NCT07290803 · Sanofi
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)
What this study is about
The objectives of this forward-looking 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.
View original scientific description
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.
Primary outcome measures
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.
Duration of Treatment
Time frame: Baseline to up to 60 months
The duration of AD treatments will be summarized descriptively.
AD Treatment Sequences
Time frame: Baseline to up to 60 months
The ordering of AD treatments will be summarized descriptively.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Remission of AD
Time frame: Baseline to up to 60 months
Total remission of all signs and symptoms of AD will be assessed.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Birmingham, Alabama
- Montgomery, Alabama
- Gilbert, Arizona
- Phoenix, Arizona
- Bakersfield, California
- Fremont, California
- Los Angeles, California
- Northridge, California
- Oakland, California
- Pomona, California
- San Diego, California
- Wheat Ridge, Colorado
And 34 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 6, 2026 · Source of record for eligibility and locations