Status:
COMPLETED
Delgocitinib Cream for the Treatment of Moderate to Severe Atopic Dermatitis During 8 Weeks in Adults, Adolescents, and Children
Lead Sponsor:
LEO Pharma
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
2+ years
Phase:
PHASE1
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 a...
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, adoles...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 29 2021
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03826901
Start Date
February 20 2019
End Date
October 29 2021
Last Update
February 24 2025
Active Locations (16)
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1
LEO Pharma investigational site
Birmingham, Alabama, United States, 35209
2
LEO Pharma investigational site
Phoenix, Arizona, United States, 85006
3
LEO Pharma investigational site
Fountain Valley, California, United States, 92708
4
LEO Pharma investigational site
Irvine, California, United States, 92697