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

NCT07290803 | Recruiting

• 2 other identifiers: OBS18388U1111-1311-1824
• Study Type: observational
• Target: 1,000
• Locations: 6 countries
• Sites: 43

Brief Summary

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (19)

• Number of Participants Utilizing Atopic Dermatitis (AD) Treatment

  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

  The duration of AD treatments will be summarized descriptively.

  Baseline to up to 60 months

• AD Treatment Sequences

  The ordering of AD treatments will be summarized descriptively.

  Baseline to up to 60 months

• Number of Participants Initiating AD Treatments with Reasons

  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

  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

  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

  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

  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

  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)

  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)

  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)

  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)

  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

  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

  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

  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

  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

  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

  Total remission of all signs and symptoms of AD will be assessed.

  Baseline to up to 60 months

Secondary Outcomes (16)

• Sociodemographic characteristics of Participants

  Baseline

• Ethnic Origin in Combination with Fitzpatrick Scale

  Baseline

• Disease characteristics of Participants

  Baseline

• Change from Baseline in Dermatology-specific Quality of Life Measure with Dermatology Life Quality Index (DLQI)

  Baseline to up to 60 months

• Change from Baseline in Dermatology-specific Quality of Life Measure with Children's Dermatology Life Quality Index (CDLQI)

  Baseline to up to 60 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (43)

Cahaba Dermatology & Skin Health Center- Site Number : 8400006

Birmingham, Alabama, 35244, United States

RECRUITING

River Region Dermatology and Laser- Site Number : 8400041

Montgomery, Alabama, 36117, United States

RECRUITING

San Tan Allergy & Asthma- Site Number : 8400031

Gilbert, Arizona, 85234, United States

RECRUITING

Kern Research, Inc.- Site Number : 8400047

Bakersfield, California, 93301, United States

RECRUITING

Center for Dermatology Clinical Research- Site Number : 8400014

Fremont, California, 94538, United States

RECRUITING

Dermatology Research Associates - Los Angeles- Site Number : 8400020

Los Angeles, California, 90045, United States

RECRUITING

Northridge Clinical Trials, LLC- Site Number : 8400009

Northridge, California, 91325, United States

RECRUITING

Sunwise Clinical Research, LLC.- Site Number : 8400010

Oakland, California, 94596, United States

RECRUITING

Empire Clinical Research, LLC- Site Number : 8400007

Pomona, California, 91767, United States

RECRUITING

University Clinical Trials- Site Number : 8400019

San Diego, California, 92123, United States

RECRUITING

Western States Clinical Research, Inc.- Site Number : 8400051

Wheat Ridge, Colorado, 80033, United States

RECRUITING

St. Jude Clinical Research- Site Number : 8400049

Doral, Florida, 33172, United States

RECRUITING

Ziaderm Research, LLC- Site Number : 8400021

North Miami Beach, Florida, 33162-4708, United States

RECRUITING

Skin Care Physicians of Georgia - Macon- Site Number : 8400034

Macon, Georgia, 31217, United States

RECRUITING

Georgia Skin & Cancer Clinic- Site Number : 8400023

Savannah, Georgia, 31419, United States

RECRUITING

Rosalind Franklin University of Medicine and Science- Site Number: 8400056

North Chicago, Illinois, 60064, United States

RECRUITING

David Fivenson, MD, Dermatology, PLLC- Site Number : 8400017

Ann Arbor, Michigan, 48103, United States

RECRUITING

Oakland Hills Dermatology- Site Number : 8400042

Auburn Hills, Michigan, 48326, United States

RECRUITING

Great Lakes Research Group - Bay City- Site Number : 8400052

Bay City, Michigan, 48706, United States

RECRUITING

The Derm Institute of West Michigan- Site Number : 8400025

Caledonia, Michigan, 49316, United States

RECRUITING

Michigan Dermatology Institute - Waterford- Site Number : 8400013

Waterford, Michigan, 48328, United States

RECRUITING

Red River Research Partners, LLC- Site Number : 8400054

Bolivar, Missouri, 65613, United States

RECRUITING

Cleaver Dermatology- Site Number : 8400033

Kirksville, Missouri, 63501, United States

RECRUITING

Allergy Asthma & Immunology- Site Number : 8400044

Lincoln, Nebraska, 68510, United States

RECRUITING

Las Vegas Dermatology- Site Number : 8400002

Las Vegas, Nevada, 89144, United States

RECRUITING

Optima Research Portsmouth- Site Number : 8400032

Portsmouth, New Hampshire, 03801, United States

RECRUITING

Piedmont Plastic Surgery and Dermatology- Site Number : 8400038

Huntersville, North Carolina, 28078, United States

RECRUITING

Red River Research Partners - Fargo- Site Number : 8400037

Fargo, North Dakota, 58103, United States

RECRUITING

Dermatologists of Southwest Ohio - Mason- Site Number : 8400050

Mason, Ohio, 45040, United States

RECRUITING

Care Access Research - Warwick 2- Site Number : 8400045

Warwick, Rhode Island, 02886, United States

RECRUITING

Advanced Dermatology and Cosmetic Surgery - Spartanburg- Site Number : 8400004

Spartanburg, South Carolina, 29307, United States

RECRUITING

Reveal Research Institute - Dallas- Site Number : 8400012

Dallas, Texas, 75235, United States

RECRUITING

Innovate Research - Fort Worth- Site Number : 8400016

Fort Worth, Texas, 76244, United States

RECRUITING

Austin Institute for Clinical Research, Inc- Site Number : 8400030

Pflugerville, Texas, 78660, United States

RECRUITING

Complete Dermatology - Sugar Land- Site Number : 8400001

Sugar Land, Texas, 77479, United States

RECRUITING

Cope Family Medicine Ogden Clinic- Site Number : 8400053

Bountiful, Utah, 84010-8917, United States

RECRUITING

Fuchs Dermatology- Site Number : 8400027

Falls Church, Virginia, 22042, United States

RECRUITING

Frontier Dermatology Partners CRO LLC- Site Number : 8400011

Mill Creek, Washington, 98012, United States

RECRUITING

Origins Dermatology Centre-Site Number : 1240003

Regina, Saskatchewan, S4V 1R9, Canada

RECRUITING

The First Affiliated Hospital of Ningbo University-Site Number : 1560009

Ningbo, Zhejiang, 315010, China

RECRUITING

GHRMSA - Hospital Emile Muller-Site Number : 2500006

Mulhouse, Haut Rhin, 68100, France

RECRUITING

Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia-Site Number : 3800006

Reggio Emilia, 42100, Italy

RECRUITING

King Fahad Medical City-Site Number : 6820001

Riyadh, 12231, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; Contact-US@sanofi.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 18, 2025
• Study Start: November 17, 2025
• Primary Completion (Estimated): January 30, 2034
• Study Completion (Estimated): January 30, 2034
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (38); FR (1); SA (1); CN (1); IT (1); CA (1)