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: 2025-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-14
• Study Completion Date: 2024-12-17

Brief Summary

The purpose of this trial is to test if delgocitinib cream is effective in treating chronic hand eczema (CHE) and to find out what side effects it may have compared with a cream vehicle with no active medical ingredient in adolescents aged 12-17 years. At each visit to the clinic, the doctor will assess the severity and extent of CHE, and during the trial, the adolescents will assess their CHE signs and symptoms as well as quality of life.

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 adolescent participant will use either the delgocitinib cream or cream vehicle twice daily.

Conditions

Chronic Hand Eczema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Delgocitinib cream

Delgocitinib cream 20 mg/g twice daily

Group Type: EXPERIMENTAL

Delgocitinib

Intervention Type: DRUG

Cream for topical application

Cream vehicle

Cream vehicle twice daily

Group Type: PLACEBO_COMPARATOR

Cream vehicle

Intervention Type: DRUG

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

Interventions

Delgocitinib

Cream for topical application

Intervention Type: DRUG

Cream vehicle

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age 12 to 17 years at screening and baseline.
• 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 (i.e. an IGA-CHE score of 3 or 4).
• Subjects who have a documented recent history of inadequate response to treatment with topical corticosteroids (TCS) (at any time within 1 year before the screening visit) or for whom TCS are documented to be otherwise medically inadvisable (e.g. due to important side effects or safety risks).

• Inadequate response is defined as a history of failure to achieve and maintain a low disease activity state (comparable to an IGA-CHE score of ≤2) despite treatment with a daily regimen of TCS of class III-IV (potent to very potent) for Europe and Australia and class IV-I (medium potency to very/ultra-high potency) for Canada, applied for at least 28 days or for the maximum duration recommended by the product prescribing information, whichever is shorter.
• Important side effects or safety risks are those that outweigh the potential treatment benefits and include intolerance to treatment, hypersensitivity reactions, and significant skin atrophy as assessed by the physician.

Exclusion Criteria

• Concurrent skin diseases on the hands, e.g. tinea manuum.
• Clinically significant infection (e.g. impetiginised hand eczema) on the hands.
• Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), immunomodulating drugs, retinoids (e.g. alitretinoin), 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 (e.g. ultraviolet B (UVB), ultraviolet A1 (UVA1), psoralen ultraviolet A (PUVA)), 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 (e.g. PDE-4 inhibitors, pimecrolimus, tacrolimus) 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. Examples include but are not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, immunological, and psychiatric disorders, and major physical impairment.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Expert

Role: STUDY_DIRECTOR

LEO Pharma

Locations

LEO Pharma investigational site

Darlinghurst, , Australia

LEO Pharma investigational site

Mitcham, , Australia

LEO Pharma investigational site

Phillip, , Australia

LEO Pharma investigational site

Woolloongabba, , Australia

LEO Pharma investigational site

Brussels, , Belgium

LEO Pharma investigational site

Ghent, , Belgium

LEO Pharma investigational site

Gilly, , Belgium

LEO Pharma investigational site

Liège, , Belgium

LEO Pharma investigational site

Edmonton, , Canada

LEO Pharma investigational site

Fredericton, , Canada

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

Toronto, , Canada

LEO Pharma investigational site

Winnipeg, , Canada

LEO Pharma investigational site

Martigues, Bouches-du-Rhône, France

LEO Pharma investigational site

Nice, , France

LEO Pharma investigational site

Reims, , France

LEO Pharma investigational site

Toulouse, , France

LEO Pharma investigational site

Chorzów, , Poland

LEO Pharma investigational site

Krakow, , Poland

LEO Pharma investigational site

Krakow, , Poland

LEO Pharma investigational site

Krakow, , Poland

LEO Pharma investigational site

Warsaw, , Poland

LEO Pharma investigational site

Wroclaw, , Poland

LEO Pharma investigational site

Alicante, , Spain

LEO Pharma investigational site

Barcelona, , Spain

LEO Pharma investigational site

Cadiz, , 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

Ipswich, , United Kingdom

LEO Pharma investigational site

Kings Lynn, , United Kingdom

LEO Pharma investigational site

Lincoln, , United Kingdom

LEO Pharma investigational site

London, , United Kingdom

LEO Pharma investigational site

Walsall, , United Kingdom

Countries

Australia; Belgium; Canada; France; Poland; Spain; United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2021-006340-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1284-2122

Identifier Type: OTHER

Identifier Source: secondary_id

LP0133-1426

Identifier Type: -

Identifier Source: org_study_id