NCT03683719|CompletedPhase 2ResultsFDA Drug

Phase 2b Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over a 16-week Treatment Period in Adult Subjects With Chronic Hand Eczema

A Phase 2b, Double-blind, Randomised, 5-arm, Vehicle-controlled, Dose-ranging Trial to Evaluate the Efficacy and Safety of Twice Daily Topical Application of Delgocitinib Cream 1, 3, 8, and 20 mg/g for 16 Weeks in Adult Subjects With Mild to Severe Chronic Hand Eczema

LEO Pharma ClinicalTrials.gov

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1 other identifier

LP0133-1273

Study Type

interventional

Target

258

Locations

3 countries

Sites

Timeline

RegisteredSep 2018

StartedNov 2018

CompletionApr 2020

Brief Summary

The purpose of this research trial was to test different strengths of a new trial medication, delgocitinib cream 1, 3, 8, and 20 mg/g, and to investigate how treatment with delgocitinib cream affects chronic hand eczema. This was judged by a range of assessments that rate the severity and extent of chronic hand eczema and its symptoms, as well as general health status and quality of life.

Trial Health

On Track

Trial Health Score

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

Enrollment

258

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Nov 2018

Shorter than P25 for phase_2

Geographic Reach

3 countries

28 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

1.4 years study duration

First Submitted

Initial submission to the registry

September 21, 2018

Completed

4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed

2 months until next milestone

Study Start

First participant enrolled

November 28, 2018

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2020

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2020

Completed

12 months until next milestone

Results Posted

Study results publicly available

April 19, 2021

Completed

Last Updated

March 12, 2025

Status Verified

April 1, 2021

Enrollment Period

1.3 years

First QC Date

September 21, 2018

Results QC Date

March 23, 2021

Last Update Submit

February 21, 2025

Conditions

Chronic Hand Eczema

Outcome Measures

Primary Outcomes (1)

Investigator's Global Assessment for Chronic Hand Eczema (IGA-CHE) Score of 0 (Clear) or 1 (Almost Clear) With at Least a 2-step Improvement (IGA-CHE Treatment Success) From Baseline to Week 16.
IGA-CHE is an instrument used in clinical trials to rate the severity of subject's global disease stage and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). The multiple comparison procedure - modelling (MCP-Mod) approach was used to guide dose selection. Cochran-Mantel-Haenszel analysis was used to determine the difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle.
Week 0 to Week 16.

Secondary Outcomes (2)

Change in Hand Eczema Severity Index (HECSI) From Baseline to Week 16.
Week 0 to Week 16.
Time to IGA-CHE Treatment Success.
Week 0 to Week 16.

Study Arms (5)

Delgocitinib cream 1 mg/g

EXPERIMENTAL

Delgocitinib cream applied twice daily for 16 weeks.

Drug: Delgocitinib cream

Delgocitinib cream 3 mg/g

EXPERIMENTAL

Delgocitinib cream applied twice daily for 16 weeks.

Drug: Delgocitinib cream

Delgocitinib cream 8 mg/g

EXPERIMENTAL

Delgocitinib cream applied twice daily for 16 weeks.

Drug: Delgocitinib cream

Delgocitinib cream 20 mg/g

EXPERIMENTAL

Delgocitinib cream applied twice daily for 16 weeks.

Drug: Delgocitinib cream

Delgocitinib cream vehicle

PLACEBO COMPARATOR

Delgocitinib cream vehicle applied twice daily for 16 weeks.

Drug: Delgocitinib cream vehicle

Interventions

Delgocitinib creamDRUG

Cream for topical application.

Also known as: LEO 124249 cream

Delgocitinib cream 1 mg/gDelgocitinib cream 20 mg/gDelgocitinib cream 3 mg/gDelgocitinib cream 8 mg/g

Delgocitinib cream vehicleDRUG

The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.

Also known as: LEO 124249 cream vehicle

Delgocitinib cream vehicle

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age 18 years or above.
Diagnosis of chronic hand eczema defined as hand eczema, which has persisted for more than 3 months or returned twice or more within the last 12 months.
Disease severity graded as mild to severe according to IGA (i.e., IGA ≥2).
Recent history (within 1 year before the screening visit) of inadequate response to topical corticosteroid treatment or topical corticosteroid treatment being medically inadvisable.
Diagnostic patch testing performed within 3 years prior to the screening visit.

You may not qualify if:

Concurrent skin diseases on the hands e.g tinnea manuum.
Active atopic dermatitis in regions other than the hands or psoriasis requiring medical treatment.
Clinically significant infection (e.g., impetiginised hand eczema) on the hands.
Systemic treatment with immunosuppressive drugs, immunomodulating drugs, retinoids, or corticosteroids within 4 weeks prior to baseline.
Psoralen ultraviolet A (PUVA) or ultraviolet B (UVB) therapy on the hands within 4 weeks prior to baseline.
Receipt of live attenuated vaccines 4 weeks prior to baseline.
Cutaneously applied treatment with immunomodulators (e.g., phosphodiesterase-4 (PDE-4) inhibitors, pimecrolimus, tacrolimus) or topical corticosteroids on the hands within 2 weeks prior to baseline.
Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 2 weeks prior to baseline.
Change in systemic antihistamine therapy within 2 weeks prior to baseline i.e., subjects must not start antihistamine treatment or change the current dosage regime within 2 weeks prior to baseline.
Other cutaneously applied therapy on the hands (except for the use of subject's own emollients) within 1 week prior to baseline.
Cutaneously applied treatments in regions other than the hands, which could interfere with clinical trial evaluations or pose a safety concern within 1 week prior to baseline.
Receipt of any marketed or investigational biologic agents within 6 months or 5 half-lives prior to baseline or until cells count returns to normal, whichever is longer.
Clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to baseline.
Tuberculosis requiring treatment within 12 months prior to screening and/or subjects with a positive blood test for tuberculosis at screening.
History of any known primary immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test at screening, or the subject taking antiretroviral medications.
+2 more criteria

Contact the study team to confirm eligibility.