AD Treatment Optimization With Ebglyss in Real-World Practice: A Multicenter Study of Patient-Centered Outcomes (AD-TEMPO)
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
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 4단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Tyler Stanier
- 전화번호: 805-440-8411
- 이메일: tyler.stanier@forefrontderm.com
연구 연락처 백업
- 이름: Jennifer Peters
- 전화번호: 847-769-5025
- 이메일: Jennifer.Peters@Forefrontderm.com
연구 장소
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Alabama
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Mobile, Alabama, 미국, 36695
- Advanced Dermatology & Skin Care Centre
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연락하다:
- Myia McMillian
- 전화번호: 28395 251-631-3570
- 이메일: myia.mcmillian@forefrontderm.com
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수석 연구원:
- Thomas Bender, MD
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Illinois
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Crest Hill, Illinois, 미국, 60403
- Premier Dermatology
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연락하다:
- Ryan Fowler
- 전화번호: 23796 815-741-4343
- 이메일: myia.mcmillian@forefrontderm.com
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수석 연구원:
- Gregory Bezanis, MD
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Libertyville, Illinois, 미국, 60048
- Lakeside Dermatology
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연락하다:
- Ronak Zareardalan
- 전화번호: 41665 847-367-5575
- 이메일: Ronak.Zareardalan@forefrontderm.com
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수석 연구원:
- Martha Arroyo, MD
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Michigan
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Grand Rapids, Michigan, 미국, 49546
- Forefront Dermatology - Grand Rapids
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연락하다:
- Tyler Stanier
- 전화번호: 805-440-8411
- 이메일: tyler.stanier@forefrontderm.com
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수석 연구원:
- David Oberlin, MD
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Missouri
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City of Saint Peters, Missouri, 미국, 63376
- Forefront Dermatology - St. Peters
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연락하다:
- Ty Simon
- 전화번호: 22193 636-277-0371
- 이메일: trever.simon@forefrontderm.com
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수석 연구원:
- Aaron Dwan, MD
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Pennsylvania
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Greensburg, Pennsylvania, 미국, 15601
- Forefront Dermatology - Greensburg
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연락하다:
- Casey Moyer
- 전화번호: 22936 724-837-5810
- 이메일: casey.moyer@forefrontderm.com
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수석 연구원:
- Anthony Van Norman, MD
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Texas
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Houston, Texas, 미국, 77084
- Advanced Dermatology
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연락하다:
- Syeda Fatima
- 전화번호: 45328 281-665-4444
- 이메일: syeda.fatima@forefrontderm.com
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수석 연구원:
- Haider Bangash, MD
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Virginia
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Fairfax, Virginia, 미국, 22031
- Forefront Dermatology - Fairfax
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연락하다:
- Jackie Henley
- 전화번호: 22086 (703)-442-0301
- 이메일: jacqueline.henley@forefrontderm.com
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수석 연구원:
- Michele Magnino, MD
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Vienna, Virginia, 미국, 22182
- Forefront Dermatology - Vienna
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Virginia Beach, Virginia, 미국, 23452
- Forefront Dermatology - Virginia Beach
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연락하다:
- Sharon Brooks
- 전화번호: 757-467-3900
- 이메일: sharon.brooks@forefrontderm.com
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수석 연구원:
- Diego Ruiz Dasilva, MD
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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. |
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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of participants achieving an Investigator's Global Assessment (IGA) score of 0 or 1
기간: Week 24
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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
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Proportion of participants achieving a Pruritus Numeric Rating Scale (NRS) score ≤4
기간: Week 24
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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
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of participants reaching and persisting at each Ebglyss dosing interval (every 2, 4, or 8 weeks) while maintaining disease control
기간: Week 24 and Week 56
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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
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Proportion of participants achieving IGA 0 or 1 at Week 56
기간: Week 56
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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
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Proportion of participants achieving Pruritus NRS ≤4 at Week 56
기간: Week 56
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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
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Proportion achieving ≥4-point reduction from baseline in Pruritus NRS
기간: Week 24 and Week 56
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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
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Proportion achieving ≥3-point reduction from baseline in Pruritus NRS
기간: Week 24 and Week 56
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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
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Proportion achieving complete itch response (Pruritus NRS 0 or 1)
기간: Week 24 and Week 56
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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
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Proportion achieving IGA 0 or 1 with ≥2-point improvement from baseline
기간: Week 16
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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
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Change from baseline in Patient-Oriented Eczema Measure (POEM)
기간: Baseline to Week 56 (assessed at Weeks 4, 16, 24, 32, 40, 48, and 56)
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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)
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Change from baseline in Dermatology Life Quality Index (DLQI)
기간: Baseline to Week 56 (assessed at Weeks 4, 16, 24, 32, 40, 48, and 56)
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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)
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Change from baseline in Work Productivity and Activity Impairment (WPAI) questionnaire
기간: Baseline to Week 56 (assessed at Weeks 4, 16, 24, 32, 40, 48, and 56)
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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)
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Change from baseline in Sleep-Loss Scale
기간: Baseline to Week 56 (assessed at Weeks 4, 16, 24, 32, 40, 48, and 56)
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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)
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Change from baseline in Skin Pain Numeric Rating Scale (NRS)
기간: Baseline to Week 56 (assessed at Weeks 4, 16, 24, 32, 40, 48, and 56)
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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)
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Treatment persistence and dosing-interval change patterns
기간: Baseline to Week 56
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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
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Treatment satisfaction, measured by the Treatment Satisfaction Questionnaire for Medication (TSQM-9)
기간: Weeks 16, 24, and 56
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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
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Change in patient-reported outcomes following a dosing-interval change
기간: Week 16 through Week 56
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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
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Adherence to the prescribed dosing interval
기간: Baseline through Week 56
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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
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Topical therapy use
기간: Baseline through Week 56
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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
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Proportion of participants reporting no topical therapy use
기간: Monthly, Week 4 through Week 56
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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
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공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Diego Ruiz Dasilva, MD, Forefront Dermatology
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- AD-TEMPO-01
- Eli Lilly and Company (기타 보조금/기금 번호: Lilly IIR #78611)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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