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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03826901
• Other study ID #: LP0133-1181
• Status: Completed
• Phase: Phase 1
• Start date: February 20, 2019
• Est. completion date: October 29, 2021

Study information

• Verified date: November 2021
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 29, 2021
• Est. primary completion date: October 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• delgocitinib
Cream for topical application

Locations

Country	Name	City	State
Canada	LEO Pharma investigational site	Hamilton	Ontario
Canada	LEO Pharma investigational site	Montreal	Quebec
Canada	LEO Pharma investigational site	Montréal	Quebec
Canada	LEO Pharma investigational site	Red Deer	Alberta
United States	LEO Pharma investigational site	Birmingham	Alabama
United States	LEO Pharma investigational site	Centennial	Colorado
United States	LEO Pharma investigational site	Fountain Valley	California
United States	LEO Pharma investigational site	Indianapolis	Indiana
United States	LEO Pharma investigational site	Irvine	California
United States	LEO Pharma investigational site	Los Angeles	California
United States	LEO Pharma investigational site	Medford	Oregon
United States	LEO Pharma investigational site	New Haven	Connecticut
United States	LEO Pharma investigational site	Phoenix	Arizona
United States	LEO Pharma investigational site	San Antonio	Texas
United States	LEO Pharma investigational site	Tulsa	Oklahoma
United States	LEO Pharma investigational site	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events (AEs)	Number of AEs and number of subjects with AEs	Week 0 to Week 8
Secondary	PK parameter - Cmax	Cmax	at Day 8
Secondary	PK parameter - AUC	AUC	at Day 8
Secondary	PK parameter - tmax	tmax	at Day 8