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Deze studie is een niet-interventioneel ziekteregister van adolescente en volwassen patiënten met constitutioneel eczeem die een systemische behandeling starten of overstappen (ARMADA-AD)

30 oktober 2026 bijgewerkt door: Sanofi

Atopisch Eczeem Ziekteregister voor Volwassen en Adolescenten Patiënten die Systemische Behandelingen Starten of Wisselen

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.

Studie Overzicht

Toestand

Werving

Conditie

Studietype

Observationeel

Inschrijving (Geschat)

1000

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

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

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

12 jaar en ouder (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: COHORT
  • Tijdsperspectieven: PROSPECTIVE

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants Utilizing Atopic Dermatitis (AD) Treatment
Tijdsspanne: 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
Tijdsspanne: Baseline to up to 60 months

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

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Sociodemographic characteristics of Participants
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline to up to 60 months

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

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

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

Medewerkers en onderzoekers

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Sponsor

Sanofi

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

17 november 2025

Primaire voltooiing (Geschat)

30 januari 2034

Studie voltooiing (Geschat)

30 januari 2034

Studieregistratiedata

Eerst ingediend

28 november 2025

Eerst ingediend dat voldeed aan de QC-criteria

17 december 2025

Eerst geplaatst (Werkelijk)

18 december 2025

Updates van studierecords

Laatste update geplaatst (Werkelijk)

2 november 2026

Laatste update ingediend die voldeed aan QC-criteria

30 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • OBS18388
  • U1111-1311-1824 (Register-ID: ICTRP)

Plan Individuele Deelnemersgegevens (IPD)

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JA

Beschrijving IPD-plan

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

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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