This Study is a Non-interventional Disease Registry of Adolescent and Adult Patients With Atopic Dermatitis Who Initiate or Switch Any Systemic Treatment (ARMADA-AD)

May 29, 2026 updated by: Sanofi

Atopic Dermatitis Disease Registry of Adult and Adolescent Patients Initiating or Switching Systemic Treatments

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial Transparency email recommended (Toll free for US & Canada)
  • Phone Number: option 6 800-633-1610
  • Email: contact-us@sanofi.com

Study Locations

  • Canada
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4V 1R9
        • Recruiting
        • Origins Dermatology Centre-Site Number : 1240003
        • Principal Investigator:
          • Rachel Asiniwasis
        • Contact:
  • China
      • Chongqing, China, 400016
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University-Site Number : 1560011
        • Contact:
        • Principal Investigator:
          • Tao Cai
      • Shanghai, China, 200040
        • Recruiting
        • Huashan Hospital, Fudan University-Site Number: 1560012
        • Principal Investigator:
          • Wei Li
        • Contact:
    • Shanxi
      • Xi’an, Shanxi, China, 710004
        • Recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)-Site Number: 1560002
        • Principal Investigator:
          • Songmei Geng
        • Contact:
    • Zhejiang
      • Ningbo, Zhejiang, China, 315010
        • Recruiting
        • The First Affiliated Hospital of Ningbo University-Site Number : 1560009
        • Contact:
        • Principal Investigator:
          • Bingjiang Lin
  • France
    • Drome
      • Valence, Drome, France, 26000
        • Recruiting
        • Centre Hospitalier de Valence-Site Number: 2500005
        • Contact:
        • Principal Investigator:
          • Anne Grange
    • Haut Rhin
      • Mulhouse, Haut Rhin, France, 68100
        • Recruiting
        • GHRMSA - Hospital Emile Muller-Site Number : 2500006
        • Contact:
        • Principal Investigator:
          • Catherine Michel
  • Italy
      • Ancona, Italy, 60126
        • Recruiting
        • Azienda Ospedaliero Universitaria delle Marche-Site Number: 3800009
        • Principal Investigator:
          • Oriana Simonetti
        • Contact:
      • Novara, Italy, 28100
        • Recruiting
        • Ospedale Maggiore di Novara-Site Number: 3800005
        • Contact:
        • Principal Investigator:
          • Paola Savoia
      • Reggio Emilia, Italy, 42100
        • Recruiting
        • Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia-Site Number : 3800006
        • Contact:
        • Principal Investigator:
          • Vito Di Lernia
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 12231
        • Recruiting
        • King Fahad Medical City-Site Number : 6820001
        • Contact:
        • Principal Investigator:
          • Mohammed Alajlan
      • Riyadh, Saudi Arabia, 11472
        • Recruiting
        • King Saud University-Site Number: 6820004
        • Contact:
        • Principal Investigator:
          • Mohammed Al-Haddab
  • United Arab Emirates
      • Al Karama, United Arab Emirates, 50730
        • Recruiting
        • Dr Joseph Polyclinic Amber Clinic-Site Number: 7840005
        • Contact:
        • Principal Investigator:
          • Srikumar Goturu
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35244
        • Recruiting
        • Cahaba Dermatology & Skin Health Center- Site Number : 8400006
        • Principal Investigator:
          • Vlada Groysman
        • Contact:
      • Montgomery, Alabama, United States, 36117
        • Recruiting
        • River Region Dermatology and Laser- Site Number : 8400041
        • Principal Investigator:
          • Porcia Love
        • Contact:
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Recruiting
        • San Tan Allergy & Asthma- Site Number : 8400031
        • Contact:
        • Principal Investigator:
          • Sam Reed Shimamoto
    • California
      • Bakersfield, California, United States, 93301
        • Recruiting
        • Kern Research, Inc.- Site Number : 8400047
        • Principal Investigator:
          • Tonny Tanus
        • Contact:
      • Fremont, California, United States, 94538
        • Recruiting
        • Center for Dermatology Clinical Research- Site Number : 8400014
        • Principal Investigator:
          • Sunil Dhawan
        • Contact:
      • Los Angeles, California, United States, 90045
        • Recruiting
        • Dermatology Research Associates - Los Angeles- Site Number : 8400020
        • Principal Investigator:
          • Howard Sofen
        • Contact:
