Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Cette étude est un registre de maladies non interventionnel de patients adolescents et adultes atteints de dermatite atopique qui initient ou changent tout traitement systémique (ARMADA-AD)

30 octobre 2026 mis à jour par: Sanofi

Registre de la Dermatite Atopique pour les Patients Adultes et Adolescents Débutant ou Changeant de Traitements Systémiques

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Type d'étude

Observationnel

Inscription (Estimé)

1000

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

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

Lieux d'étude

  • Arabie Saoudite
      • Jeddah, Arabie Saoudite, 21452
        • Recrutement
        • Erfan and Bagedo Hospital-Site Number : 6820002
        • Contact:
        • Chercheur principal:
          • Ahmed Ismail Ebraheem Abdellateef
      • Jeddah, Arabie Saoudite, 23421
        • Recrutement
        • Medical Fakeeh-Site Number : 6820003
        • Contact:
        • Chercheur principal:
          • Ayman Elgendi
      • Riyadh, Arabie Saoudite, 12231
        • Recrutement
        • King Fahad Medical City-Site Number : 6820001
        • Contact:
        • Chercheur principal:
          • Mohammed Alajlan
  • Canada
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4V 1R9
        • Recrutement
        • Origins Dermatology Centre-Site Number : 1240003
        • Chercheur principal:
          • Rachel Asiniwasis
        • Contact:
  • Chine
      • Chongqing, Chine, 400016
        • Recrutement
        • The First Affiliated Hospital of Chongqing Medical University-Site Number : 1560011
        • Contact:
        • Chercheur principal:
          • Tao Cai
      • Shanghai, Chine, 200040
        • Recrutement
        • Huashan Hospital, Fudan University-Site Number: 1560012
        • Chercheur principal:
          • Wei Li
        • Contact:
    • Beijing Municipality
      • Beijing, Beijing Municipality, Chine, 100191
        • Recrutement
        • Peking University Third Hospital-Site Number: 1560008
        • Chercheur principal:
          • Wenhui Wang
        • Contact:
          • Wenhui Wang
          • Numéro de téléphone: +8618618269437
          • E-mail: wwh0608@126.com
    • Guangdong
      • Shenzhen, Guangdong, Chine, 518033
        • Recrutement
        • The Eighth Affiliated Hospital, Sun Yat-sen University-Site Number: 1560006
        • Contact:
          • Peimei Zhou
          • Numéro de téléphone: +8613880699378
          • E-mail: 46551704@qq.com
        • Chercheur principal:
          • Peimei Zhou
    • Hu'nan
      • Changsha, Hu'nan, Chine, 410008
        • Recrutement
        • Xiangya Hospital of Central South University-Site Number : 1560001
        • Chercheur principal:
          • Juan Su
        • Contact:
      • Changsha, Hu'nan, Chine, 410011
        • Recrutement
        • The Second Xiangya Hospital of Central South University-Site Number: 1560014
        • Chercheur principal:
          • Yunsheng Liang
        • Contact:
    • Shanxi
      • Xi’an, Shanxi, Chine, 710004
        • Recrutement
        • The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)-Site Number: 1560002
        • Chercheur principal:
          • Songmei Geng
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, Chine, 610041
        • Recrutement
        • West China Hospital, Sichuan University- Site Number: 1560003
        • Chercheur principal:
          • Jingyi Li
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, Chine, 310006
        • Recrutement
        • Hangzhou First People's Hospital-Site Number: 1560004
        • Chercheur principal:
          • Liming Wu
        • Contact:
      • Hangzhou, Zhejiang, Chine, 310009
        • Recrutement
        • The Second Affiliated Hospital of Zhejiang University School of Medicine-Site Number: 1560007
        • Chercheur principal:
          • Xiaoyong Man
        • Contact:
      • Ningbo, Zhejiang, Chine, 315010
        • Recrutement
        • The First Affiliated Hospital of Ningbo University-Site Number : 1560009
        • Contact:
        • Chercheur principal:
          • Bingjiang Lin
