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

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ClinicalTrials.gov Identifier: NCT03826901
Recruitment Status : Completed
First Posted : February 1, 2019
Last Update Posted : November 26, 2021
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Study Description
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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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: delgocitinib Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 20, 2019
Actual Primary Completion Date : October 29, 2021
Actual Study Completion Date : October 29, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arms and Interventions
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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 Name: LEO 124249
Experimental: Part 2: children (2-11 years)
Delgocitinib cream (dosage: B mg/g).
 Drug: delgocitinib
Cream for topical application
Other Name: LEO 124249


Outcome Measures
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Primary Outcome Measures :
  1. Adverse events (AEs) [ Time Frame: Week 0 to Week 8 ]
    Number of AEs and number of subjects with AEs


Secondary Outcome Measures :
  1. PK parameter - Cmax [ Time Frame: at Day 8 ]
    Cmax

  2. PK parameter - AUC [ Time Frame: at Day 8 ]
    AUC

  3. PK parameter - tmax [ Time Frame: at Day 8 ]
    tmax


Eligibility Criteria
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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826901


Locations
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United States, Alabama
LEO Pharma investigational site
Birmingham, Alabama, United States, 35209
United States, Arizona
LEO Pharma investigational site
Phoenix, Arizona, United States, 85006
United States, California
LEO Pharma investigational site
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
United States, Colorado
LEO Pharma investigational site
Centennial, Colorado, United States, 80112
United States, Connecticut
LEO Pharma investigational site
New Haven, Connecticut, United States, 06519
United States, Indiana
LEO Pharma investigational site
Indianapolis, Indiana, United States, 46250
United States, Michigan
LEO Pharma investigational site
Ypsilanti, Michigan, United States, 48197
United States, Oklahoma
LEO Pharma investigational site
Tulsa, Oklahoma, United States, 74136
United States, Oregon
LEO Pharma investigational site
Medford, Oregon, United States, 97504
United States, Texas
LEO Pharma investigational site
San Antonio, Texas, United States, 78218
Canada, Alberta
LEO Pharma investigational site
Red Deer, Alberta, Canada, 46-37535
Canada, Ontario
LEO Pharma investigational site
Hamilton, Ontario, Canada, L8S 1G5
Canada, Quebec
LEO Pharma investigational site
Montreal, Quebec, Canada, H3T 1C5
LEO Pharma investigational site
Montréal, Quebec, Canada, H2K 4L5
Sponsors and Collaborators
LEO Pharma
Investigators
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Study Director: Medical Expert LEO Pharma
More Information
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT03826901    
Other Study ID Numbers: LP0133-1181
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: November 26, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data is available to request after approval of the studied indication.
URL: http://leopharmatrials.com/for-professionals

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by LEO Pharma:
adults, pediatric
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases