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
| NCT ID | NCT06192563 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sanofi |
| Condition | Dermatitis Atopic |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-11-30 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2023-11-30 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Trial Transparency email recommended (Toll free for US & Canada)
✉ contact-us@sanofi.com📞 800-633-1610
Clinical Sciences & Operations
STUDY DIRECTOR
Sanofi
Frequently Asked Questions
Who can join the NCT06192563 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 17 Years, studying Dermatitis Atopic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06192563 currently recruiting?
Yes, NCT06192563 is actively recruiting participants. Contact the research team at contact-us@sanofi.com for enrollment information.
Where is the NCT06192563 trial being conducted?
This trial is being conducted at Bologna, Italy, Brescia, Italy, Florence, Italy, Milan, Italy and 5 additional locations.
Who is sponsoring the NCT06192563 clinical trial?
NCT06192563 is sponsored by Sanofi. The principal investigator is Clinical Sciences & Operations at Sanofi. The trial plans to enroll 150 participants.