  • Emirats Arabes Unis
      • Abu Dhabi, Emirats Arabes Unis, 66566
        • Recrutement
        • Mediclinic Hospital, AUH-Site Number: 7840004
        • Contact:
        • Chercheur principal:
          • Hussein Abdel Dayem
      • Abu Dhabi, Emirats Arabes Unis, 6222
        • Recrutement
        • NMC Specialty Hospital-Site Number : 7840002
        • Contact:
        • Chercheur principal:
          • Ahmed Ameen
      • Al Karama, Emirats Arabes Unis, 50730
        • Recrutement
        • Dr Joseph Polyclinic Amber Clinic-Site Number: 7840005
        • Contact:
        • Chercheur principal:
          • Srikumar Goturu
      • Dubai, Emirats Arabes Unis, 00000
        • Recrutement
        • Dermatology and Aesthetic Center Rashid Hospital-Site Number : 7840003
        • Contact:
        • Chercheur principal:
          • Amani Abdulla Rahma Alfalasi
  • Espagne
      • Alicante, Espagne, 03010
        • Recrutement
        • Hospital General Universitario Dr. Balmis-Site Number: 7240005
        • Chercheur principal:
          • Juan Francisco Silvestre Salvador
        • Contact:
    • Catalunya [Cataluña]
      • Barcelona, Catalunya [Cataluña], Espagne, 08041
        • Recrutement
        • Investigational Site Number : 7240006
    • Tenerife
      • Santa Cruz de Tenerife, Tenerife, Espagne, 38320
        • Recrutement
        • Hospital Universitario de Canarias-Site Number: 7240008
        • Chercheur principal:
          • Ruperto Gonzalez Perez
        • Contact:
  • France
    • Doubs
      • Besançon, Doubs, France, 25030
        • Recrutement
        • CHU Besançon - Hôpital Jean Minjoz-Site Number: 2500010
        • Chercheur principal:
          • Francois Aubin
        • Contact:
    • Drome
      • Valence, Drome, France, 26000
        • Recrutement
        • Centre Hospitalier de Valence-Site Number: 2500005
        • Contact:
        • Chercheur principal:
          • Anne Grange
    • Haut Rhin
      • Mulhouse, Haut Rhin, France, 68100
        • Recrutement
        • GHRMSA - Hospital Emile Muller-Site Number : 2500006
        • Contact:
        • Chercheur principal:
          • Catherine Michel
    • Reunion
      • Saint-Pierre, Reunion, France, 97448
        • Recrutement
        • CHU de La Reunion-Site Number: 2500007
        • Chercheur principal:
          • Antoine Bertolotti
        • Contact:
          • Antoine Bertolotti
    • Rhone
      • Romans-sur-Isère, Rhone, France, 26102
        • Recrutement
        • Hopitaux Drome Nord-Site Number : 2500002
        • Chercheur principal:
          • Francois Skowron
        • Contact:
    • Saone Et Loire
      • Chalon-sur-Saône, Saone Et Loire, France, 71100
        • Recrutement
        • Centre Hospitalier William Morey-Site Number: 2500008
        • Contact:
        • Chercheur principal:
          • Marie Dhers
    • Sarthe
      • Le Mans, Sarthe, France, 72037
        • Recrutement
        • Centre Hospitalier du Mans-Site Number: 2500004
        • Contact:
        • Chercheur principal:
          • Nathalie Beneton Benhard
  • Italie
      • Ancona, Italie, 60126
        • Recrutement
        • Azienda Ospedaliero Universitaria delle Marche-Site Number: 3800009
        • Chercheur principal:
          • Oriana Simonetti
        • Contact:
      • Novara, Italie, 28100
        • Recrutement
        • Ospedale Maggiore di Novara-Site Number: 3800005
        • Contact:
        • Chercheur principal:
          • Paola Savoia
      • Reggio Emilia, Italie, 42100
        • Recrutement
        • Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia-Site Number : 3800006
        • Contact:
        • Chercheur principal:
          • Vito Di Lernia
      • Roma, Italie, 00144
        • Recrutement
        • Istituto San Gallicano IRCCS - Istituti Fisioterapici Ospitalieri-Site Number: 3800002
        • Contact:
        • Chercheur principal:
          • Maria Concetta Fargnoli
  • Japon
    • Kagawa-ken
      • Marugame-shi, Kagawa-ken, Japon, 763-0074
        • Recrutement
        • Takeoka Dermatology Clinic- Site Number : 3920005
        • Contact:
        • Chercheur principal:
          • Shintaro Takeoka
    • Osaka
      • Habikino-shi, Osaka, Japon, 583-8588
        • Recrutement
        • Osaka Habikino Medical Center-Site Number : 3920001
        • Chercheur principal:
          • Yoko Kataoka
        • Contact:
    • Shizuoka
      • Hamamatsu, Shizuoka, Japon, 430-0929
        • Recrutement
        • JA-Shizuoka Enshu Hospital-Site Number: 3920003
        • Contact:
        • Chercheur principal:
          • Chika Shibuya
  • États-Unis
    • Alabama
      • Birmingham, Alabama, États-Unis, 35244
        • Recrutement
        • Cahaba Dermatology & Skin Health Center- Site Number : 8400006
        • Chercheur principal:
          • Vlada Groysman
        • Contact:
      • Montgomery, Alabama, États-Unis, 36117
        • Recrutement
        • River Region Dermatology and Laser- Site Number : 8400041
        • Chercheur principal:
          • Porcia Love
        • Contact:
    • Arizona
      • Gilbert, Arizona, États-Unis, 85234
        • Recrutement
        • San Tan Allergy & Asthma- Site Number : 8400031
        • Contact:
        • Chercheur principal:
          • Sam Reed Shimamoto
      • Phoenix, Arizona, États-Unis, 85008
        • Recrutement
        • Saguaro Dermatology- Site Number : 8400028
        • Chercheur principal:
          • Dathan Hamann
        • Contact:
    • California
      • Bakersfield, California, États-Unis, 93301
        • Recrutement
        • Kern Research, Inc.- Site Number : 8400047
        • Chercheur principal:
          • Tonny Tanus
        • Contact:
      • Fremont, California, États-Unis, 94538
        • Recrutement
        • Center for Dermatology Clinical Research- Site Number : 8400014
        • Chercheur principal:
          • Sunil Dhawan
        • Contact:
          • Sunil Dhawan
          • Numéro de téléphone: 510-797-4111
          • E-mail: sdhaw@yahoo.com
      • Los Angeles, California, États-Unis, 90045
        • Recrutement
        • Dermatology Research Associates - Los Angeles- Site Number : 8400020
        • Chercheur principal:
          • Howard Sofen
        • Contact:
          • Howard Sofen
          • Numéro de téléphone: 310-337-7171
          • E-mail: hsofen@ucla.edu
      • Northridge, California, États-Unis, 91325
        • Recrutement
        • Northridge Clinical Trials, LLC- Site Number : 8400009
        • Chercheur principal:
          • Navid Ezra
        • Contact:
      • Oakland, California, États-Unis, 94596
        • Recrutement
        • Sunwise Clinical Research, LLC.- Site Number : 8400010
        • Contact:
          • Michael Abdel Malek
          • Numéro de téléphone: 9252985147
          • E-mail: mike@sunclin.com
        • Chercheur principal:
          • Michael Abdel Malek
      • Pomona, California, États-Unis, 91767
        • Recrutement
        • Empire Clinical Research, LLC- Site Number : 8400007
        • Contact:
          • Usha Mantha
        • Chercheur principal:
          • Usha Mantha
      • San Diego, California, États-Unis, 92123
        • Recrutement
        • University Clinical Trials- Site Number : 8400019
        • Chercheur principal:
          • Walter Nahm
        • Contact:
    • Colorado
      • Wheat Ridge, Colorado, États-Unis, 80033
        • Recrutement
        • Western States Clinical Research, Inc.- Site Number : 8400051
        • Chercheur principal:
          • Jeffrey Rumbyrt
        • Contact:
    • Florida
      • Doral, Florida, États-Unis, 33172
        • Recrutement
        • St. Jude Clinical Research- Site Number : 8400049
        • Contact:
        • Chercheur principal:
          • Gustavo Torres
      • North Miami Beach, Florida, États-Unis, 33162-4708
        • Recrutement
        • Ziaderm Research, LLC- Site Number : 8400021
        • Chercheur principal:
          • Tory Sullivan
        • Contact:
    • Georgia
      • Macon, Georgia, États-Unis, 31217
        • Recrutement
        • Skin Care Physicians of Georgia - Macon- Site Number : 8400034
        • Chercheur principal:
          • David Cohen
        • Contact:
    • Illinois
      • Normal, Illinois, États-Unis, 61761
        • Recrutement
        • Sneeze, Wheeze, & Itch Associates, LLC- Site Number : 8400029
        • Chercheur principal:
          • Dareen Siri
        • Contact:
      • North Chicago, Illinois, États-Unis, 60064
        • Recrutement
        • Rosalind Franklin University of Medicine and Science- Site Number: 8400056
        • Chercheur principal:
          • Raj Chovatiya
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, États-Unis, 48103
        • Recrutement
        • David Fivenson, MD, Dermatology, PLLC- Site Number : 8400017
        • Chercheur principal:
          • David Fivenson
        • Contact:
      • Auburn Hills, Michigan, États-Unis, 48326
        • Recrutement
        • Oakland Hills Dermatology- Site Number : 8400042
        • Chercheur principal:
          • Christofer Buatti
        • Contact:
      • Bay City, Michigan, États-Unis, 48706
        • Recrutement
        • Great Lakes Research Group - Bay City- Site Number : 8400052
        • Chercheur principal:
          • Brent Boyce
        • Contact:
      • Caledonia, Michigan, États-Unis, 49316
        • Recrutement
        • The Derm Institute of West Michigan- Site Number : 8400025
        • Chercheur principal:
          • Kristi Hawley
        • Contact:
        • Contact:
      • Detroit, Michigan, États-Unis, 48201
        • Recrutement
        • Wayne State University - Detroit Medical Center- Site Number : 8400035
        • Chercheur principal:
          • Steven Daveluy
        • Contact:
      • Waterford, Michigan, États-Unis, 48328
        • Recrutement
        • Michigan Dermatology Institute - Waterford- Site Number : 8400013
        • Contact:
        • Chercheur principal:
          • Cory Rubin
    • Missouri
      • Bolivar, Missouri, États-Unis, 65613
        • Recrutement
        • Red River Research Partners, Llc- Site Number : 8400054
        • Contact:
        • Chercheur principal:
          • Murphy Mastin
      • Kirksville, Missouri, États-Unis, 63501
        • Recrutement
        • Cleaver Dermatology- Site Number : 8400033
        • Contact:
        • Chercheur principal:
          • David Cleaver
    • Nebraska
      • Lincoln, Nebraska, États-Unis, 68510
        • Recrutement
        • Allergy Asthma & Immunology- Site Number : 8400044
        • Chercheur principal:
          • Robert Szalewski
        • Contact:
    • Nevada
      • Las Vegas, Nevada, États-Unis, 89144
        • Recrutement
        • Las Vegas Dermatology- Site Number : 8400002
        • Chercheur principal:
          • Harry Greenberg
        • Contact:
    • New Hampshire
      • Portsmouth, New Hampshire, États-Unis, 03801
        • Recrutement
        • Optima Research Portsmouth- Site Number : 8400032
        • Chercheur principal:
          • Abel Jarell
        • Contact:
    • New Mexico
      • Albuquerque, New Mexico, États-Unis, 87106
        • Recrutement
        • University Of New Mexico School Of Medicine- Site Number : 8400022
    • North Carolina
      • Huntersville, North Carolina, États-Unis, 28078
        • Recrutement
        • Piedmont Plastic Surgery and Dermatology- Site Number : 8400038
        • Contact:
        • Chercheur principal:
          • Nicole Seminara Zambrzycka
      • Winston-Salem, North Carolina, États-Unis, 27104
        • Recrutement
        • Wake Forest University Health Sciences- Site Number : 8400003
        • Chercheur principal:
          • Steven Feldman
        • Contact:
    • North Dakota
      • Fargo, North Dakota, États-Unis, 58103
        • Recrutement
        • Red River Research Partners - Fargo- Site Number : 8400037
        • Chercheur principal:
          • Michael Blankinship
        • Contact:
    • Ohio
      • Marion, Ohio, États-Unis, 43302
        • Recrutement
        • Dermatology Associates of Mid-Ohio- Site Number : 8400026
        • Contact:
          • George Scott Drew
          • Numéro de téléphone: 740-244-8559
          • E-mail: spfxv@aol.com
        • Chercheur principal:
          • George Scott Drew
      • Mason, Ohio, États-Unis, 45040
        • Recrutement
        • Dermatologists of Southwest Ohio - Mason- Site Number : 8400050
        • Chercheur principal:
          • Rocco Serrao
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, États-Unis, 15213
        • Recrutement
        • UPMC - Department of Dermatology- Site Number : 8400024
        • Chercheur principal:
          • Joe Tung
        • Contact:
    • Rhode Island
      • Warwick, Rhode Island, États-Unis, 02886
        • Recrutement
        • Care Access Research - Warwick 2- Site Number : 8400045
        • Contact:
        • Chercheur principal:
          • John Zwetchkenbaum
    • South Carolina
      • Spartanburg, South Carolina, États-Unis, 29307
        • Recrutement
        • Advanced Dermatology and Cosmetic Surgery - Spartanburg- Site Number : 8400004
        • Contact:
        • Chercheur principal:
          • Amylynne Frankel
    • Texas
      • Dallas, Texas, États-Unis, 75235
        • Recrutement
        • Reveal Research Institute - Dallas- Site Number : 8400012
        • Chercheur principal:
          • Aaron Farberg
        • Contact:
      • Fort Worth, Texas, États-Unis, 76244
        • Complété
        • Innovate Research - Fort Worth- Site Number : 8400016
      • Pflugerville, Texas, États-Unis, 78660
        • Recrutement
        • Austin Institute for Clinical Research, Inc- Site Number : 8400030
        • Chercheur principal:
          • Edward Lain
        • Contact:
      • Sugar Land, Texas, États-Unis, 77479
        • Recrutement
        • Complete Dermatology - Sugar Land- Site Number : 8400001
        • Chercheur principal:
          • Bartley Gill
        • Contact:
    • Utah
      • Bountiful, Utah, États-Unis, 84010
        • Recrutement
        • Cope Family Medicine - Ogden Clinic- Site Number : 8400053
      • Springville, Utah, États-Unis, 84663
        • Recrutement
        • Springville Dermatology - Springville- Site Number : 8400055
        • Contact:
        • Chercheur principal:
          • Michael Peterson
    • Virginia
      • Falls Church, Virginia, États-Unis, 22042
        • Recrutement
        • Fuchs Dermatology- Site Number : 8400027
        • Contact:
        • Chercheur principal:
          • Aaron Fuchs
    • Washington
      • Mill Creek, Washington, États-Unis, 98012
        • Recrutement
        • Frontier Dermatology Partners CRO LLC- Site Number : 8400011
        • Contact:
        • Chercheur principal:
          • Eingun James Song
      • Seattle, Washington, États-Unis, 98105
        • Recrutement
        • University of Washington - Roosevelt Location- Site Number : 8400005
        • Contact:
        • Chercheur principal:
          • Vivian Shi

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

12 ans et plus (Enfant, Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: COHORT
  • Perspectives temporelles: PROSPECTIVE

Cohortes et interventions

Groupe / Cohorte
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of Participants Utilizing Atopic Dermatitis (AD) Treatment
Délai: 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
Délai: Baseline to up to 60 months

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

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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Sociodemographic characteristics of Participants
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: Baseline to up to 60 months

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

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

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Sanofi

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

17 novembre 2025

Achèvement primaire (Estimé)

30 janvier 2034

Achèvement de l'étude (Estimé)

30 janvier 2034

Dates d'inscription aux études

Première soumission

28 novembre 2025

Première soumission répondant aux critères de contrôle qualité

17 décembre 2025

Première publication (Réel)

18 décembre 2025

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 octobre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • OBS18388
  • U1111-1311-1824 (Identificateur de registre: ICTRP)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime 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

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner