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 2026-11-02.
Sponsored by Sanofi · Observational
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Among 43 studies in Dermatitis, Atopic by Sanofi — 5 open to participants now, 16 under way, 4 of them phase 3. Dermatitis, Atopic · Sanofi.
Among the 43 studies in Dermatitis, Atopic by Sanofi, this one is the 2nd largest by planned enrollment of the 15 observational ones that give a count, is one of 3 that started in 2025, is one of 15 observational ones, reaches primary completion later than 14 of the 15 other live ones, and was the 40th registered.
1,592 studies on the registry are indexed under Dermatitis, Atopic; 287 are open to participants now.
Browse Dermatitis, Atopic studies →5 of the 43 studies in Dermatitis, Atopic by Sanofi are open now, in 10 countries. Recruiting first, the newest first:
Sanofi · Sites in Qatar, Saudi Arabia, United Arab Emirates
Ages 12+
Sanofi · Sites in Italy
Ages 6 mo–17 yrs
Sanofi
Ages 12+
Sanofi
Ages 18+
By country, each count listing its studies:
Of the 195 Dermatitis, Atopic studies recruiting now, 83 (43%) set no upper age limit and 96 (49%) stop at 75 or younger; 94 take children under 18; 52 take healthy volunteers.
This study: 12 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
43 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 10 · Phase 3 10 · Phase 4 8
First in 2006; this study’s year is marked. 3 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 1,000 is above the median of 150 across 283 observational studies indexed under Dermatitis, Atopic.
Median enrollment 112 across the 28 interventional studies, 266 across the 15 observational. Of the 26 that completed or were terminated, 9 (35%) have results posted.
This tab as a report to print or save as PDF → With an account.
Sanofi is the lead sponsor of 1,558 studies on the registry; 89 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.
6 of the studies in Dermatitis, Atopic by Sanofi that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06241118Phase 3SanofiA Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor | 2027-09-30 |
| NCT07905547SanofiA Study to Investigate Dupixent/ Dupilumab in Adult Indian Participants With Moderate-to-severe Atopic Dermatitis | 2027-02-07 |
| NCT03992417SanofiObservational Study of Patients Receiving Dupixent® for Atopic Dermatitis (AD) | 2027-03-31 |
| NCT05983068SanofiA Study of Long-term Effect of Dupilumab on Skin Barrier Function in Pediatric Participants With Atopic Dermatitis | 2027-04-29 |
| NCT06837454SanofiFrench Prospective Observational Study in Patients Eligible for Systemic Therapy for Atopic Dermatitis (AD) | 2027-05-13 |
Add all 6 to your calendar (.ics) → With an account.
Among the 43 studies in Dermatitis, Atopic by Sanofi, from their registry updates:
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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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
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Jan 2034, 98 months after the start.
Of 74 industry-sponsored observational studies under Dermatitis, Atopic, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 84. This study's planned 98 months is above that.
Counting every sponsor, half of 171 studies reached it within 35 months; a quarter within 17.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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