Clinical trial NCT06192563: A Study to Observe How Adolescent Patients With Severe Atopic Dermatitis Despite Less Extensive Skin Lesions (Eczema Area and Severity Index Score < 16) Respond to Dupilumab Treatment
Official title: A Prospective Observational Study of Adolescent Patients With Severe Atopic Dermatitis Despite Less Extensive Skin Lesions (Eczema Area and Severity Index Score < 16) Receiving Dupilumab
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dermatitis Atopic
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-01-05
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescent (aged 12 to 17 years) participants who suffer from severe AD with EASI score \< 16, eligible for systemic dupilumab treatment according to Italian reimbursement criteria.

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 participants with moderate to mild EASI score and severe itching and/or localized AD are therefore necessary to better understand the potential clinical benefits of dupilumab in these populations.

This is an Italian multicenter, 52-week observational (non-interventional) study which will collect data on the characteristics of adolescent (aged 12 to 17 years) participants who suffer from severe AD with EASI score less than (\<) 16, eligible for systemic dupilumab treatment according to Italian reimbursement criteria. It will study the real-world effectiveness and safety of dupilumab in this population, the effect of dupilumab on itching (pruritus), sleep, quality of life and related outcomes, localized AD in sensitive/visible areas, and on coexisting atopic conditions in adolescent participants who receive dupilumab for AD. It will also document dupilumab treatment satisfaction and dupilumab discontinuation in the study participants.

Detailed description: The individual observational period is planned to be up to 52 weeks.

Eligibility criteria: Inclusion Criteria:

* Male or female, aged between 12 and 17 years at the baseline visit
* Patients with AD who have been prescribed dupilumab according to Agenzia Italiana del Farmaco (AIFA) reimbursement criteria and fulfilling the following criteria:

Patients with EASI\<16 and

1. Children's Dermatology Life Quality Index (CDLQI) ≥ 10 or
2. Peak Pruritus Numerical Rating Scale (PP-NRS) ≥ 7 or
3. localization in visible or sensitive areas (head/neck/hands or genitals)

   * Patients able to understand and complete study-related questionnaires
   * Provided signed informed consent or parental/legally acceptable representative consent and patient assent where applicable

Exclusion Criteria:

* Prior use of dupilumab within 6 months prior the study entry
* Patients currently participating in any interventional clinical trial which modifies patient care
* Any condition that, in the opinion of the Investigator, may interfere with patient'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.

Primary outcomes:
measure: Physician assessment: Percentage (%) change from baseline in Eczema Area and Severity Index (EASI) score at Week 4, Week 16 and Week 52
timeFrame: Baseline, Weeks 4, 16 and 52
measure: Physician assessment: Percentage (%) of participants with EASI-50 at 4, 16, 52 weeks
timeFrame: Weeks 4, 16, 52
measure: Physician assessment: Percentage (%) of participants with EASI-75 at 4, 16, 52 weeks
timeFrame: Weeks 4, 16, 52
measure: Physician assessment: Percentage (%) of participants with EASI-90 at 4, 16, 52 weeks
timeFrame: Weeks 4, 16, 52
measure: Participant assessment: Change from baseline in Patient Oriented Eczema Measure (POEM) score at 4, 16, 52 weeks
timeFrame: Baseline, Weeks 4, 16, 52
measure: Participant assessment: Percentage (%) of participants with a ≥ 6-point improvement from baseline in POEM score at 4, 16, 52 weeks
timeFrame: Baseline, Weeks 4, 16, 52
measure: Percentage (%) of participants with adverse events
timeFrame: Baseline to Week 52
measure: Participant assessment: Percentage (%) change from baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) at 4, 16, 52 weeks
timeFrame: Baseline, Weeks 4, 16 and 52
measure: Participant assessment: Percentage (%) of participants with a ≥4-point improvement from baseline in PP-NRS at 4, 16, 52 weeks
timeFrame: Baseline, Weeks 4, 16 and 52
measure: Participant assessment: 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
timeFrame: Weeks 4, 16 and 52
measure: Participant assessment: Percentage (%) change from baseline in Sleep Disturbance Numerical Rating Scale (SD-NRS) at 4, 16, 52 weeks
timeFrame: Baseline, Weeks 4, 16 and 52
measure: Participant assessment: Percentage (%) change from baseline in Children's Dermatology Life Quality Index (CDLQI) at 4, 16, 52 weeks
timeFrame: Baseline, Weeks 4, 16 and 52
measure: Participant assessment: Percentage (%) of participants who achieve a ≥6-point reduction from baseline in CDLQI score at 4, 16, 52 weeks
timeFrame: Baseline, Weeks 4, 16 and 52
measure: Participant assessment: Percentage (%) of participants with CDLQI Score of 0 to 1, 2 to 6 and ˃ 6 at 4, 16, 52 weeks (only patients with CDLQI ≥ 10 at baseline)
timeFrame: Weeks 4, 16 and 52
measure: Participant assessment: Percentage (%) change from baseline in Hospital Anxiety and Depression Scale (HADS) at 4, 16, 52 weeks
timeFrame: Baseline, Weeks 4, 16 and 52
measure: Participant assessment: Percentage (%) change from baseline Atopic Dermatitis Control Tool (ADCT) score at 4, 16, 52 weeks
timeFrame: Baseline, Weeks 4, 16 and 52
measure: Participant assessment: Percentage (%) of participants with ADCT < 7 at 4, 16, 52 weeks
timeFrame: Weeks 4, 16 and 52
measure: Participant assessment: Percentage (%) change from baseline the Dermatitis Family Impact (DFI) questionnaire at 4, 16, 52 weeks
timeFrame: Baseline, Weeks 4, 16 and 52
measure: Physician assessment: 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 at 4, 16, 52 weeks
timeFrame: Baseline, Weeks 4, 16 and 52
measure: Time to discontinuation and reasons for discontinuation
timeFrame: Baseline up to Week 52
measure: Participant assessment: Mean score of Treatment Satisfaction Questionnaire for Medication (TSQM-9) score at 4, 16, 52 weeks
timeFrame: Weeks 4, 16, 52
measure: Participant assessment: Percentage (%) change from baseline in Asthma Control Questionnaire (ACQ-6) at 4, 16, 52 weeks in participants with concomitant asthma
timeFrame: Baseline, Weeks 4, 16 and 52
measure: Participant assessment: Percentage (%) change from baseline in Total Nasal Symptoms Score (TNSS) at 4, 16, 52 weeks in participants with concomitant chronic rhinitis
timeFrame: Baseline, Weeks 4, 16 and 52
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Investigational Site Number: 002
city: Brescia
country: Italy
facility: Investigational Site Number: 006
city: Firenze
country: Italy
facility: Investigational Site Number: 004
city: Milano
country: Italy
facility: Investigational Site Number: 001
city: Napoli
country: Italy
facility: Investigational Site Number: 010
city: Napoli
country: Italy
facility: Investigational Site Number: 011
city: Roma
country: Italy
facility: Investigational Site Number: 005
city: Roma
country: Italy
facility: Investigational Site Number: 009
city: Verona
country: Italy
facility: Investigational Site Number: 014
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: