Delgocitinib Cream for the Treatment of Moderate to Severe Atopic Dermatitis During 8 Weeks in Adults, Adolescents, and Children

Study Overview
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Brief Summary
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This is a multi-center, open-label trial to evaluate safety and pharmacokinetics of topical delgocitinib cream applied to pediatric subjects (2-17 years) and adult subjects (18 years and above) with atopic dermatitis.

Detailed Description
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A phase 1 open-label, multi-centre, single-arm trial to evaluate the safety and pharmacokinetics (including MUsT) of twice daily topical application of delgocitinib cream for 8 weeks in adults, adolescents, and children with moderate to severe atopic dermatitis

Official Title
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A Phase 1 Open-label, Multi-centre, Single-arm Trial to Evaluate the Safety and Pharmacokinetics (Including MUsT) of Twice Daily Topical Application of Delgocitinib Cream for 8 Weeks in Adults, Adolescents, and Children With Moderate to Severe Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: delgocitinib


Participation Criteria
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Eligibility Criteria
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Key Inclusion criteria (Part 1: adults and adolescents; 12 years and above) Diagnosis of atopic dermatitis (AD) as defined by the Hanifin and Rajka (1980) criteria for AD Age 12 years and above at baseline AD involvement of 25-50% treatable body surface area (BSA) at screening and at baseline Moderate to severe AD (Validated Investigator Global Assessment scale for Atopic Dermatitis [vIGA-AD] score of at least 3) at screening and at baseline Key Inclusion criteria (Part 2: children; 2-11 years) Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD Age 2-11 years at baseline History of AD for at least 3 months (children aged 2-5 years), and at least 12 months (children aged 6-11 years) AD involvement of ≥35% treatable BSA at screening and at baseline Moderate to severe AD (vIGA-AD score of at least 3) at screening and at baseline Key Exclusion criteria (Part 1 and 2: subjects aged 2 years and above) Active dermatologic conditions that may interfere with the diagnosis of AD Use of tanning beds or phototherapy within 4 weeks prior to baseline Systemic treatment with immunosuppressive/modulating drugs or corticosteroids within 4 weeks prior to baseline or 3 or more bleach baths any week within 4 weeks prior to baseline Treatment with topical corticosteroids (TCS), topical calcineurin inhibitors (TCIs), topical phosphodiesterase-4, or oral antibiotics within 1 week prior to baseline Clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to baseline Any disorder, which is not stable, and in the investigator's opinion could affect the safety of the subject, influence the results of the trial or impede the subject's ability to complete the trial

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1: adults and adolescents (12 years and above)<br>Delgocitinib cream (dosage: A mg/g). | Drug: delgocitinib<br>* Cream for topical application<br>* Other names: LEO 124249;|
| Experimental: Part 2: children (2-11 years)<br>Delgocitinib cream (dosage: B mg/g). | Drug: delgocitinib<br>* Cream for topical application<br>* Other names: LEO 124249;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (AEs) | Number of AEs and number of subjects with AEs | Week 0 to Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameter - Cmax | Cmax | at Day 8 | 
| PK parameter - AUC | AUC | at Day 8 | 
| PK parameter - tmax | tmax | at Day 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adults, pediatric