Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Este Estudo é um Registo de Doença Não Intervencionista de Doentes Adolescentes e Adultos com Dermatite Atópica que Iniciam ou Alteram Qualquer Tratamento Sistémico (ARMADA-AD)

30 de outubro de 2026 atualizado por: Sanofi

Registo de Doença de Dermatite Atópica de Pacientes Adultos e Adolescentes que Iniciam ou Mudam Tratamentos Sistémicos

The objectives of this prospective non-interventional study are to characterize the existing unmet needs across the spectrum of atopic dermatitis (AD), enhance the understanding of the patient journey, and evaluate the safety and clinical outcomes of systemic AD treatments in a real-world setting. Additionally, patient-specific factors (such as age, skin color, AD flare triggers, previous treatment responses, comorbid conditions, and the extent and site of lesions) will be assessed to better characterize the impact on the treatment journey across a broad age range and diverse geographic regions.

The study will be conducted across 10 countries in 4 different geographical regions, with a follow-up period of 5 years.

Visão geral do estudo

Status

Recrutamento

Condições

Tipo de estudo

Observacional

Inscrição (Estimado)

1000

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Trial Transparency email recommended (Toll free for US & Canada)
  • Número de telefone: option 6 800-633-1610
  • E-mail: Contact-US@sanofi.com

Locais de estudo

  • Arábia Saudita
      • Jeddah, Arábia Saudita, 21452
        • Recrutamento
        • Erfan and Bagedo Hospital-Site Number : 6820002
        • Contato:
        • Investigador principal:
          • Ahmed Ismail Ebraheem Abdellateef
      • Jeddah, Arábia Saudita, 23421
        • Recrutamento
        • Medical Fakeeh-Site Number : 6820003
        • Contato:
        • Investigador principal:
          • Ayman Elgendi
      • Riyadh, Arábia Saudita, 12231
        • Recrutamento
        • King Fahad Medical City-Site Number : 6820001
        • Contato:
        • Investigador principal:
          • Mohammed Alajlan
  • Canadá
    • Saskatchewan
      • Regina, Saskatchewan, Canadá, S4V 1R9
        • Recrutamento
        • Origins Dermatology Centre-Site Number : 1240003
        • Investigador principal:
          • Rachel Asiniwasis
        • Contato:
  • China
      • Chongqing, China, 400016
        • Recrutamento
        • The First Affiliated Hospital of Chongqing Medical University-Site Number : 1560011
        • Contato:
        • Investigador principal:
          • Tao Cai
      • Shanghai, China, 200040
        • Recrutamento
        • Huashan Hospital, Fudan University-Site Number: 1560012
        • Investigador principal:
          • Wei Li
        • Contato:
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100191
        • Recrutamento
        • Peking University Third Hospital-Site Number: 1560008
        • Investigador principal:
          • Wenhui Wang
        • Contato:
    • Guangdong
      • Shenzhen, Guangdong, China, 518033
        • Recrutamento
        • The Eighth Affiliated Hospital, Sun Yat-sen University-Site Number: 1560006
        • Contato:
        • Investigador principal:
          • Peimei Zhou
    • Hu'nan
      • Changsha, Hu'nan, China, 410008
        • Recrutamento
        • Xiangya Hospital of Central South University-Site Number : 1560001
        • Investigador principal:
          • Juan Su
        • Contato:
      • Changsha, Hu'nan, China, 410011
        • Recrutamento
        • The Second Xiangya Hospital of Central South University-Site Number: 1560014
        • Investigador principal:
          • Yunsheng Liang
        • Contato:
    • Shanxi
      • Xi’an, Shanxi, China, 710004
        • Recrutamento
        • The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)-Site Number: 1560002
        • Investigador principal:
          • Songmei Geng
        • Contato:
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recrutamento
        • West China Hospital, Sichuan University- Site Number: 1560003
        • Investigador principal:
          • Jingyi Li
        • Contato:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • Recrutamento
        • Hangzhou First People's Hospital-Site Number: 1560004
        • Investigador principal:
          • Liming Wu
        • Contato:
      • Hangzhou, Zhejiang, China, 310009
        • Recrutamento
        • The Second Affiliated Hospital of Zhejiang University School of Medicine-Site Number: 1560007
        • Investigador principal:
          • Xiaoyong Man
        • Contato:
      • Ningbo, Zhejiang, China, 315010
        • Recrutamento
        • The First Affiliated Hospital of Ningbo University-Site Number : 1560009
        • Contato:
        • Investigador principal:
          • Bingjiang Lin
  • Emirados Árabes Unidos
      • Abu Dhabi, Emirados Árabes Unidos, 66566
        • Recrutamento
        • Mediclinic Hospital, AUH-Site Number: 7840004
        • Contato:
        • Investigador principal:
          • Hussein Abdel Dayem
      • Abu Dhabi, Emirados Árabes Unidos, 6222
        • Recrutamento
        • NMC Specialty Hospital-Site Number : 7840002
        • Contato:
        • Investigador principal:
          • Ahmed Ameen
      • Al Karama, Emirados Árabes Unidos, 50730
        • Recrutamento
        • Dr Joseph Polyclinic Amber Clinic-Site Number: 7840005
        • Contato:
        • Investigador principal:
          • Srikumar Goturu
      • Dubai, Emirados Árabes Unidos, 00000
        • Recrutamento
        • Dermatology and Aesthetic Center Rashid Hospital-Site Number : 7840003
        • Contato:
        • Investigador principal:
          • Amani Abdulla Rahma Alfalasi
  • Espanha
      • Alicante, Espanha, 03010
        • Recrutamento
        • Hospital General Universitario Dr. Balmis-Site Number: 7240005
        • Investigador principal:
          • Juan Francisco Silvestre Salvador
        • Contato:
    • Catalunya [Cataluña]
      • Barcelona, Catalunya [Cataluña], Espanha, 08041
        • Recrutamento
