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

Dermatitis Atopic Clinical Trial

— AD-BEASCUITS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06192563
• Other study ID #: OBS18015
• Secondary ID: U1111-1290-5921
• Status: Recruiting
• Start date: November 30, 2023
• Est. completion date: January 31, 2026

Study information

• Verified date: April 2024
• Source: Sanofi
• Contact: Trial Transparency email recommended (Toll free for US & Canada)
• Phone: 800-633-1610
• Email: contact-us[@]sanofi.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis Atopic
• Dermatitis, Atopic

Intervention

Drug:
• Dupilumab
Subcutaneous injection, standard of care as prescribed by treating physician (no investigational drug provided)

Locations

Country	Name	City	State
Italy	Investigational Site Number: 002	Bologna
Italy	Investigational Site Number: 006	Brescia
Italy	Investigational Site Number: 004	Firenze
Italy	Investigational Site Number: 001	Milano
Italy	Investigational Site Number: 010	Napoli
Italy	Investigational Site Number: 011	Napoli
Italy	Investigational Site Number: 005	Roma
Italy	Investigational Site Number: 009	Roma
Italy	Investigational Site Number: 014	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physician assessment: Percentage (%) change from baseline in Eczema Area and Severity Index (EASI) score at Week 4, Week 16 and Week 52	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
Primary	Physician assessment: Percentage (%) of participants with EASI-50 at 4, 16, 52 weeks	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
Primary	Physician assessment: Percentage (%) of participants with EASI-75 at 4, 16, 52 weeks	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
Primary	Physician assessment: Percentage (%) of participants with EASI-90 at 4, 16, 52 weeks	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
Primary	Participant assessment: Change from baseline in Patient Oriented Eczema Measure (POEM) score at 4, 16, 52 weeks	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
Primary	Participant assessment: Percentage (%) of participants with a = 6-point improvement from baseline in POEM score at 4, 16, 52 weeks	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
Primary	Percentage (%) of participants with adverse events		Baseline to Week 52
Primary	Participant assessment: 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
Primary	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
Primary	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	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
Primary	Participant assessment: 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
Primary	Participant assessment: 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
Primary	Participant assessment: 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
Primary	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)	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
Primary	Participant assessment: 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
Primary	Participant assessment: 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
Primary	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
Primary	Participant assessment: 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
Primary	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	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
Primary	Time to discontinuation and reasons for discontinuation		Baseline up to Week 52
Primary	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, 52
Primary	Participant assessment: 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
Primary	Participant assessment: 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