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

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

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: delgocitinib

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 Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Red Deer, Alberta, Canada, 46-37535
      • LEO Pharma Investigational Site
  • Ontario
    • Hamilton, Ontario, Canada, L8S 1G5
      • LEO Pharma Investigational Site
  • Quebec
    • Montreal, Quebec, Canada, H3T 1C5
      • LEO Pharma Investigational Site
    • Montréal, Quebec, Canada, H2K 4L5
      • LEO Pharma Investigational Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • LEO Pharma Investigational Site
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • LEO Pharma Investigational Site
  • California
    • Fountain Valley, California, United States, 92708
      • LEO Pharma Investigational Site
    • Irvine, California, United States, 92697
      • LEO Pharma Investigational Site
    • Los Angeles, California, United States, 90027
      • LEO Pharma Investigational Site
  • Colorado
    • Centennial, Colorado, United States, 80112
      • LEO Pharma Investigational Site
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • LEO Pharma Investigational Site
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • LEO Pharma Investigational Site
  • Michigan
    • Ypsilanti, Michigan, United States, 48197
      • LEO Pharma Investigational Site
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • LEO Pharma Investigational Site
  • Oregon
    • Medford, Oregon, United States, 97504
      • LEO Pharma Investigational Site
  • Texas
    • San Antonio, Texas, United States, 78218
      • LEO Pharma Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: adults and adolescents (12 years and above); Delgocitinib cream (dosage: A mg/g).	Drug: delgocitinib; Cream for topical application; Other Names: LEO 124249
Experimental: Part 2: children (2-11 years); Delgocitinib cream (dosage: B mg/g).	Drug: delgocitinib; Cream for topical application; Other Names: LEO 124249

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events (AEs)	Number of AEs and number of subjects with AEs	Week 0 to Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameter - Cmax	Cmax	at Day 8
PK parameter - AUC	AUC	at Day 8
PK parameter - tmax	tmax	at Day 8

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Study Director: Medical Expert, LEO Pharma

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2019
• Primary Completion (Actual): October 29, 2021
• Study Completion (Actual): October 29, 2021

Study Registration Dates

• First Submitted: January 30, 2019
• First Submitted That Met QC Criteria: January 31, 2019
• First Posted (Actual): February 1, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: adults, pediatric
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis, Atopic; Dermatitis; Eczema
• Other Study ID Numbers: LP0133-1181

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

De-identified IPD can be made available to researchers in a closed environment for a specified period of time.

Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.

• IPD Sharing Time Frame: Data is available to request after approval of the studied indication.
• IPD Sharing Access Criteria: De-identified Individual Participant Data can be made available to researchers and is subject to approved scientifically sound research proposal and signed data-sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No