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

LEO Pharma

Status and phase

Completed

Phase 1

Conditions

Atopic Dermatitis

Treatments

Drug: delgocitinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT03826901

LP0133-1181

Details and patient eligibility

About

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.

Full 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

Enrollment

46 patients

Sex

All

Ages

2+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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