        • Investigational Site Number : 7240006
    • Tenerife
      • Santa Cruz de Tenerife, Tenerife, Espanha, 38320
        • Recrutamento
        • Hospital Universitario de Canarias-Site Number: 7240008
        • Investigador principal:
          • Ruperto Gonzalez Perez
        • Contato:
  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35244
        • Recrutamento
        • Cahaba Dermatology & Skin Health Center- Site Number : 8400006
        • Investigador principal:
          • Vlada Groysman
        • Contato:
      • Montgomery, Alabama, Estados Unidos, 36117
        • Recrutamento
        • River Region Dermatology and Laser- Site Number : 8400041
        • Investigador principal:
          • Porcia Love
        • Contato:
    • Arizona
      • Gilbert, Arizona, Estados Unidos, 85234
        • Recrutamento
        • San Tan Allergy & Asthma- Site Number : 8400031
        • Contato:
        • Investigador principal:
          • Sam Reed Shimamoto
      • Phoenix, Arizona, Estados Unidos, 85008
        • Recrutamento
        • Saguaro Dermatology- Site Number : 8400028
        • Investigador principal:
          • Dathan Hamann
        • Contato:
    • California
      • Bakersfield, California, Estados Unidos, 93301
        • Recrutamento
        • Kern Research, Inc.- Site Number : 8400047
        • Investigador principal:
          • Tonny Tanus
        • Contato:
      • Fremont, California, Estados Unidos, 94538
        • Recrutamento
        • Center for Dermatology Clinical Research- Site Number : 8400014
        • Investigador principal:
          • Sunil Dhawan
        • Contato:
      • Los Angeles, California, Estados Unidos, 90045
        • Recrutamento
        • Dermatology Research Associates - Los Angeles- Site Number : 8400020
        • Investigador principal:
          • Howard Sofen
        • Contato:
      • Northridge, California, Estados Unidos, 91325
        • Recrutamento
        • Northridge Clinical Trials, LLC- Site Number : 8400009
        • Investigador principal:
          • Navid Ezra
        • Contato:
      • Oakland, California, Estados Unidos, 94596
        • Recrutamento
        • Sunwise Clinical Research, LLC.- Site Number : 8400010
        • Contato:
        • Investigador principal:
          • Michael Abdel Malek
      • Pomona, California, Estados Unidos, 91767
        • Recrutamento
        • Empire Clinical Research, LLC- Site Number : 8400007
        • Contato:
          • Usha Mantha
        • Investigador principal:
          • Usha Mantha
      • San Diego, California, Estados Unidos, 92123
        • Recrutamento
        • University Clinical Trials- Site Number : 8400019
        • Investigador principal:
          • Walter Nahm
        • Contato:
    • Colorado
      • Wheat Ridge, Colorado, Estados Unidos, 80033
        • Recrutamento
        • Western States Clinical Research, Inc.- Site Number : 8400051
        • Investigador principal:
          • Jeffrey Rumbyrt
        • Contato:
    • Florida
      • Doral, Florida, Estados Unidos, 33172
        • Recrutamento
        • St. Jude Clinical Research- Site Number : 8400049
        • Contato:
        • Investigador principal:
          • Gustavo Torres
      • North Miami Beach, Florida, Estados Unidos, 33162-4708
        • Recrutamento
        • Ziaderm Research, LLC- Site Number : 8400021
        • Investigador principal:
          • Tory Sullivan
        • Contato:
    • Georgia
      • Macon, Georgia, Estados Unidos, 31217
        • Recrutamento
        • Skin Care Physicians of Georgia - Macon- Site Number : 8400034
        • Investigador principal:
          • David Cohen
        • Contato:
    • Illinois
      • Normal, Illinois, Estados Unidos, 61761
        • Recrutamento
        • Sneeze, Wheeze, & Itch Associates, LLC- Site Number : 8400029
        • Investigador principal:
          • Dareen Siri
        • Contato:
      • North Chicago, Illinois, Estados Unidos, 60064
        • Recrutamento
        • Rosalind Franklin University of Medicine and Science- Site Number: 8400056
        • Investigador principal:
          • Raj Chovatiya
        • Contato:
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48103
        • Recrutamento
        • David Fivenson, MD, Dermatology, PLLC- Site Number : 8400017
        • Investigador principal:
          • David Fivenson
        • Contato:
      • Auburn Hills, Michigan, Estados Unidos, 48326
        • Recrutamento
        • Oakland Hills Dermatology- Site Number : 8400042
        • Investigador principal:
          • Christofer Buatti
        • Contato:
      • Bay City, Michigan, Estados Unidos, 48706
        • Recrutamento
        • Great Lakes Research Group - Bay City- Site Number : 8400052
        • Investigador principal:
          • Brent Boyce
        • Contato:
      • Caledonia, Michigan, Estados Unidos, 49316
        • Recrutamento
        • The Derm Institute of West Michigan- Site Number : 8400025
        • Investigador principal:
          • Kristi Hawley
        • Contato:
        • Contato:
      • Detroit, Michigan, Estados Unidos, 48201
        • Recrutamento
        • Wayne State University - Detroit Medical Center- Site Number : 8400035
        • Investigador principal:
          • Steven Daveluy
        • Contato:
      • Waterford, Michigan, Estados Unidos, 48328
        • Recrutamento
        • Michigan Dermatology Institute - Waterford- Site Number : 8400013
        • Contato:
        • Investigador principal:
          • Cory Rubin
    • Missouri
      • Bolivar, Missouri, Estados Unidos, 65613
        • Recrutamento
        • Red River Research Partners, Llc- Site Number : 8400054
        • Contato:
        • Investigador principal:
          • Murphy Mastin
      • Kirksville, Missouri, Estados Unidos, 63501
        • Recrutamento
        • Cleaver Dermatology- Site Number : 8400033
        • Contato:
        • Investigador principal:
          • David Cleaver
    • Nebraska
      • Lincoln, Nebraska, Estados Unidos, 68510
        • Recrutamento
        • Allergy Asthma & Immunology- Site Number : 8400044
        • Investigador principal:
          • Robert Szalewski
        • Contato:
    • Nevada
      • Las Vegas, Nevada, Estados Unidos, 89144
        • Recrutamento
        • Las Vegas Dermatology- Site Number : 8400002
        • Investigador principal:
          • Harry Greenberg
        • Contato:
    • New Hampshire
      • Portsmouth, New Hampshire, Estados Unidos, 03801
        • Recrutamento
        • Optima Research Portsmouth- Site Number : 8400032
        • Investigador principal:
          • Abel Jarell
        • Contato:
    • New Mexico
      • Albuquerque, New Mexico, Estados Unidos, 87106
        • Recrutamento
        • University Of New Mexico School Of Medicine- Site Number : 8400022
    • North Carolina
      • Huntersville, North Carolina, Estados Unidos, 28078
        • Recrutamento
        • Piedmont Plastic Surgery and Dermatology- Site Number : 8400038
        • Contato:
        • Investigador principal:
          • Nicole Seminara Zambrzycka
      • Winston-Salem, North Carolina, Estados Unidos, 27104
        • Recrutamento
        • Wake Forest University Health Sciences- Site Number : 8400003
        • Investigador principal:
          • Steven Feldman
        • Contato:
    • North Dakota
      • Fargo, North Dakota, Estados Unidos, 58103
        • Recrutamento
        • Red River Research Partners - Fargo- Site Number : 8400037
        • Investigador principal:
          • Michael Blankinship
        • Contato:
    • Ohio
      • Marion, Ohio, Estados Unidos, 43302
        • Recrutamento
        • Dermatology Associates of Mid-Ohio- Site Number : 8400026
        • Contato:
          • George Scott Drew
          • Número de telefone: 740-244-8559
          • E-mail: spfxv@aol.com
        • Investigador principal:
          • George Scott Drew
      • Mason, Ohio, Estados Unidos, 45040
        • Recrutamento
        • Dermatologists of Southwest Ohio - Mason- Site Number : 8400050
        • Investigador principal:
          • Rocco Serrao
        • Contato:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Estados Unidos, 15213
        • Recrutamento
        • UPMC - Department of Dermatology- Site Number : 8400024
        • Investigador principal:
          • Joe Tung
        • Contato:
    • Rhode Island
      • Warwick, Rhode Island, Estados Unidos, 02886
        • Recrutamento
        • Care Access Research - Warwick 2- Site Number : 8400045
        • Contato:
        • Investigador principal:
          • John Zwetchkenbaum
    • South Carolina
      • Spartanburg, South Carolina, Estados Unidos, 29307
        • Recrutamento
        • Advanced Dermatology and Cosmetic Surgery - Spartanburg- Site Number : 8400004
        • Contato:
        • Investigador principal:
          • Amylynne Frankel
    • Texas
      • Dallas, Texas, Estados Unidos, 75235
        • Recrutamento
        • Reveal Research Institute - Dallas- Site Number : 8400012
        • Investigador principal:
          • Aaron Farberg
        • Contato:
      • Fort Worth, Texas, Estados Unidos, 76244
        • Concluído
        • Innovate Research - Fort Worth- Site Number : 8400016
      • Pflugerville, Texas, Estados Unidos, 78660
        • Recrutamento
        • Austin Institute for Clinical Research, Inc- Site Number : 8400030
        • Investigador principal:
          • Edward Lain
        • Contato:
      • Sugar Land, Texas, Estados Unidos, 77479
        • Recrutamento
        • Complete Dermatology - Sugar Land- Site Number : 8400001
        • Investigador principal:
          • Bartley Gill
        • Contato:
    • Utah
      • Bountiful, Utah, Estados Unidos, 84010
        • Recrutamento
        • Cope Family Medicine - Ogden Clinic- Site Number : 8400053
      • Springville, Utah, Estados Unidos, 84663
        • Recrutamento
        • Springville Dermatology - Springville- Site Number : 8400055
        • Contato:
        • Investigador principal:
          • Michael Peterson
    • Virginia
      • Falls Church, Virginia, Estados Unidos, 22042
        • Recrutamento
        • Fuchs Dermatology- Site Number : 8400027
        • Contato:
        • Investigador principal:
          • Aaron Fuchs
    • Washington
      • Mill Creek, Washington, Estados Unidos, 98012
        • Recrutamento
        • Frontier Dermatology Partners CRO LLC- Site Number : 8400011
        • Contato:
        • Investigador principal:
          • Eingun James Song
      • Seattle, Washington, Estados Unidos, 98105
        • Recrutamento
        • University of Washington - Roosevelt Location- Site Number : 8400005
        • Contato:
        • Investigador principal:
          • Vivian Shi
  • França
    • Doubs
      • Besançon, Doubs, França, 25030
        • Recrutamento
        • CHU Besançon - Hôpital Jean Minjoz-Site Number: 2500010
        • Investigador principal:
          • Francois Aubin
        • Contato:
    • Drome
      • Valence, Drome, França, 26000
        • Recrutamento
        • Centre Hospitalier de Valence-Site Number: 2500005
        • Contato:
        • Investigador principal:
          • Anne Grange
    • Haut Rhin
      • Mulhouse, Haut Rhin, França, 68100
        • Recrutamento
        • GHRMSA - Hospital Emile Muller-Site Number : 2500006
        • Contato:
        • Investigador principal:
          • Catherine Michel
    • Reunion
      • Saint-Pierre, Reunion, França, 97448
        • Recrutamento
        • CHU de La Reunion-Site Number: 2500007
        • Investigador principal:
          • Antoine Bertolotti
        • Contato:
          • Antoine Bertolotti
    • Rhone
      • Romans-sur-Isère, Rhone, França, 26102
        • Recrutamento
        • Hopitaux Drome Nord-Site Number : 2500002
        • Investigador principal:
          • Francois Skowron
        • Contato:
    • Saone Et Loire
      • Chalon-sur-Saône, Saone Et Loire, França, 71100
        • Recrutamento
        • Centre Hospitalier William Morey-Site Number: 2500008
        • Contato:
        • Investigador principal:
          • Marie Dhers
    • Sarthe
      • Le Mans, Sarthe, França, 72037
        • Recrutamento
        • Centre Hospitalier du Mans-Site Number: 2500004
        • Contato:
        • Investigador principal:
          • Nathalie Beneton Benhard
  • Itália
      • Ancona, Itália, 60126
        • Recrutamento
        • Azienda Ospedaliero Universitaria delle Marche-Site Number: 3800009
        • Investigador principal:
          • Oriana Simonetti
        • Contato:
      • Novara, Itália, 28100
        • Recrutamento
        • Ospedale Maggiore di Novara-Site Number: 3800005
        • Contato:
        • Investigador principal:
          • Paola Savoia
      • Reggio Emilia, Itália, 42100
        • Recrutamento
        • Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia-Site Number : 3800006
        • Contato:
        • Investigador principal:
          • Vito Di Lernia
      • Roma, Itália, 00144
        • Recrutamento
        • Istituto San Gallicano IRCCS - Istituti Fisioterapici Ospitalieri-Site Number: 3800002
        • Contato:
        • Investigador principal:
          • Maria Concetta Fargnoli
  • Japão
    • Kagawa-ken
      • Marugame-shi, Kagawa-ken, Japão, 763-0074
        • Recrutamento
        • Takeoka Dermatology Clinic- Site Number : 3920005
        • Contato:
        • Investigador principal:
          • Shintaro Takeoka
    • Osaka
      • Habikino-shi, Osaka, Japão, 583-8588
        • Recrutamento
        • Osaka Habikino Medical Center-Site Number : 3920001
        • Investigador principal:
          • Yoko Kataoka
        • Contato:
    • Shizuoka
      • Hamamatsu, Shizuoka, Japão, 430-0929
        • Recrutamento
        • JA-Shizuoka Enshu Hospital-Site Number: 3920003
        • Contato:
        • Investigador principal:
          • Chika Shibuya

