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Janus Kinase (JAK) Inhibitor
Delgocitinib cream for Eczema (DELTA 2 Trial)
Phase 3
Waitlist Available
Research Sponsored by LEO Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks (18 weeks for participants not participating in the long-term extension trial [lp0133-1403])
Awards & highlights
Pivotal Trial
Summary
This trial is testing a special cream called delgocitinib to see if it can help adults with chronic hand eczema. The cream aims to reduce inflammation and ease symptoms like itching and pain.
Eligible Conditions
- Eczema
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks (18 weeks for participants not participating in the long-term extension trial [lp0133-1403])
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks (18 weeks for participants not participating in the long-term extension trial [lp0133-1403])
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With IGA-CHE TS at Week 16
Secondary study objectives
Change in DLQI Score From Baseline to Week 16
Change in HEIS PDAL Score From Baseline to Week 16
Change in HEIS Score From Baseline to Week 16
+21 moreSide effects data
From 2022 Phase 3 trial • 487 Patients • NCT0487171111%
COVID-19
7%
Nasopharyngitis
3%
Headache
2%
Allergy to metals
1%
Dermatitis contact
100%
80%
60%
40%
20%
0%
Study treatment Arm
Delgocitinib |20 mg/g
Vehicle|
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Delgocitinib cream 20 mg/gExperimental Treatment1 Intervention
Twice-daily topical application for 16 weeks
Group II: Cream vehiclePlacebo Group1 Intervention
Twice-daily topical application for 16 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Delgocitinib cream
2018
Completed Phase 3
~1600
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Who is running the clinical trial?
LEO PharmaLead Sponsor
270 Previous Clinical Trials
188,190 Total Patients Enrolled
45 Trials studying Eczema
19,779 Patients Enrolled for Eczema
Medical ExpertStudy DirectorLEO Pharma
55 Previous Clinical Trials
9,838 Total Patients Enrolled
21 Trials studying Eczema
4,729 Patients Enrolled for Eczema
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