4, 16, 24, 32, 40, 48, and 56)
Change from baseline in Skin Pain Numeric Rating Scale (NRS)
The Skin Pain NRS rates worst skin pain over the past 24 hours from 0 (no pain) to 10 (worst imaginable pain); higher scores indicate greater pain, so lower is better and a negative change from baseline indicates improvement. Change from baseline is computed at each assessment; Week 24 and Week 56 are the principal timepoints for analysis.
Measured: Baseline to Week 56 (assessed at Weeks 4, 16, 24, 32, 40, 48, and 56)
Treatment persistence and dosing-interval change patterns
Descriptive characterization of Ebglyss treatment persistence and dosing-interval changes over the study, including time to first dosing-interval change, the number and direction of interval changes (extension to a less frequent interval or re-escalation to a more frequent interval), the documented clinical triggers for each change from the treatment-decision record, and time to and reasons for treatment discontinuation.
Measured: Baseline to Week 56
Treatment satisfaction, measured by the Treatment Satisfaction Questionnaire for Medication (TSQM-9)
The TSQM-9 is a 9-item patient-reported measure of satisfaction with medication, producing domain scores for effectiveness, convenience, and global satisfaction, each scaled 0 to 100; higher scores indicate greater satisfaction, so higher is better.
Measured: Weeks 16, 24, and 56
Change in patient-reported outcomes following a dosing-interval change
Change in Pruritus NRS, POEM, DLQI, Sleep-Loss Scale, and Skin Pain NRS from the in-clinic visit at which the Ebglyss dosing interval is changed to the next in-clinic visit, summarized by direction of change (extension to a less frequent interval or shortening to a more frequent interval).
Measured: Week 16 through Week 56
Adherence to the prescribed dosing interval
Proportion of expected Ebglyss injections recorded by participants in the monthly eSurvey relative to the dosing interval in effect, and proportion of participants with ≥80% adherence, by dosing interval (every 2, 4, or 8 weeks)
Measured: Baseline through Week 56
Topical therapy use
Participant-reported days in the past month using a medicated skin treatment for eczema (including over-the-counter hydrocortisone; excluding moisturizers), reported in categories: None, 1-3, 4-7, 8-14, 15-21, or 22 days or more. Collected at the Baseline visit (covering the month before Baseline) and at each monthly eSurvey. Change from Baseline to the induction period (Weeks 0-16) and the maintenance period (Weeks 16-56) is summarized by dosing interval.
Measured: Baseline through Week 56
Proportion of participants reporting no topical therapy use
Proportion of participants reporting no medicated skin treatment for eczema in the past month at each monthly eSurvey, by dosing interval.
Measured: Monthly, Week 4 through Week 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start11 Nov 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Forefront Dermatology S.C
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Diego Ruiz Dasilva, MD, Principal investigator, Forefront Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856134
- Sponsor's protocol ID
- AD-TEMPO-01
- Other IDs
- Eli Lilly and Company
- Acronym
- AD-TEMPO
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36920778
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07856134
- Acronym / sponsor ID
- AD-TEMPO / AD-TEMPO-01
- Conditions
- Atopic Dermatitis
- Keywords
- Lebrikizumab, Ebglyss, Real-world evidence, IL-13, Adolescent, Dosing Interval
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Forefront Dermatology S.CUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- 11 Nov 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Lebrikizumab (open-label) | Experimental | Biological: Lebrikizumab-lbkzAll 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lebrikizumab-lbkzAlso: Lebrikizumab, EbglyssLebrikizumab-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. | Biological | Lebrikizumab (open-label) |
Primary outcome
Proportion of participants achieving an Investigator's Global Assessment (IGA) score of 0 or 1
Time frame: Week 24
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
Time frame: Week 24
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.
18 secondary outcomes
Proportion of participants reaching and persisting at each Ebglyss dosing interval (every 2, 4, or 8 weeks) while maintaining disease control
Time frame: Week 24 and Week 56
Proportion of participants achieving IGA 0 or 1 at Week 56
Time frame: Week 56
Proportion of participants achieving Pruritus NRS ≤4 at Week 56
Time frame: Week 56
Proportion achieving ≥4-point reduction from baseline in Pruritus NRS
Time frame: Week 24 and Week 56
Proportion achieving ≥3-point reduction from baseline in Pruritus NRS
Time frame: Week 24 and Week 56
Proportion achieving complete itch response (Pruritus NRS 0 or 1)
Time frame: Week 24 and Week 56
Proportion achieving IGA 0 or 1 with ≥2-point improvement from baseline
Time frame: Week 16
Change from baseline in Patient-Oriented Eczema Measure (POEM)
Time frame: Baseline to Week 56 (assessed at Weeks 4, 16, 24, 32, 40, 48, and 56)
Change from baseline in Dermatology Life Quality Index (DLQI)
Time frame: Baseline to Week 56 (assessed at Weeks 4, 16, 24, 32, 40, 48, and 56)
Change from baseline in Work Productivity and Activity Impairment (WPAI) questionnaire
Time frame: Baseline to Week 56 (assessed at Weeks 4, 16, 24, 32, 40, 48, and 56)
Change from baseline in Sleep-Loss Scale
Time frame: Baseline to Week 56 (assessed at Weeks 4, 16, 24, 32, 40, 48, and 56)
Change from baseline in Skin Pain Numeric Rating Scale (NRS)
Time frame: Baseline to Week 56 (assessed at Weeks 4, 16, 24, 32, 40, 48, and 56)
Treatment persistence and dosing-interval change patterns
Time frame: Baseline to Week 56
Treatment satisfaction, measured by the Treatment Satisfaction Questionnaire for Medication (TSQM-9)
Time frame: Weeks 16, 24, and 56
Change in patient-reported outcomes following a dosing-interval change
Time frame: Week 16 through Week 56
Adherence to the prescribed dosing interval
Time frame: Baseline through Week 56
Topical therapy use
Time frame: Baseline through Week 56
Proportion of participants reporting no topical therapy use
Time frame: Monthly, Week 4 through Week 56
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Background: PubMed 36920778Silverberg 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.
- Individual participant dataSharing planned: No
Related trials for Atopic Dermatitis
RecruitingPhase 2
Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)
Enrolling by invitationPhase 3
A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis, Eczema
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
Active, not recruitingPhase 2
A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis
Atopic Dermatitis
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Diego Ruiz Dasilva, MD principal investigator
Forefront Dermatology
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lebrikizumab-lbkz in people with Atopic Dermatitis, run by Forefront Dermatology S.C at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tyler Stanier (805-440-8411, tyler.stanier@forefrontderm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving an Investigator's Global Assessment (IGA) score of 0 or 1 (time frame: Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07856134, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.