A Study to Observe How Pediatric Patients With Severe Atopic Dermatitis Despite Less Extensive Skin Lesions Respond to Dupilumab Treatment

NCT06192563 | Recruiting

• 2 other identifiers: OBS18015U1111-1290-5921
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 9

Brief Summary

In adolescents treated with dupilumab, clinical trials showed significant improvement of atopic dermatitis (AD) signs and symptoms, with a good safety profile. In these clinical trials, only patients with Eczema Area and Severity Index (EASI) score greater than or equal to (≥) 16 were enrolled, and effectiveness on sensitive/visible areas was not specifically evaluated. Further data about the effectiveness of dupilumab in adolescent and children participants with moderate to mild EASI score and severe itching and/or localized AD to better understand the potential clinical benefits of dupilumab in these populations. The main objective of the study us to assess the real-word effectiveness and safety of dupilumab in pediatric patients (age 6 months-17 years) who suffer from severe AD with EASI score \< 16 for adolescents (age 12-17 years) and \< 21 for children (age 6 months-11 years), and who are eligible for systemic therapy according to Italian reimbursement criteria.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (41)

• Children and Adolescents: Percentage (%) change from baseline in Eczema Area and Severity Index (EASI) score

  EASI measures the severity \& extent of AD based on 4 AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\] \& lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicating greater severity of AD. EASI-50: ≥ 50% reduction in score from baseline; EASI-75: ≥ 75% reduction in score from baseline; EASI-90: ≥ 90% reduction in score from baseline.

  Baseline, Weeks 4, 16 and 52

• Children and Adolescents: Percentage (%) of participants with EASI-50

  EASI measures the severity \& extent of AD based on 4 AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\] \& lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicating greater severity of AD. EASI-50: ≥ 50% reduction in score from baseline; EASI-75: ≥ 75% reduction in score from baseline; EASI-90: ≥ 90% reduction in score from baseline.

  Weeks 4, 16, 52

• Children and Adolescents: Percentage (%) of participants with EASI-75

  EASI measures the severity \& extent of AD based on 4 AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\] \& lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicating greater severity of AD. EASI-50: ≥ 50% reduction in score from baseline; EASI-75: ≥ 75% reduction in score from baseline; EASI-90: ≥ 90% reduction in score from baseline.

  Weeks 4, 16, 52

• Children and Adolescents: Percentage (%) of participants with EASI-90

  EASI measures the severity \& extent of AD based on 4 AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\] \& lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicating greater severity of AD. EASI-50: ≥ 50% reduction in score from baseline; EASI-75: ≥ 75% reduction in score from baseline; EASI-90: ≥ 90% reduction in score from baseline.

  Weeks 4, 16, 52

• Children and Adolescents: Change from baseline in Patient Oriented Eczema Measure (POEM) score

  The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a scale ranging from 0 to 4 (0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, 4 = all days). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). Higher scores indicate more severe disease and poor quality of life.

  Baseline, Weeks 4, 16, 52

• Children and Adolescents: Percentage (%) of children (6-11 years) and adolescents with a ≥ 6-point improvement from baseline in POEM score

  The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a scale ranging from 0 to 4 (0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, 4 = all days). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). Higher scores indicate more severe disease and poor quality of life.

  Baseline, Weeks 4, 16, 52

• Children and Adolescents: Percentage of Infants (6 months-5 years) with a ≥ 3-point Improvement From Baseline in POEM score

  The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a scale ranging from 0 to 4 (0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, 4 = all days). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). Higher scores indicate more severe disease and poor quality of life.

  Baseline, Weeks 4, 6 and 52

• Children and Adolescents: Percentage (%) of participants with adverse events

  Baseline to Week 52

• Children only: Mean Absolute Change from Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score

  The SCORAD is a clinical tool used to assess the extent and severity of eczema. The SCORAD for each individual is A/5 + 7B/2 + C. Total score:0-103 A: Area: to determine extent, the sites affected by eczema are shaded on a drawing of a body. The rule of 9 is used to calculate the affected area (A) as a percentage of the whole body. The score for each area is added up. The total area is 'A', which has a possible maximum of 100 percent (%). B: Intensity: A representative area of eczema is selected. In this area, the intensity of each of the following signs is assessed as none (0), mild (1), moderate (2) or severe (3). The intensity scores are added together to give 'B' (maximum 18). C: Subjective symptoms (itch and sleeplessness) are each scored by the patient or relative using a visual analogue scale where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum 20).

  Baseline, Weeks 4,6 and 52

• Children only: Percentage Change from Baseline in SCORAD

  The SCORAD is a clinical tool used to assess the extent and severity of eczema. The SCORAD for each individual is A/5 + 7B/2 + C. Total score:0-103 A: Area: to determine extent, the sites affected by eczema are shaded on a drawing of a body. The rule of 9 is used to calculate the affected area (A) as a percentage of the whole body. The score for each area is added up. The total area is 'A', which has a possible maximum of 100 percent (%). B: Intensity: A representative area of eczema is selected. In this area, the intensity of each of the following signs is assessed as none (0), mild (1), moderate (2) or severe (3). The intensity scores are added together to give 'B' (maximum 18). C: Subjective symptoms (itch and sleeplessness) are each scored by the patient or relative using a visual analogue scale where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum 20).

  Baseline, Weeks 4, 16 and 52

• Adolescents: Percentage (%) change from baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) at 4, 16, 52 weeks

  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.

  Baseline, Weeks 4, 16 and 52

• Adolescents: Participant assessment: Percentage (%) of participants with a ≥4-point improvement from baseline in PP-NRS at 4, 16, 52 weeks

  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.

  Baseline, Weeks 4, 16 and 52

• Adolescents: Percentage (%) of participants with a PP-NRS score of 0, 1 to 3, and 4 to 6 at 4, 16, 52 weeks (only patients with baseline PP-NRS ≥ 7

  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.

  Weeks 4, 16 and 52

• Children: Absolute Change from Baseline in SCORAD itch VAS

  The SCORAD is a clinical tool used to assess the extent and severity of eczema. The SCORAD for each individual is A/5 + 7B/2 + C. Total score:0-103 A: Area: to determine extent, the sites affected by eczema are shaded on a drawing of a body. The rule of 9 is used to calculate the affected area (A) as a percentage of the whole body. The score for each area is added up. The total area is 'A', which has a possible maximum of 100 percent (%). B: Intensity: A representative area of eczema is selected. In this area, the intensity of each of the following signs is assessed as none (0), mild (1), moderate (2) or severe (3). The intensity scores are added together to give 'B' (maximum 18). C: Subjective symptoms (itch and sleeplessness) are each scored by the patient or relative using a visual analogue scale where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum 20).

  Baseline, Weeks 4, 16 and 52

• Children: Percentage of Patients with Mild or no Itch (SCORAD itch VAS < 4)

  The SCORAD is a clinical tool used to assess the extent and severity of eczema. The SCORAD for each individual is A/5 + 7B/2 + C. Total score:0-103 A: Area: to determine extent, the sites affected by eczema are shaded on a drawing of a body. The rule of 9 is used to calculate the affected area (A) as a percentage of the whole body. The score for each area is added up. The total area is 'A', which has a possible maximum of 100 percent (%). B: Intensity: A representative area of eczema is selected. In this area, the intensity of each of the following signs is assessed as none (0), mild (1), moderate (2) or severe (3). The intensity scores are added together to give 'B' (maximum 18). C: Subjective symptoms (itch and sleeplessness) are each scored by the patient or relative using a visual analogue scale where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum 20).

  Baseline, Weeks 4, 16 and 52

• Adolescents: Percentage (%) change from baseline in Sleep Disturbance Numerical Rating Scale (SD-NRS) at 4, 16, 52 weeks

  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".

  Baseline, Weeks 4, 16 and 52

• Children: Mean Absolute Change from Baseline in SCORAD sleep VAS

  The SCORAD is a clinical tool used to assess the extent and severity of eczema. The SCORAD for each individual is A/5 + 7B/2 + C. Total score:0-103 A: Area: to determine extent, the sites affected by eczema are shaded on a drawing of a body. The rule of 9 is used to calculate the affected area (A) as a percentage of the whole body. The score for each area is added up. The total area is 'A', which has a possible maximum of 100 percent (%). B: Intensity: A representative area of eczema is selected. In this area, the intensity of each of the following signs is assessed as none (0), mild (1), moderate (2) or severe (3). The intensity scores are added together to give 'B' (maximum 18). C: Subjective symptoms (itch and sleeplessness) are each scored by the patient or relative using a visual analogue scale where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum 20).

  Baseline, Weeks 4, 16, and 52

• Children: Percentage Change from Baseline in SCORAD Sleep VAS

  The SCORAD is a clinical tool used to assess the extent and severity of eczema. The SCORAD for each individual is A/5 + 7B/2 + C. Total score:0-103 A: Area: to determine extent, the sites affected by eczema are shaded on a drawing of a body. The rule of 9 is used to calculate the affected area (A) as a percentage of the whole body. The score for each area is added up. The total area is 'A', which has a possible maximum of 100 percent (%). B: Intensity: A representative area of eczema is selected. In this area, the intensity of each of the following signs is assessed as none (0), mild (1), moderate (2) or severe (3). The intensity scores are added together to give 'B' (maximum 18). C: Subjective symptoms (itch and sleeplessness) are each scored by the patient or relative using a visual analogue scale where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum 20).

  Baseline, Weeks 4, 16 and 52

• Adolescents: Percentage (%) change from baseline in Children's Dermatology Life Quality Index (CDLQI) at 4, 16, 52 weeks

  The CDLQI is a validated questionnaire designed to measure the impact of skin disease on the Quality of Life. The higher the score, the greater the impact is on the quality of life.

  Baseline, Weeks 4, 16 and 52

• Adolescents: Percentage (%) of participants who achieve a ≥6-point reduction from baseline in CDLQI score at 4, 16, 52 weeks

  The CDLQI is a validated questionnaire designed to measure the impact of skin disease on the Quality of Life. The higher the score, the greater the impact is on the quality of life.

  Baseline, Weeks 4, 16 and 52

• Adolescents: Percentage of Participants with cDLQI Score of 0-1

  The CDLQI is a validated questionnaire designed to measure the impact of skin disease on the Quality of Life. The higher the score, the greater the impact is on the quality of life.

  Weeks 4, 16 and 52

• Adolescents: Percentage (%) of Participants with CDLQI Score of < 6 at 4, 16, 52 weeks (only patients with CDLQI ≥ 10 at baseline)

  The CDLQI is a validated questionnaire designed to measure the impact of skin disease on the Quality of Life. The higher the score, the greater the impact is on the quality of life.

  Weeks 4, 16 and 52

• Children: Mean Absolute Change from Baseline cDLQI / Infants' Dermatitis Quality of Life Index (iDQoL) (for patients ˂ 4 years of age)

  The iDQoL is a questionnaire completed by parents to assess the impact of atopic dermatitis on the quality of life of infants aged 0-3 years (i.e., up to 3 years 11 months. The Index is calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

  Weeks 4, 16 and 52

• Children: Percentage of Participants who Achieve a ≥ 6-point Reduction from Baseline in cDLQI / iDQoL (for patients ˂ 4 years of age)

  The iDQoL is a questionnaire completed by parents to assess the impact of atopic dermatitis on the quality of life of infants aged 0-3 years (i.e., up to 3 years 11 months. The Index is calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

  Weeks 4, 16 and 52

• Children: Percentage of Participants with cDLQI / iDQoL (for patients ˂ 4 years of age) Score of 0-1

  The iDQoL is a questionnaire completed by parents to assess the impact of atopic dermatitis on the quality of life of infants aged 0-3 years (i.e., up to 3 years 11 months. The Index is calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

  Weeks 4, 16 and 52

• Children: Percentage of Participants with cDLQI / iDQoL (for patients ˂ 4 years of age) score < 6

  The iDQoL is a questionnaire completed by parents to assess the impact of atopic dermatitis on the quality of life of infants aged 0-3 years (i.e., up to 3 years 11 months. The Index is calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

  Weeks 4, 16 and 52

• Adolescents: Percentage (%) change from baseline in Hospital Anxiety and Depression Scale (HADS) at 4, 16, 52 weeks

  The HADS is a 14-item patient-reported outcomes measure used to assess states of anxiety and depression over the past week. It is comprised of 7 items assessing anxiety and depression respectively. A Total score is out of 42 (21 per subscale). Higher scores indicate greater levels of anxiety and/or depression.

  Baseline, Weeks 4, 16 and 52

• Children: Percentage (%) Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) score

  PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The total raw score is translated into a T-score for each participant by means of conversion table. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10.

  Baseline, Weeks 4, 16 and 52

• Adolescents: Percentage (%) change from baseline Atopic Dermatitis Control Tool (ADCT) score at 4, 16, 52 weeks

  ADCT is a six-item patient self-administered instrument designed and validated to assess atopic dermatitis (AD) control. The score ranges from 0-24 with higher scores indicating worsening disease control.

  Baseline, Weeks 4, 16 and 52

• Adolescents: Participant assessment: Percentage (%) of participants with ADCT < 7 at 4, 16, 52 weeks

  ADCT is a six-item patient self-administered instrument designed and validated to assess atopic dermatitis (AD) control. The score ranges from 0-24 with higher scores indicating worsening disease control.

  Weeks 4, 16 and 52

• Children and Adolescents: Percentage (%) change from baseline the Dermatitis Family Impact (DFI) questionnaire at 4, 16, 52 weeks

  The DFI is a 10-item disease specific questionnaire assessing the impact of having a child with AD on family Quality of Life (QoL). The DFI questions are scored on a four-point Likert scale ranging from 0 to 3, and the total DFI score ranges from 0 to 30. The time frame of reference is the past week, and a higher DFI score indicates greater impairment in family QoL as affected by AD.

  Baseline, Weeks 4, 16 and 52

• Children and Adolescents: Percentage (%) of Participants with Physician's Global Assessment (PGA) Face 0 or (/) 1, PGA Feet 0/1, PGA Hands 0/1, PGA Genitals 0/1 and at least a 2-point Improvement from Baseline

  The PGA score is a measure used in clinical practice and clinical trials to assess the severity of a particular disease. The PGA chosen for this study ranges from 0-5 point, and the following categories will be used: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe. In this study, the Investigator will be evaluating four PGA scores, including PGA face, PGA feet, PGA hands, and PGA genitalia, in order to assess the severity of the localized lesions in AD patients at baseline and at week 4, 16 and 52.

  Baseline, Weeks 4, 16 and 52

• Adolescents: Percentage (%) of Participants with PGA Genitals 0/1 and at least a 2-point Improvement from Baseline

  The PGA score is a measure used in clinical practice and clinical trials to assess the severity of a particular disease. The PGA chosen for this study ranges from 0-5 point, and the following categories will be used: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe. In this study, the Investigator will be evaluating four PGA scores, including PGA face, PGA feet, PGA hands, and PGA genitalia, in order to assess the severity of the localized lesions in AD patients at baseline and at week 4, 16 and 52.

  Baseline, Weeks 4, 16 and 52

• Children and Adolescents: Time to Discontinuation and Reasons for Discontinuation

  Baseline up to Week 52

• Mean Time to First TCS/TCI Discontinuation.

  Baseline up to Week 52

• Children: Percentage of Patients that Discontinue Topical Corticosteroids (TCS) and Topical Calcineurin Inhibitors (TCI)

  Baseline, Weeks 4, 16 and 52

• Adolescents: Participant assessment: Mean score of Treatment Satisfaction Questionnaire for Medication (TSQM-9) score at 4, 16, 52 weeks

  The 9-item TSQM (TSQM-9) is a questionnaire to assess treatment satisfaction, with scores ranging between 9 and 59, and lower scores indicating lower satisfaction with treatment.

  Weeks 4, 16 and 52

• Adolescents: Percentage (%) change from baseline in Asthma Control Questionnaire (ACQ-6) at 4, 16, 52 weeks in participants with concomitant asthma

  The ACQ-6 is a questionnaire that consists of six questions on a scale from 0 to 6 of symptoms. The questions are about limitations due to asthma and symptoms in the past week. A lower score corresponds with better asthma control.

  Baseline, Weeks 4, 16 and 52

• Children: Mean Absolute Change from Baseline in Pediatric Asthma Questionnaire (PAQ)

  The PAQ is a 6-item measure for parents or caregivers of children aged 0-11 years with clinician-diagnosed asthma, or those with recurrent viral-associated wheezing with risk factors for persistent asthma, to assess both symptom control and asthma-specific HRQoL impact. The PAQ features two items that measure asthma exacerbations which use a recall period of "the past month" while the remaining asthma symptoms (coughing a lot, difficulty breathing, or noisy breathing from the chest) and asthma-specific HRQoL items use "the past week".

  Weeks 4, 16 and 52

• Children: Percentage Change from Baseline in Pediatric Asthma Questionnaire (PAQ)

  The PAQ is a 6-item measure for parents or caregivers of children aged 0-11 years with clinician-diagnosed asthma, or those with recurrent viral-associated wheezing with risk factors for persistent asthma, to assess both symptom control and asthma-specific HRQoL impact. The PAQ features two items that measure asthma exacerbations which use a recall period of "the past month" while the remaining asthma symptoms (coughing a lot, difficulty breathing, or noisy breathing from the chest) and asthma-specific HRQoL items use "the past week".

  Weeks 4, 16 and 52

• Children and Adolescents: Percentage (%) change from baseline in Total Nasal Symptoms Score (TNSS) at 4, 16, 52 weeks in participants with concomitant chronic rhinitis

  The TNSS is the sum of scores for each of nasal congestion, sneezing, nasal itching, and rhinorrhea using a four-point scale (0-3), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. TNSS is calculated by adding the score for each of the symptoms to a total out of 12.

  Baseline, Weeks 4, 16 and 52

Study Arms (1)

Pediatric patients with AD

Pediatric participants (6 months to 17 years) who suffer from severe AD with EASI score \< 16 for adolescents (age 12-17 years) and \< 21 for children (6 months to 11 years), eligible for systemic dupilumab treatment according to Italian reimbursement criteria.

Drug: Dupilumab

Interventions

Dupilumab DRUG

This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.

Also known as: SAR231893 (REGN668), Dupixent®

Pediatric patients with AD

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric (aged 6 months to 17 years) participants who suffer from severe AD with EASI score \< 16 for adolescents (age 12-17 years) and \< 21 for children (age 6 months-11 years), and who are eligible for systemic therapy according to Italian reimbursement criteria.

You may qualify if:

• Male or female, aged between 6 months and 17 years at the baseline visit.
• Patients with AD who have been prescribed dupilumab as per clinical practice (according to AIFA reimbursement policy) and who fulfill the following criteria:
• \-- Adolescents (12 to 17 years old) with EASI \< 16 and children (6 months to 11 years of age) with EASI \< 21 and.
• Children's Dermatology Life Quality Index (cDLQI)\* ≥ 10 and / or
• Itch NRS ≥ 7 and / or
• Localization in visible or sensitive areas (head/neck/hands or genitals)
• Participants/ caregivers able to understand and complete study-related questionnaires.
• Provided signed informed consent or parental/legally acceptable representative consent and participant assent where applicable.
• Only for adolescents and children 6-11 years of age.

You may not qualify if:

• Use of dupilumab within 6 months prior to study entry.
• Participants currently participating in any interventional clinical trial that modifies patient care.
• Any condition that, in the opinion of the Investigator, may interfere with participant's ability to participate in the study (e.g., substance abuse).
• The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Sponsors & Collaborators

• Regeneron Pharmaceuticals: collaborator
• Sanofi: lead

Study Sites (9)

Investigational Site Number: 002

Bologna, 40138, Italy

RECRUITING

Investigational Site Number: 006

Brescia, 25123, Italy

RECRUITING

Investigational Site Number: 004

Florence, 50139, Italy

RECRUITING

Investigational Site Number: 001

Milan, 20122, Italy

RECRUITING

Investigational Site Number: 010

Naples, 80131, Italy

RECRUITING

Investigational Site Number: 011

Naples, 80138, Italy

RECRUITING

Investigational Site Number: 005

Roma, 00133, Italy

RECRUITING

Investigational Site Number: 009

Roma, 00168, Italy

RECRUITING

Investigational Site Number: 014

Verona, 37134, Italy

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

800-633-1610; contact-us@sanofi.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 5, 2024
• Study Start: November 30, 2023
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

IT (9)