Recruiting

Atopic Dermatitis

Sponsor:

Sanofi

Code:

NCT07290803

Conditions

Atopic Dermatitis

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT07290803

Start date

Nov 17, 2025

Status verified date

Aug, 2026

Completion date

Jan 30, 2034

Anticipated

Primary completion date

Jan 30, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Number of Participants Utilizing Atopic Dermatitis (AD) Treatment [ Time Frame: Baseline to up to 60 months ]
  • Duration of Treatment [ Time Frame: Baseline to up to 60 months ]
  • AD Treatment Sequences [ Time Frame: Baseline to up to 60 months ]
  • Number of Participants Initiating AD Treatments with Reasons [ Time Frame: Baseline to up to 60 months ]
  • Number of Participants Interrupting AD Treatment [ Time Frame: Baseline to up to 60 months ]
  • Number of Participants Discontinuing AD Treatment [ Time Frame: Baseline to up to 60 months ]
  • Number of Participants Switching AD Treatments [ Time Frame: Baseline to up to 60 months ]
  • Number of Participants Augmenting AD treatment [ Time Frame: Baseline to up to 60 months ]
  • Number of Participants Modifying AD Treatment Dose [ Time Frame: 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 ]
  • Change from Baseline in Extent and Severity of AD Measured with Body Surface Area (BSA) [ Time Frame: 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 ]
  • 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 ]
  • Change in Atopic Dermatitis Control Test (ADCT) from Baseline [ Time Frame: Baseline to up to 60 months ]
  • Change in Patient Global Impression of Severity (PGIS) from Baseline [ Time Frame: 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 ]
  • Change in Skin Pain as Measured with Skin Pain Numeric Rating Scale (SP-NRS) from Baseline [ Time Frame: 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 ]
  • Remission of AD [ Time Frame: Baseline to up to 60 months ]

Central Contacts and Locations

Central contacts

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

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

Locations

Cahaba Dermatology & Skin Health Center- Site Number : 8400006

Recruiting

Birmingham, Alabama, United States, 35244

Contacts

Principal Investigator:

Vlada Groysman

River Region Dermatology and Laser- Site Number : 8400041

Recruiting

Montgomery, Alabama, United States, 36117

Contacts

Principal Investigator:

Porcia Love

San Tan Allergy & Asthma- Site Number : 8400031

Recruiting

Gilbert, Arizona, United States, 85234

Contacts

Principal Investigator:

Sam Reed Shimamoto

Saguaro Dermatology- Site Number : 8400028

Recruiting

Phoenix, Arizona, United States, 85008

Contacts

Principal Investigator:

Dathan Hamann

Kern Research, Inc.- Site Number : 8400047

Recruiting

Bakersfield, California, United States, 93301

Contacts

Principal Investigator:

Tonny Tanus

Center for Dermatology Clinical Research- Site Number : 8400014

Recruiting

Fremont, California, United States, 94538

Contacts

Principal Investigator:

Sunil Dhawan

Dermatology Research Associates - Los Angeles- Site Number : 8400020

Recruiting

Los Angeles, California, United States, 90045

Contacts

Principal Investigator:

Howard Sofen

Northridge Clinical Trials, LLC- Site Number : 8400009

Recruiting

Northridge, California, United States, 91325

Contacts

Principal Investigator:

Navid Ezra

Sunwise Clinical Research, LLC.- Site Number : 8400010

Recruiting

Oakland, California, United States, 94596

Contacts

Michael Abdel Malek

9252985147mike@sunclin.com

Principal Investigator:

Michael Abdel Malek

Empire Clinical Research, LLC- Site Number : 8400007

Recruiting

Pomona, California, United States, 91767

Contacts

Principal Investigator:

Radhika Shah

University Clinical Trials- Site Number : 8400019

Recruiting

San Diego, California, United States, 92123

Contacts

Principal Investigator:

Walter Nahm

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

Recruiting

Wheat Ridge, Colorado, United States, 80033

Contacts

Principal Investigator:

Jeffrey Rumbyrt

St. Jude Clinical Research- Site Number : 8400049

Recruiting

Doral, Florida, United States, 33172

Contacts

Principal Investigator:

Gustavo Torres

Ziaderm Research, LLC- Site Number : 8400021

Recruiting

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

Contacts

Principal Investigator:

Tory Sullivan

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

Recruiting

Macon, Georgia, United States, 31217

Contacts

Principal Investigator:

David Cohen

Sneeze, Wheeze, & Itch Associates, LLC- Site Number : 8400029

Recruiting

Normal, Illinois, United States, 61761

Contacts

Principal Investigator:

Dareen Siri

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

Recruiting

North Chicago, Illinois, United States, 60064

Contacts

Principal Investigator:

Raj Chovatiya

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

Recruiting

Ann Arbor, Michigan, United States, 48103

Contacts

Principal Investigator:

David Fivenson

Oakland Hills Dermatology- Site Number : 8400042

Recruiting

Auburn Hills, Michigan, United States, 48326

Contacts

Principal Investigator:

Christofer Buatti

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

Recruiting

Bay City, Michigan, United States, 48706

Contacts

Principal Investigator:

Brent Boyce

The Derm Institute of West Michigan- Site Number : 8400025

Recruiting

Caledonia, Michigan, United States, 49316

Contacts

Principal Investigator:

Kristi Hawley

Wayne State University - Detroit Medical Center- Site Number : 8400035

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Principal Investigator:

Steven Daveluy

Michigan Dermatology Institute - Waterford- Site Number : 8400013

Recruiting

Waterford, Michigan, United States, 48328

Contacts

Principal Investigator:

Cory Rubin

Red River Research Partners, Llc- Site Number : 8400054

Recruiting

Bolivar, Missouri, United States, 65613

Contacts

Principal Investigator:

Murphy Mastin

Cleaver Dermatology- Site Number : 8400033

Recruiting

Kirksville, Missouri, United States, 63501

Contacts

Principal Investigator:

David Cleaver

Allergy Asthma & Immunology- Site Number : 8400044

Recruiting

Lincoln, Nebraska, United States, 68510

Contacts

Principal Investigator:

Robert Szalewski

Las Vegas Dermatology- Site Number : 8400002

Recruiting

Las Vegas, Nevada, United States, 89144

Contacts

Principal Investigator:

Harry Greenberg

Optima Research Portsmouth- Site Number : 8400032

Recruiting

Portsmouth, New Hampshire, United States, 03801

Contacts

Principal Investigator:

Abel Jarell

University Of New Mexico School Of Medicine- Site Number : 8400022

Recruiting

Albuquerque, New Mexico, United States, 87102

Contacts

Principal Investigator:

John Durkin

Piedmont Plastic Surgery and Dermatology- Site Number : 8400038

Recruiting

Huntersville, North Carolina, United States, 28078

Contacts

Principal Investigator:

Nicole Seminara Zambrzycka

Wake Forest University Health Sciences- Site Number : 8400003

Recruiting

Winston-Salem, North Carolina, United States, 27104

Contacts

Principal Investigator:

Steven Feldman

Red River Research Partners - Fargo- Site Number : 8400037

Recruiting

Fargo, North Dakota, United States, 58103

Contacts

Principal Investigator:

Michael Blankinship

Dermatology Associates of Mid-Ohio- Site Number : 8400026

Recruiting

Marion, Ohio, United States, 43302

Contacts

Principal Investigator:

George Scott Drew

Dermatologists of Southwest Ohio - Mason- Site Number : 8400050

Recruiting

Mason, Ohio, United States, 45040

Contacts

Principal Investigator:

Rocco Serrao

UPMC - Department of Dermatology- Site Number : 8400024

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Principal Investigator:

Joe Tung

Care Access Research - Warwick 2- Site Number : 8400045

Recruiting

Warwick, Rhode Island, United States, 02886

Contacts

Principal Investigator:

John Zwetchkenbaum

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

Recruiting

Spartanburg, South Carolina, United States, 29307

Contacts

Principal Investigator:

Amylynne Frankel

Reveal Research Institute - Dallas- Site Number : 8400012

Recruiting

Dallas, Texas, United States, 75235

Contacts

Principal Investigator:

Aaron Farberg

Innovate Research - Fort Worth- Site Number : 8400016

Recruiting

Fort Worth, Texas, United States, 76244

Contacts

Principal Investigator:

Swapnil Vaidya

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

Recruiting

Pflugerville, Texas, United States, 78660

Contacts

Principal Investigator:

Edward Lain

Complete Dermatology - Sugar Land- Site Number : 8400001

Recruiting

Sugar Land, Texas, United States, 77479

Contacts

Principal Investigator:

Bartley Gill

Cope Family Medicine-Site Number : 8400053

Recruiting

Bountiful, Utah, United States, 84010-8917

Springville Dermatology - Springville- Site Number : 8400055

Recruiting

Springville, Utah, United States, 84663

Contacts

Principal Investigator:

Michael Peterson

Fuchs Dermatology- Site Number : 8400027

Recruiting

Falls Church, Virginia, United States, 22042

Contacts

Principal Investigator:

Aaron Fuchs

Frontier Dermatology Partners CRO LLC- Site Number : 8400011

Recruiting

Mill Creek, Washington, United States, 98012

Contacts

Principal Investigator:

Eingun James Song

University of Washington - Roosevelt Location- Site Number : 8400005

Recruiting

Seattle, Washington, United States, 98105

Contacts

Principal Investigator:

Vivian Shi

Origins Dermatology Centre-Site Number : 1240003

Recruiting

Regina, Saskatchewan, Canada, S4V 1R9

Contacts

Principal Investigator:

Rachel Asiniwasis

More Information

Sponsor

Sanofi

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-28. This information was provided to ClinicalTrials.gov by Sanofi on 2026-08-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.