Clinical Trial Details for

Efficacy and Safety of Delgocitinib Cream in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema

NCT ID: NCT05355818

Last Updated: July 05, 2023

Official Title

A Phase 3 Clinical Trial to Evaluate Efficacy and Safety of Twice-daily Applications of Delgocitinib Cream 20 mg/g Compared With Cream Vehicle for a 16-week Treatment Period in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema

Purpose

The purpose of this trial is to test if delgocitinib cream is effective at treating chronic hand eczema (CHE) and what side effects it may have, 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 a cream that suppresses specific processes in the body's response to diseases like CHE, such as inflammation. The trial will last up to 22 weeks and has a 1-4 week screening period, a 16 week treatment period and a 2 week follow up period. During the treatment period each child will use either delgocitinib cream or a cream vehicle twice a day. Which cream each child receives is chosen randomly by a computer. The cream vehicle is made of the same ingredients as the delgocitinib cream except for the active medical ingredient. There will be 8 visits with the trial doctor.

The Study at a Glance

Status: RECRUITING

Phase: Phase 3

Gender: ALL

Age: 12 Years - 17 Years

Condition: Chronic Hand Eczema

Study Type: Interventional

Lead Sponsor: LEO Pharma

Eligibility

Ages Eligible for Study: 12 Years to 17 Years

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

Inclusion Criteria: * Diagnosis of CHE, defined as hand eczema that has persisted for more than 3 months or returned twice or more within the last 12 months. * Disease severity graded as moderate to severe at screening and baseline according to IGA-CHE. * Subjects who have a documented history of inadequate response to treatment with TCS or for whom TCS are documented to be otherwise medically inadvisable. Exclusion Criteria: * Concurrent skin disease on the hands. * Clinically significant infection on the hands. * Systemic treatment with immunosuppressive drugs, immunomodulating drugs, retinoids, or corticosteroids within 28 days prior to baseline (steroid eyedrops and inhaled or intranasal steroids corresponding to up to 1 mg prednisolone for allergic conjunctivitis, asthma, or rhinitis are allowed). * Use of tanning beds, phototherapy, or bleach baths on the hands within 28 days prior to baseline. * Previous or current treatment with JAK inhibitors (including delgocitinib/LEO 124249), systemic or topical. * Cutaneously applied treatment with immunomodulators or TCS on the hands within 14 days prior to baseline. * Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 14 days prior to baseline. * Other cutaneously applied therapy on the hands (except for the use of subject's own emollients) within 7 days 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 7 days prior to baseline. * Any disorder which is not stable and could: * Affect the safety of the subject throughout the trial. * Impede the subject's ability to complete the trial.

Additional Information, Locations & Contacts

Collaborators: Not provided

Investigators: Medical Expert

Please refer to this study by its clinicaltrials.gov identifier: NCT05355818
Location

LEO Pharma investigational site

Darlinghurst, Australia

LEO Pharma investigational site

Phillip, Australia

LEO Pharma investigational site

Woolloongabba, Australia

LEO Pharma investigational site

Brussels, Belgium

LEO Pharma investigational site

Gent, Belgium

LEO Pharma investigational site

Liège, Belgium

LEO Pharma investigational site

Loverval, Belgium

LEO Pharma investigational site

Kingston, Canada

LEO Pharma investigational site

Montreal, Canada

LEO Pharma investigational site

Red Deer, Canada

LEO Pharma investigational site

St. John's, Canada

LEO Pharma investigational site

Winnipeg, Canada

LEO Pharma investigational site

Nice, France

LEO Pharma investigational site

Reims, France

LEO Pharma investigational site

Rouen, France

LEO Pharma investigational site

Toulouse Cedex 9, France

LEO Pharma investigational site

Chorzow, Poland

LEO Pharma investigational site

Kraków, Poland

LEO Pharma investigational site

Kraków, Poland

LEO Pharma investigational site

Kraków, Poland

LEO Pharma investigational site

Warszawa, Poland

LEO Pharma investigational site

Wrocław, Poland

LEO Pharma investigational site

Alicante, Spain

LEO Pharma investigational site

Barcelona, Spain

LEO Pharma investigational site

Esplugues de Llobregat, Spain

LEO Pharma investigational site

Fuenlabrada, Spain

LEO Pharma investigational site

Granada, Spain

LEO Pharma investigational site

Pontevedra, Spain

LEO Pharma investigational site

Ipswich, United Kingdom

LEO Pharma investigational site

King's Lynn, United Kingdom

LEO Pharma investigational site

Leytonstone, United Kingdom

LEO Pharma investigational site

Walsall, United Kingdom

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