Delgocitinib cream for the treatment of moderate to severe AD during 8 weeks in adults, adolescents, and children.
- Conditions
- Atopic Dermatitis (AD)Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2021-000404-37-Outside-EU/EEA
- Lead Sponsor
- EO Pharma A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- Not specified
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
Are the trial subjects under 18? yes
Number of subjects for this age range: 32
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method