Delgocitinib for Eczema

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
LEO Pharma investigational site, Red Deer, Canada
Eczema+1 More
Delgocitinib - Drug
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing if delgocitinib cream is effective at treating chronic hand eczema in children aged 12-17. There will be a range of assessments that rate the severity and extent of CHE symptoms, general health and quality of life. Delgocitinib is approved by the FDA to treat eczema. This medication was previously approved to treat a different condition.

Eligible Conditions

  • Eczema

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: Week 18

Week 12
IGA-CHE treatment success at Week 12
Week 16
Change in cDLQI score from baseline to Week 16
HECSI-90 at Week 16
IGA-CHE treatment success at Week 16
Reduction of HESD itch score (weekly average) of ≥4 points from baseline at Week 16
Reduction of HESD pain score (weekly average) of ≥4 points from baseline at Week 16
Reduction of HESD score (weekly average) of ≥4 points from baseline at Week 16
Week 18
Number of treatment emergent AEs from baseline up to Week 18
Week 2
IGA-CHE treatment success at Week 2
Week 4
IGA-CHE treatment success at Week 4
Week 8
IGA-CHE treatment success at Week 8

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Delgocitinib cream
1 of 2
Cream vehicle
1 of 2
Experimental Treatment
Non-Treatment Group

92 Total Participants · 2 Treatment Groups

Primary Treatment: Delgocitinib · Has Placebo Group · Phase 3

Delgocitinib cream
Drug
Experimental Group · 1 Intervention: Delgocitinib · Intervention Types: Drug
Cream vehicle
Drug
PlaceboComparator Group · 1 Intervention: Cream vehicle · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 18
Closest Location: LEO Pharma investigational site · Red Deer, Canada
2021First Recorded Clinical Trial
4 TrialsResearching Eczema
3 CompletedClinical Trials

Who is running the clinical trial?

LEO PharmaLead Sponsor
258 Previous Clinical Trials
181,396 Total Patients Enrolled
38 Trials studying Eczema
17,720 Patients Enrolled for Eczema
Medical ExpertStudy DirectorLEO Pharma
47 Previous Clinical Trials
8,087 Total Patients Enrolled
17 Trials studying Eczema
3,682 Patients Enrolled for Eczema

Eligibility Criteria

Age < 18 · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have hand eczema that has persisted for more than 3 months or returned twice or more within the last 12 months.
You have moderate to severe disease at baseline.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.