NCT03826901|CompletedPhase 1FDA Drug

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

LEO Pharma ClinicalTrials.gov

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1 other identifier

LP0133-1181

Study Type

interventional

Target

Locations

2 countries

Sites

Timeline

RegisteredFeb 2019

StartedFeb 2019

CompletionOct 2021

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_1

Timeline

Completed

Started Feb 2019

Typical duration for phase_1

Geographic Reach

2 countries

16 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.7 years study duration

First Submitted

Initial submission to the registry

January 30, 2019

Completed

2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed

19 days until next milestone

Study Start

First participant enrolled

February 20, 2019

Completed

2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2021

Completed

Last Updated

February 24, 2025

Status Verified

November 1, 2021

Enrollment Period

2.7 years

First QC Date

January 30, 2019

Last Update Submit

February 21, 2025

Conditions

Atopic Dermatitis

Keywords

adults, pediatric

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

PK parameter - Cmax
at Day 8
PK parameter - AUC
at Day 8
PK parameter - tmax
at Day 8

Study Arms (2)

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

delgocitinibDRUG

Cream for topical application

Also known as: LEO 124249

Part 1: adults and adolescents (12 years and above)Part 2: children (2-11 years)

Eligibility Criteria

Age2 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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
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

You may not qualify if:

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

Contact the study team to confirm eligibility.