      • Northridge, California, United States, 91325
        • Recruiting
        • Northridge Clinical Trials, LLC- Site Number : 8400009
        • Principal Investigator:
          • Navid Ezra
        • Contact:
      • Oakland, California, United States, 94596
        • Recruiting
        • Sunwise Clinical Research, LLC.- Site Number : 8400010
        • Contact:
        • Principal Investigator:
          • Michael Abdel Malek
      • Pomona, California, United States, 91767
        • Recruiting
        • Empire Clinical Research, LLC- Site Number : 8400007
        • Principal Investigator:
          • Radhika Shah
        • Contact:
      • San Diego, California, United States, 92123
        • Recruiting
        • University Clinical Trials- Site Number : 8400019
    • Colorado
      • Wheat Ridge, Colorado, United States, 80033
        • Recruiting
        • Western States Clinical Research, Inc.- Site Number : 8400051
        • Principal Investigator:
          • Jeffrey Rumbyrt
        • Contact:
    • Florida
      • Doral, Florida, United States, 33172
        • Recruiting
        • St. Jude Clinical Research- Site Number : 8400049
        • Contact:
        • Principal Investigator:
          • Gustavo Torres
      • North Miami Beach, Florida, United States, 33162-4708
        • Recruiting
        • Ziaderm Research, LLC- Site Number : 8400021
        • Principal Investigator:
          • Tory Sullivan
        • Contact:
    • Georgia
      • Macon, Georgia, United States, 31217
        • Recruiting
        • Skin Care Physicians of Georgia - Macon- Site Number : 8400034
        • Principal Investigator:
          • David Cohen
        • Contact:
    • Illinois
      • Normal, Illinois, United States, 61761
        • Recruiting
        • Sneeze, Wheeze, & Itch Associates, LLC- Site Number : 8400029
        • Principal Investigator:
          • Dareen Siri
        • Contact:
      • North Chicago, Illinois, United States, 60064
        • Recruiting
        • Rosalind Franklin University of Medicine and Science- Site Number: 8400056
        • Principal Investigator:
          • Raj Chovatiya
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48103
        • Recruiting
        • David Fivenson, MD, Dermatology, PLLC- Site Number : 8400017
        • Principal Investigator:
          • David Fivenson
        • Contact:
      • Auburn Hills, Michigan, United States, 48326
        • Recruiting
        • Oakland Hills Dermatology- Site Number : 8400042
        • Principal Investigator:
          • Christofer Buatti
        • Contact:
      • Bay City, Michigan, United States, 48706
        • Recruiting
        • Great Lakes Research Group - Bay City- Site Number : 8400052
        • Principal Investigator:
          • Brent Boyce
        • Contact:
      • Caledonia, Michigan, United States, 49316
        • Recruiting
        • The Derm Institute of West Michigan- Site Number : 8400025
        • Principal Investigator:
          • Kristi Hawley
        • Contact:
        • Contact:
      • Waterford, Michigan, United States, 48328
    • Missouri
      • Bolivar, Missouri, United States, 65613
        • Recruiting
        • Red River Research Partners, Llc- Site Number : 8400054
        • Contact:
        • Principal Investigator:
          • Murphy Mastin
      • Kirksville, Missouri, United States, 63501
        • Recruiting
        • Cleaver Dermatology- Site Number : 8400033
        • Contact:
        • Principal Investigator:
          • David Cleaver
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Recruiting
        • Allergy Asthma & Immunology- Site Number : 8400044
        • Principal Investigator:
          • Robert Szalewski
        • Contact:
    • Nevada
      • Las Vegas, Nevada, United States, 89144
        • Recruiting
        • Las Vegas Dermatology- Site Number : 8400002
        • Principal Investigator:
          • Harry Greenberg
        • Contact:
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Recruiting
        • Optima Research Portsmouth- Site Number : 8400032
        • Principal Investigator:
          • Abel Jarell
        • Contact:
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Recruiting
        • University Of New Mexico School Of Medicine- Site Number : 8400022
        • Contact:
        • Principal Investigator:
          • John Durkin
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Recruiting
        • Piedmont Plastic Surgery and Dermatology- Site Number : 8400038
        • Contact:
        • Principal Investigator:
          • Nicole Seminara Zambrzycka
      • Winston-Salem, North Carolina, United States, 27104
