MedDataX Logo

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

NCT ID: NCT07290803

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-17

Study Completion Date

2034-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atopic Dermatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sunwise Clinical Research, LLC.- Site Number : 8400010

Oakland, California, United States

Site Status RECRUITING

Clinical Trials Research Institute.- Site Number : 8400009

Thousand Oaks, California, United States

Site Status NOT_YET_RECRUITING

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

Wheat Ridge, Colorado, United States

Site Status RECRUITING

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

Macon, Georgia, United States

Site Status RECRUITING

Allergy Asthma & Immunology- Site Number : 8400044

Lincoln, Nebraska, United States

Site Status RECRUITING

Las Vegas Dermatology- Site Number : 8400002

Las Vegas, Nevada, United States

Site Status RECRUITING

Optima Research Portsmouth- Site Number : 8400032

Portsmouth, New Hampshire, United States

Site Status RECRUITING

Innovate Research - Fort Worth- Site Number : 8400016

Fort Worth, Texas, United States

Site Status RECRUITING

Complete Dermatology - Sugar Land- Site Number : 8400001

Sugar Land, Texas, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

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

Role: CONTACT

Phone: 800-633-1610

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U1111-1311-1824

Identifier Type: REGISTRY

Identifier Source: secondary_id

OBS18388

Identifier Type: -

Identifier Source: org_study_id