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

28 września 2026 zaktualizowane przez: 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

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Atopowe zapalenie skóry

Interwencja / Leczenie

Biologiczny: Lebrikizumab-lbkz

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Szacowany)

250

Faza

Faza 4

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Nazwa: Tyler Stanier
Numer telefonu: 805-440-8411
E-mail: tyler.stanier@forefrontderm.com

Kopia zapasowa kontaktu do badania

Nazwa: Jennifer Peters
Numer telefonu: 847-769-5025
E-mail: Jennifer.Peters@Forefrontderm.com

Lokalizacje studiów

Stany Zjednoczone
- Alabama
  - Mobile, Alabama, Stany Zjednoczone, 36695
    - Advanced Dermatology & Skin Care Centre
    - Kontakt:
      
      Myia McMillian
      
      Numer telefonu: 28395 251-631-3570
      
      E-mail: myia.mcmillian@forefrontderm.com
    - Główny śledczy:
      
      Thomas Bender, MD
- Illinois
  - Crest Hill, Illinois, Stany Zjednoczone, 60403
    - Premier Dermatology
    - Kontakt:
      
      Ryan Fowler
      
      Numer telefonu: 23796 815-741-4343
      
      E-mail: myia.mcmillian@forefrontderm.com
    - Główny śledczy:
      
      Gregory Bezanis, MD
  - Libertyville, Illinois, Stany Zjednoczone, 60048
    - Lakeside Dermatology
    - Kontakt:
      
      Ronak Zareardalan
      
      Numer telefonu: 41665 847-367-5575
      
      E-mail: Ronak.Zareardalan@forefrontderm.com
    - Główny śledczy:
      
      Martha Arroyo, MD
- Michigan
  - Grand Rapids, Michigan, Stany Zjednoczone, 49546
    - Forefront Dermatology - Grand Rapids
    - Kontakt:
      
      Tyler Stanier
      
      Numer telefonu: 805-440-8411
      
      E-mail: tyler.stanier@forefrontderm.com
    - Główny śledczy:
      
      David Oberlin, MD
- Missouri
  - City of Saint Peters, Missouri, Stany Zjednoczone, 63376
    - Forefront Dermatology - St. Peters
    - Kontakt:
      
      Ty Simon
      
      Numer telefonu: 22193 636-277-0371
      
      E-mail: trever.simon@forefrontderm.com
    - Główny śledczy:
      
      Aaron Dwan, MD
- Pennsylvania
  - Greensburg, Pennsylvania, Stany Zjednoczone, 15601
    - Forefront Dermatology - Greensburg
    - Kontakt:
      
      Casey Moyer
      
      Numer telefonu: 22936 724-837-5810
      
      E-mail: casey.moyer@forefrontderm.com
    - Główny śledczy:
      
      Anthony Van Norman, MD
- Texas
  - Houston, Texas, Stany Zjednoczone, 77084
    - Advanced Dermatology
    - Kontakt:
      
      Syeda Fatima
      
      Numer telefonu: 45328 281-665-4444
      
      E-mail: syeda.fatima@forefrontderm.com
    - Główny śledczy:
      
      Haider Bangash, MD
- Virginia
  - Fairfax, Virginia, Stany Zjednoczone, 22031
    - Forefront Dermatology - Fairfax
    - Kontakt:
      
      Jackie Henley
      
      Numer telefonu: 22086 (703)-442-0301
      
      E-mail: jacqueline.henley@forefrontderm.com
    - Główny śledczy:
      
      Michele Magnino, MD
  - Vienna, Virginia, Stany Zjednoczone, 22182
    - Forefront Dermatology - Vienna
  - Virginia Beach, Virginia, Stany Zjednoczone, 23452
    - Forefront Dermatology - Virginia Beach
    - Kontakt:
      
      Sharon Brooks
      
      Numer telefonu: 757-467-3900
      
      E-mail: sharon.brooks@forefrontderm.com
    - Główny śledczy:
      
      Diego Ruiz Dasilva, MD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

12 lat i starsze (Dziecko, Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Główny cel: Leczenie
Przydział: Nie dotyczy
Model interwencyjny: Zadanie dla jednej grupy
Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm Grupa uczestników / Arm Grupa lub podgrupa uczestników badania klinicznego, którzy zgodnie z protokołem badania otrzymują określoną interwencję/leczenie lub nie otrzymują żadnej interwencji.	Interwencja / Leczenie Interwencja / Leczenie Proces lub działanie będące przedmiotem badania klinicznego. Interwencje obejmują leki, urządzenia medyczne, procedury, szczepionki i inne produkty, które są w fazie badań lub są już dostępne. Interwencje mogą również obejmować podejścia nieinwazyjne, takie jak edukacja lub modyfikacja diety i ćwiczeń.
Eksperymentalny: 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.	Biologiczny: 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. Inne nazwy: Ebglyss Lebrikizumab

Grupa uczestników / Arm

Interwencja / Leczenie

Eksperymentalny: 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.

Biologiczny: 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.

Inne nazwy:

Ebglyss
Lebrikizumab

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku	Opis środka	Ramy czasowe
Proportion of participants achieving an Investigator's Global Assessment (IGA) score of 0 or 1 Ramy czasowe: 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 Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku	Opis środka	Ramy czasowe
Proportion of participants reaching and persisting at each Ebglyss dosing interval (every 2, 4, or 8 weeks) while maintaining disease control Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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) Ramy czasowe: 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 Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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) Ramy czasowe: 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 Ramy czasowe: 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) Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Forefront Dermatology S.C

Współpracownicy

Eli Lilly and Company

Śledczy

Główny śledczy: Diego Ruiz Dasilva, MD, Forefront Dermatology

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

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.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

11 listopada 2026

Zakończenie podstawowe (Szacowany)

31 sierpnia 2027

Ukończenie studiów (Szacowany)

31 marca 2028

Daty rejestracji na studia

Pierwszy przesłany

28 września 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

28 września 2026

Pierwszy wysłany (Rzeczywisty)

2 października 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

2 października 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

28 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

AD-TEMPO-01
Eli Lilly and Company (Inny numer grantu/finansowania: Lilly IIR #78611)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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

Przegląd badań

Status

Warunki

Interwencja / Leczenie

Szczegółowy opis

Typ studiów

Zapisy (Szacowany)

Faza

Kontakty i lokalizacje

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

Kryteria uczestnictwa

Kryteria kwalifikacji

Wiek uprawniający do nauki

Akceptuje zdrowych ochotników

Płeć kwalifikująca się do nauki

Opis

Plan studiów

Jak projektuje się badanie?

Szczegóły projektu

Liczba ramion

Broń i interwencje

Grupa uczestników / Arm

Interwencja / Leczenie

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku

Opis środka

Ramy czasowe

Miary wyników drugorzędnych

Miara wyniku

Opis środka

Ramy czasowe

Współpracownicy i badacze

Sponsor

Współpracownicy

Śledczy

Publikacje i pomocne linki

Publikacje ogólne

Daty zapisu na studia

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

Zakończenie podstawowe (Szacowany)

Ukończenie studiów (Szacowany)

Daty rejestracji na studia

Pierwszy przesłany

Pierwszy przesłany, który spełnia kryteria kontroli jakości

Pierwszy wysłany (Rzeczywisty)

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

Ostatnia weryfikacja

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Bada produkt urządzenia regulowany przez amerykańską FDA

produkt wyprodukowany i wyeksportowany z USA