An observational study in Atopic Dermatitis, sponsored by Sanofi. Recruiting at 82 sites in 9 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Sanofi · Observational
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.
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.
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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.
Number of Participants Utilizing Atopic Dermatitis (AD) Treatment
The number (and percentage) of participants taking AD treatments and treatments per patient will be described.
Time frame: Baseline to up to 60 months
Duration of Treatment
The duration of AD treatments will be summarized descriptively.
Time frame: Baseline to up to 60 months
AD Treatment Sequences
The ordering of AD treatments will be summarized descriptively.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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)
Clinical outcomes measured using EASI will be summarized at the start of a treatment episode and each follow-up time point.
Time frame: 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.
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)
Clinical outcomes measured using vIGA-AD will be summarized at the start of a treatment episode and each follow-up time point.
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)
Clinical outcomes measured using rIGA-AD will be summarized at the start of a treatment episode and each follow-up time point.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to up to 60 months
Remission of AD
Total remission of all signs and symptoms of AD will be assessed.
Time frame: Baseline to up to 60 months
Sociodemographic characteristics of Participants
Demographics characteristics including age, sex, body weight, height, geographic region, education level, employment status, smoking and alcohol status will be collected.
Time frame: Baseline
Ethnic Origin in Combination with Fitzpatrick Scale
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.
Time frame: Baseline
Disease characteristics of Participants
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.
Time frame: Baseline
Change from Baseline in Dermatology-specific Quality of Life Measure with Dermatology Life Quality Index (DLQI)
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).
Time frame: Baseline to up to 60 months
Change from Baseline in Dermatology-specific Quality of Life Measure with Children's Dermatology Life Quality Index (CDLQI)
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).
Time frame: Baseline to up to 60 months
Change from Baseline in Burden of Assessment Using Patient Health Questionnaire-9 (PHQ-9)
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".
Time frame: Baseline to up to 60 months
Change from Baseline in AD Specific Work and Classroom Productivity and Impairment Assessed Using WPAI+CIQ
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.
Time frame: Baseline to up to 60 months
Change from Baseline in Treatment Satisfaction Assessed Using Treatment Satisfaction Questionnaire for Medication (TSQM-9)
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.
Time frame: Baseline to up to 60 months
Visits with Specialty of Attending Healthcare Provider and Reason for Visit
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.
Time frame: Baseline to up to 60 months
Hospitalizations for AD
Hospitalization for AD will be assessed.
Time frame: Baseline to up to 60 months
Prevalence of Comorbid Atopic Conditions
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.
Time frame: Baseline to up to 60 months
Incidence of Comorbid Atopic Conditions
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.
Time frame: Baseline to up to 60 months
Change from Baseline in Asthma Control Assessed with Asthma Control Questionnaire-5 (ACQ-5)
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.
Time frame: Baseline to up to 60 months
Occurrence of Concomitant Medication use for AD and Selected Comorbidities
The occurrence of concomitant medication use for AD and selected comorbidities at baseline and changes (including reason for change) will be summarized.
Time frame: Baseline to up to 60 months
Number of Adverse Events (SAEs)
Number of patients experiencing AEs.
Time frame: Baseline to up to 60 months
Number of Serious Adverse Events (SAEs)
Number of patients experiencing SAEs.
Time frame: Baseline to up to 60 months
Plan to share: Yes — 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
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