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

12 anos e mais velhos (Filho, Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

Patients with any atopic dermatitis severity will be invited to enroll in the registry after the decision has been made to initiate a new systemic medication for the first time or switch systemic therapies. Inclusion in the registry will not influence a patient's treatment course.

Descrição

Inclusion Criteria:

  • Patients aged more than or equal to (≥) 12 years at the time of consent.
  • Confirmed diagnosis of AD, of any severity, according to the Investigator's assessment as aligned with International Classification of Diseases 10th revision (ICD-10) code of L20.
  • Prescribed and scheduled to initiate any systemic treatment for AD (including but not limited to biologics, oral Janus kinase (JAK) inhibitors, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil)
  • Signed informed consent for registry participation by the patient or parent/legal representative and assent by the patient appropriate to the patient's age, including willingness to participate in long-term follow-up.

Exclusion Criteria:

  • Concurrent participation in an interventional clinical trial that administers an investigational drug that modifies patient care.
  • Insufficient understanding of the study by the patient and/or parent/guardian.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Modelos de observação: COHORT
  • Perspectivas de Tempo: PROSPECTIVE

Coortes e Intervenções

Grupo / Coorte
Atopic Dermatitis

This study plans to collect information on adolescent and adult patients with atopic dermatitis who initiate or switch any systemic treatment (eg, biologics, oral Janus kinase [JAK] inhibitors, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil) for AD according to the country-specific prescribing information. During the study, investigators will prescribe medical products for treatment of AD per standard of care (SoC) and per medical judgment.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of Participants Utilizing Atopic Dermatitis (AD) Treatment
Prazo: Baseline to up to 60 months

The number (and percentage) of participants taking AD treatments and treatments per patient will be described.
Baseline to up to 60 months
Duration of Treatment
Prazo: Baseline to up to 60 months

The duration of AD treatments will be summarized descriptively.
Baseline to up to 60 months
AD Treatment Sequences
Prazo: Baseline to up to 60 months

The ordering of AD treatments will be summarized descriptively.
Baseline to up to 60 months
Number of Participants Initiating AD Treatments with Reasons
Prazo: Baseline to up to 60 months

The number (and percentage) of patients initiating AD treatment and reasons for initiation will be summarized descriptively.
Baseline to up to 60 months
Number of Participants Interrupting AD Treatment
Prazo: Baseline to up to 60 months

The number (and percentage) of patients interrupting AD treatment and reasons for treatment interruption will be summarized descriptively.
Baseline to up to 60 months
Number of Participants Discontinuing AD Treatment
Prazo: Baseline to up to 60 months

The number (and percentage) of patients discontinuing AD treatment and reasons for treatment discontinuation will be summarized descriptively.
Baseline to up to 60 months
Number of Participants Switching AD Treatments
Prazo: Baseline to up to 60 months

The number (and percentage) of patients switching AD treatment and reasons for treatment switch will be summarized descriptively.
Baseline to up to 60 months
Number of Participants Augmenting AD treatment
Prazo: Baseline to up to 60 months

The number (and percentage) of patients augmenting AD treatment will be summarized descriptively.
Baseline to up to 60 months
Number of Participants Modifying AD Treatment Dose
Prazo: Baseline to up to 60 months

The number (and percentage) of patients modifying AD treatment dose, reasons for dose modification, and dosing will be summarized descriptively.
Baseline to up to 60 months
Change from Baseline in Extent and Severity of AD Measured with Eczema Area and Severity Index (EASI)
Prazo: Baseline to up to 60 months

Clinical outcomes measured using EASI will be summarized at the start of a treatment episode and each follow-up time point.
Baseline to up to 60 months
Change from Baseline in Extent and Severity of AD Measured with Body Surface Area (BSA)
Prazo: Baseline to up to 60 months

Clinical outcomes measured using BSA will be summarized at the start of a treatment episode and each follow-up time point.
Baseline to up to 60 months
Change from Baseline in Extent and Severity of AD Measured with Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD)
Prazo: Baseline to up to 60 months

Clinical outcomes measured using vIGA-AD will be summarized at the start of a treatment episode and each follow-up time point.
Baseline to up to 60 months
Change from Baseline in Extent and Severity of AD Measured with Revised Investigator's Global Assessment for Atopic Dermatitis (rIGA-AD)
Prazo: Baseline to up to 60 months

Clinical outcomes measured using rIGA-AD will be summarized at the start of a treatment episode and each follow-up time point.
Baseline to up to 60 months
Change in Atopic Dermatitis Control Test (ADCT) from Baseline
Prazo: Baseline to up to 60 months

The ADCT is a 6-item patient-reported outcomes instrument with a 7-day recall period to measure AD disease control. Total score ranges from 0 to 24.
Baseline to up to 60 months
Change in Patient Global Impression of Severity (PGIS) from Baseline
Prazo: Baseline to up to 60 months

The PGIS is a single item tool used to assess current severity of eczema symptoms, scored on a 5-point scale from 1 = no symptoms to 5 = very severe symptoms.
Baseline to up to 60 months
Change in Itch severity as Measured with the Peak Pruritus Numeric Rating Scale (PP-NRS) from Baseline
Prazo: Baseline to up to 60 months

The PP-NRS is a single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD during the past 24 hours, with 0 = no itch and 10 = worst itch imaginable.
Baseline to up to 60 months
Change in Skin Pain as Measured with Skin Pain Numeric Rating Scale (SP-NRS) from Baseline
Prazo: Baseline to up to 60 months

The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD during the past 24 hours, with 0 = no pain and 10 = worst possible pain imaginable.
Baseline to up to 60 months
Change in Sleep Disturbance as Measured with Sleep Disturbance Numeric Rating Scale (SD-NRS) from Baseline
Prazo: Baseline to up to 60 months

The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD, with 0 being 'no sleep loss related to the symptoms of atopic dermatitis' and 10 being 'I did not sleep at all' due to the symptoms of atopic dermatitis.
Baseline to up to 60 months
Remission of AD
Prazo: Baseline to up to 60 months

Total remission of all signs and symptoms of AD will be assessed.
Baseline to up to 60 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Sociodemographic characteristics of Participants
Prazo: Baseline

Demographics characteristics including age, sex, body weight, height, geographic region, education level, employment status, smoking and alcohol status will be collected.
Baseline
Ethnic Origin in Combination with Fitzpatrick Scale
Prazo: Baseline

The Fitzpatrick Skin Type Scale was developed based on an individual's reaction to sun exposure and will be completed by the Investigator. Skin types range from I - VI, with scores of I indicating the palest skin tone with no inherent melanin pigmentation, and VI indicating the darkest skin tone with significant amount of melanin.
Baseline
Disease characteristics of Participants
Prazo: Baseline

History of AD (including date of diagnosis, age of onset, specialty of provider who diagnosed condition), AD morphology, including but not limited to, patches, plaques, prurigo nodules, lichenoid papules, perifollicular papules, nummular lesions, and psoriasiform lesions and family history of AD and comorbidities will be collected.
Baseline
Change from Baseline in Dermatology-specific Quality of Life Measure with Dermatology Life Quality Index (DLQI)
Prazo: Baseline to up to 60 months

DLQI is calculated by summing the score of each question resulting in a maximum score of 30 and a minimum score of 0 (higher scores indicate quality of life is more impaired).
Baseline to up to 60 months
Change from Baseline in Dermatology-specific Quality of Life Measure with Children's Dermatology Life Quality Index (CDLQI)
Prazo: Baseline to up to 60 months

The CDLQI is calculated by summing the score of each question resulting in a maximum score of 30 and a minimum score of 0 (higher scores indicate quality of life is more impaired).
Baseline to up to 60 months
Change from Baseline in Burden of Assessment Using Patient Health Questionnaire-9 (PHQ-9)
Prazo: Baseline to up to 60 months

PHQ-9 is a 9-item, validated, patient-reported questionnaire to assess depression which scores each of the 9 Diagnostic and Statistical Manual of Mental Disorders-IV criteria as "0" (not at all) to "3" (nearly every day). Possible scores range from 0 to 27 and are classified as 1-4: "minimal depression"; 5-9: "mild depression"; 10-14: "moderate depression"; 15-19: "moderately severe depression"; and 20-27: "severe depression".
Baseline to up to 60 months
Change from Baseline in AD Specific Work and Classroom Productivity and Impairment Assessed Using WPAI+CIQ
Prazo: Baseline to up to 60 months

Work Productivity and Activity Impairment plus Classroom Impairment Questions (WPAI+CIQ) is a 10-item, patient-reported, validated questionnaire adapted for AD to measure impairments in work, classroom, and regular daily activities over a 7-day period.
Baseline to up to 60 months
Change from Baseline in Treatment Satisfaction Assessed Using Treatment Satisfaction Questionnaire for Medication (TSQM-9)
Prazo: Baseline to up to 60 months

The 14-item TSQM-9 is a generic measure of treatment satisfaction, assessing side effects, effectiveness, convenience and global satisfaction, over the last 2 to 3 weeks, or since the patient has last used it. A lower score indicates lower satisfaction with treatment.
Baseline to up to 60 months
Visits with Specialty of Attending Healthcare Provider and Reason for Visit
Prazo: Baseline to up to 60 months

Health care resource utilization including visits with specialty of attending health care provider and reason for visit (example, disease flare-up, regular visit, prescription change, adverse event [AE]) will be assessed.
Baseline to up to 60 months
Hospitalizations for AD
Prazo: Baseline to up to 60 months

Hospitalization for AD will be assessed.
Baseline to up to 60 months
Prevalence of Comorbid Atopic Conditions
Prazo: Baseline to up to 60 months

Prevalence of comorbid atopic conditions (including but not limited to, asthma, allergic conjunctivitis, allergic rhinitis, eosinophilic esophagitis, nasal polyposis, food allergy, prurigo nodularis, chronic spontaneous urticaria, and rhinoconjunctivitis) and non-atopic conditions (including but not limited to, insomnia, anxiety, attention deficit disorder, depression, major adverse cardiovascular event, cardiovascular disease, skin infection, pulmonary disease, osteoporosis, fractures, contact allergy, and inflammatory conditions) will be assessed.
Baseline to up to 60 months
Incidence of Comorbid Atopic Conditions
Prazo: Baseline to up to 60 months

Incidence of comorbid atopic conditions (including but not limited to, asthma, allergic conjunctivitis, allergic rhinitis, eosinophilic esophagitis, nasal polyposis, food allergy, prurigo nodularis, chronic spontaneous urticaria, and rhinoconjunctivitis) and non-atopic conditions (including but not limited to, insomnia, anxiety, attention deficit disorder, depression, major adverse cardiovascular event, cardiovascular disease, skin infection, pulmonary disease, osteoporosis, fractures, contact allergy, and inflammatory conditions) will be assessed.
Baseline to up to 60 months
Change from Baseline in Asthma Control Assessed with Asthma Control Questionnaire-5 (ACQ-5)
Prazo: Baseline to up to 60 months

ACQ-5 is a 5-item questionnaire used to assess asthma control [33]. Each question is rated on a 7-point scale (0=no impairment; 6=maximum impairment). The ACQ-5 score is calculated using the mean of the 5 items and ranges between 0 (well controlled asthma) to 6 (extremely poorly controlled asthma). The ACQ-5 will only be completed by patients with comorbid asthma.
Baseline to up to 60 months
Occurrence of Concomitant Medication use for AD and Selected Comorbidities
Prazo: Baseline to up to 60 months

The occurrence of concomitant medication use for AD and selected comorbidities at baseline and changes (including reason for change) will be summarized.
Baseline to up to 60 months
Number of Adverse Events (SAEs)
Prazo: Baseline to up to 60 months

Number of patients experiencing AEs.
Baseline to up to 60 months
Number of Serious Adverse Events (SAEs)
Prazo: Baseline to up to 60 months

Number of patients experiencing SAEs.
Baseline to up to 60 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Sanofi

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

17 de novembro de 2025

Conclusão Primária (Estimado)

30 de janeiro de 2034

Conclusão do estudo (Estimado)

30 de janeiro de 2034

Datas de inscrição no estudo

Enviado pela primeira vez

28 de novembro de 2025

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de dezembro de 2025

Primeira postagem (Real)

18 de dezembro de 2025

Atualizações de registro de estudo

Última Atualização Postada (Real)

2 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

30 de outubro de 2026

Última verificação

1 de outubro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • OBS18388
  • U1111-1311-1824 (Identificador de registro: ICTRP)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever