Atopic Dermatitis
Conditions
Keywords
adults, pediatric
Brief summary
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
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
Interventions
DRUGdelgocitinib
Cream for topical application
Sponsors
LEO Pharma
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (AEs) | Week 0 to Week 8 | Number of AEs and number of subjects with AEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK parameter - Cmax | at Day 8 | Cmax |
| PK parameter - AUC | at Day 8 | AUC |
| PK parameter - tmax | at Day 8 | tmax |
Countries
Canada, United States
Outcome results
None listed