        • Recruiting
        • Wake Forest University Health Sciences- Site Number : 8400003
        • Principal Investigator:
          • Steven Feldman
        • Contact:
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Recruiting
        • Red River Research Partners - Fargo- Site Number : 8400037
        • Principal Investigator:
          • Michael Blankinship
        • Contact:
    • Ohio
      • Mason, Ohio, United States, 45040
        • Recruiting
        • Dermatologists of Southwest Ohio - Mason- Site Number : 8400050
        • Principal Investigator:
          • Rocco Serrao
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • UPMC - Department of Dermatology- Site Number : 8400024
        • Principal Investigator:
          • Joe Tung
        • Contact:
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Recruiting
        • Care Access Research - Warwick 2- Site Number : 8400045
        • Contact:
        • Principal Investigator:
          • John Zwetchkenbaum
    • South Carolina
      • Spartanburg, South Carolina, United States, 29307
        • Recruiting
        • Advanced Dermatology and Cosmetic Surgery - Spartanburg- Site Number : 8400004
        • Contact:
        • Principal Investigator:
          • Amylynne Frankel
    • Texas
      • Dallas, Texas, United States, 75235
        • Recruiting
        • Reveal Research Institute - Dallas- Site Number : 8400012
        • Principal Investigator:
          • Aaron Farberg
        • Contact:
      • Fort Worth, Texas, United States, 76244
        • Recruiting
        • Innovate Research - Fort Worth- Site Number : 8400016
        • Contact:
        • Principal Investigator:
          • Swapnil Vaidya
      • Pflugerville, Texas, United States, 78660
        • Recruiting
        • Austin Institute for Clinical Research, Inc- Site Number : 8400030
        • Principal Investigator:
          • Edward Lain
        • Contact:
      • Sugar Land, Texas, United States, 77479
        • Recruiting
        • Complete Dermatology - Sugar Land- Site Number : 8400001
        • Principal Investigator:
          • Bartley Gill
        • Contact:
    • Utah
      • Bountiful, Utah, United States, 84010-8917
        • Recruiting
        • Cope Family Medicine-Site Number : 8400053
      • Springville, Utah, United States, 84663
        • Recruiting
        • Springville Dermatology - Springville- Site Number : 8400055
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Recruiting
        • Fuchs Dermatology- Site Number : 8400027
        • Contact:
        • Principal Investigator:
          • Aaron Fuchs
    • Washington
      • Mill Creek, Washington, United States, 98012
        • Recruiting
        • Frontier Dermatology Partners CRO LLC- Site Number : 8400011
        • Contact:
        • Principal Investigator:
          • Eingun James Song
      • Seattle, Washington, United States, 98105
        • Recruiting
        • University of Washington - Roosevelt Location- Site Number : 8400005
        • Contact:
        • Principal Investigator:
          • Vivian Shi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Utilizing Atopic Dermatitis (AD) Treatment
Time Frame: 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
Time Frame: Baseline to up to 60 months
The duration of AD treatments will be summarized descriptively.
Baseline to up to 60 months
AD Treatment Sequences
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Baseline to up to 60 months
Total remission of all signs and symptoms of AD will be assessed.
Baseline to up to 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sociodemographic characteristics of Participants
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: Baseline to up to 60 months
Hospitalization for AD will be assessed.
Baseline to up to 60 months
Prevalence of Comorbid Atopic Conditions
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: Baseline to up to 60 months
Number of patients experiencing AEs.
Baseline to up to 60 months
Number of Serious Adverse Events (SAEs)
Time Frame: Baseline to up to 60 months
Number of patients experiencing SAEs.
Baseline to up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2025

Primary Completion (Estimated)

January 30, 2034

Study Completion (Estimated)

January 30, 2034

Study Registration Dates

First Submitted

November 28, 2025

First Submitted That Met QC Criteria

December 17, 2025

First Posted (Actual)

December 18, 2025

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBS18388
  • U1111-1311-1824 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atopic Dermatitis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe