Delgocitinib Cream for the Treatment of Moderate to Sever... | NCT03826901

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 20, 2019Actual

Primary Completion Date

Oct 29, 2021Actual

Completion Date

Oct 29, 2021Actual

First Submitted Date

Jan 30, 2019

First Submission Date that Met QC Criteria

Jan 31, 2019

First Posted Date

Feb 1, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2025

Last Update Posted Date

Feb 24, 2025Actual

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
delgocitinib	Drug	Cream for topical application	Part 1: adults and adolescents (12 years and above) Part 2: children (2-11 years)

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

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

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Expert	LEO Pharma	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
LEO Pharma investigational site		Birmingham	Alabama	35209	United States
LEO Pharma investigational site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42143645	Derived	Gooderham M, Bunick CG, Yu J, Maslin D, Schneider SKR, Osterdal ML, Sohoel A, Madsen DE, Eichenfield LF. Minimal Systemic Exposure with Maximal Delgocitinib Cream Use in Patients with Severe Chronic Hand Eczema in the DELTA 2 Randomized, Vehicle-Controlled, Double-Blind, Phase 3 Trial. Dermatol Ther (Heidelb). 2026 Jul;16(7):3275-3283. doi: 10.1007/s13555-026-01767-1. Epub 2026 May 17.

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D017443	Skin Diseases, Eczematous
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases