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

28. září 2026 aktualizováno: Forefront Dermatology S.C

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.

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

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

250

Fáze

  • Fáze 4

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Spojené státy
    • Alabama
      • Mobile, Alabama, Spojené státy, 36695
        • Advanced Dermatology & Skin Care Centre
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Thomas Bender, MD
    • Illinois
      • Crest Hill, Illinois, Spojené státy, 60403
        • Premier Dermatology
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Gregory Bezanis, MD
      • Libertyville, Illinois, Spojené státy, 60048
    • Michigan
      • Grand Rapids, Michigan, Spojené státy, 49546
        • Forefront Dermatology - Grand Rapids
        • Kontakt:
        • Vrchní vyšetřovatel:
          • David Oberlin, MD
    • Missouri
      • City of Saint Peters, Missouri, Spojené státy, 63376
        • Forefront Dermatology - St. Peters
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Aaron Dwan, MD
    • Pennsylvania
      • Greensburg, Pennsylvania, Spojené státy, 15601
        • Forefront Dermatology - Greensburg
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Anthony Van Norman, MD
    • Texas
      • Houston, Texas, Spojené státy, 77084
        • Advanced Dermatology
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Haider Bangash, MD
    • Virginia
      • Fairfax, Virginia, Spojené státy, 22031
        • Forefront Dermatology - Fairfax
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Michele Magnino, MD
      • Vienna, Virginia, Spojené státy, 22182
        • Forefront Dermatology - Vienna
      • Virginia Beach, Virginia, Spojené státy, 23452
        • Forefront Dermatology - Virginia Beach
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Diego Ruiz Dasilva, MD

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

12 let a starší (Dítě, Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Lebrikizumab (open-label)

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.
Biologický: Lebrikizumab-lbkz

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.

Ostatní jména:
  • Ebglyss
  • Lebrikizumab

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Proportion of participants achieving an Investigator's Global Assessment (IGA) score of 0 or 1
Časové okno: 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.
Week 24
Proportion of participants achieving a Pruritus Numeric Rating Scale (NRS) score ≤4
Časové okno: 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.
Week 24

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Proportion of participants reaching and persisting at each Ebglyss dosing interval (every 2, 4, or 8 weeks) while maintaining disease control
Časové okno: Week 24 and Week 56

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.
Week 24 and Week 56
Proportion of participants achieving IGA 0 or 1 at Week 56
Časové okno: 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.
Week 56
Proportion of participants achieving Pruritus NRS ≤4 at Week 56
Časové okno: 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.
Week 56
Proportion achieving ≥4-point reduction from baseline in Pruritus NRS
Časové okno: Week 24 and 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 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.
Week 24 and Week 56
Proportion achieving ≥3-point reduction from baseline in Pruritus NRS
Časové okno: Week 24 and 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 achieving a reduction from baseline of at least 3 points, the instrument's minimal clinically important difference.
Week 24 and Week 56
Proportion achieving complete itch response (Pruritus NRS 0 or 1)
Časové okno: Week 24 and 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 achieving a score of 0 or 1, representing complete or near-complete itch response.
Week 24 and Week 56
Proportion achieving IGA 0 or 1 with ≥2-point improvement from baseline
Časové okno: Week 16

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
Week 16
Change from baseline in Patient-Oriented Eczema Measure (POEM)
Časové okno: Baseline to Week 56 (assessed at Weeks 4, 16, 24, 32, 40, 48, and 56)

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.
Baseline to Week 56 (assessed at Weeks 4, 16, 24, 32, 40, 48, and 56)
Change from baseline in Dermatology Life Quality Index (DLQI)
Časové okno: Baseline to Week 56 (assessed at Weeks 4, 16, 24, 32, 40, 48, and 56)

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.
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
Časové okno: Baseline to Week 56 (assessed at Weeks 4, 16, 24, 32, 40, 48, and 56)

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.
Baseline to Week 56 (assessed at Weeks 4, 16, 24, 32, 40, 48, and 56)
Change from baseline in Sleep-Loss Scale
Časové okno: Baseline to Week 56 (assessed at Weeks 4, 16, 24, 32, 40, 48, and 56)

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.
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)
Časové okno: Baseline to Week 56 (assessed at Weeks 4, 16, 24, 32, 40, 48, and 56)

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.
Baseline to Week 56 (assessed at Weeks 4, 16, 24, 32, 40, 48, and 56)
Treatment persistence and dosing-interval change patterns
Časové okno: Baseline to Week 56

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.
Baseline to Week 56
Treatment satisfaction, measured by the Treatment Satisfaction Questionnaire for Medication (TSQM-9)
Časové okno: Weeks 16, 24, and 56

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.
Weeks 16, 24, and 56
Change in patient-reported outcomes following a dosing-interval change
Časové okno: Week 16 through Week 56

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).
Week 16 through Week 56
Adherence to the prescribed dosing interval
Časové okno: Baseline through Week 56

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)
Baseline through Week 56
Topical therapy use
Časové okno: Baseline through Week 56

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.
Baseline through Week 56
Proportion of participants reporting no topical therapy use
Časové okno: Monthly, Week 4 through Week 56

Proportion of participants reporting no medicated skin treatment for eczema in the past month at each monthly eSurvey, by dosing interval.
Monthly, Week 4 through Week 56

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Forefront Dermatology S.C

Spolupracovníci

Eli Lilly and Company

Vyšetřovatelé

  • Vrchní vyšetřovatel: Diego Ruiz Dasilva, MD, Forefront Dermatology

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

11. listopadu 2026

Primární dokončení (Odhadovaný)

31. srpna 2027

Dokončení studie (Odhadovaný)

31. března 2028

Termíny zápisu do studia

První předloženo

28. září 2026

První předloženo, které splnilo kritéria kontroly kvality

28. září 2026

První zveřejněno (Aktuální)

2. října 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

2. října 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

28. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • AD-TEMPO-01
  • Eli Lilly and Company (Jiné číslo grantu/financování: Lilly IIR #78611)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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