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

Phase 1

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: delgocitinib

• Registration Number: NCT03826901
• Lead Sponsor: LEO Pharma

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

Study Timeline

• Study First Submitted: 2019-01-30
• Study First Submitted QC: 2019-01-31
• Study First Posted: 2019-02-01
• Study Start: 2019-02-20
• Primary Completion: 2021-10-29
• Study Completion: 2021-10-29
• Status Verified: 2021-11
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Part 1: adults and adolescents (12 years and above)	delgocitinib	Delgocitinib cream (dosage: A mg/g).
Part 2: children (2-11 years)	delgocitinib	Delgocitinib cream (dosage: B mg/g).

Primary Outcome Measures

Name	Time	Method
Adverse events (AEs)	Week 0 to Week 8	Number of AEs and number of subjects with AEs

Secondary Outcome Measures

Name	Time	Method
PK parameter - Cmax	at Day 8	Cmax
PK parameter - AUC	at Day 8	AUC
PK parameter - tmax	at Day 8	tmax

Trial Locations

Locations (1)

LEO Pharma investigational site; 🇨🇦 Montréal, Quebec, Canada