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

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 (DELTA TEEN)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Hand Eczema
• Intervention / Treatment: Drug: Delgocitinib; Drug: Cream vehicle

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Darlinghurst, Australia, 2010
    • LEO Pharma Investigational Site
  • Mitcham, Australia, 3132
    • LEO Pharma Investigational Site
  • Phillip, Australia, 2606
    • LEO Pharma Investigational Site
  • Woolloongabba, Australia, 4102
    • LEO Pharma Investigational Site
• Belgium
  • Brussels, Belgium, 1200
    • LEO Pharma Investigational Site
  • Ghent, Belgium, 9000
    • LEO Pharma Investigational Site
  • Gilly, Belgium, 6060
    • LEO Pharma Investigational Site
  • Liège, Belgium, 4000
    • LEO Pharma Investigational Site
• Canada
  • Edmonton, Canada, T6G 1C3
    • LEO Pharma Investigational Site
  • Fredericton, Canada, E3B 1G9
    • LEO Pharma Investigational Site
  • Kingston, Canada, K7L 2V7
    • LEO Pharma Investigational Site
  • Montreal, Canada, H3T 1C5
    • LEO Pharma Investigational Site
  • Red Deer, Canada, T4P1K4
    • LEO Pharma Investigational Site
  • St. John's, Canada, NL A1E 1V4
    • LEO Pharma Investigational Site
  • Toronto, Canada, M2N 3A6
    • LEO Pharma Investigational Site
  • Winnipeg, Canada, R3C 0N2
    • LEO Pharma Investigational Site
• France
  • Nice, France, 06000
    • LEO Pharma Investigational Site
  • Reims, France, 51100
    • LEO Pharma Investigational Site
  • Toulouse, France, 31059
    • LEO Pharma Investigational Site
  • Bouches-du-Rhône
    • Martigues, Bouches-du-Rhône, France, 13500
      • LEO Pharma Investigational Site
• Poland
  • Chorzów, Poland, 41-516
    • LEO Pharma Investigational Site
  • Krakow, Poland, 30-033
    • LEO Pharma Investigational Site
  • Krakow, Poland, 31-011
    • LEO Pharma Investigational Site
  • Krakow, Poland, 30-002
    • LEO Pharma Investigational Site
  • Warsaw, Poland, 02-625
    • LEO Pharma Investigational Site
  • Wroclaw, Poland, 51-503
    • LEO Pharma Investigational Site
• Spain
  • Alicante, Spain, 03010
    • LEO Pharma Investigational Site
  • Barcelona, Spain, 08041
    • LEO Pharma Investigational Site
  • Cadiz, Spain, 11009
    • LEO Pharma Investigational Site
  • Esplugues de Llobregat, Spain, 08950
    • LEO Pharma Investigational Site
  • Fuenlabrada, Spain, 28942
    • LEO Pharma Investigational Site
  • Granada, Spain, 18016
    • LEO Pharma Investigational Site
• United Kingdom
  • Ipswich, United Kingdom, IP4 5PD
    • LEO Pharma Investigational Site
  • Kings Lynn, United Kingdom, PE30 4ET
    • LEO Pharma Investigational Site
  • Lincoln, United Kingdom, LN2 5QY
    • LEO Pharma Investigational Site
  • London, United Kingdom, SW10 9NH
    • LEO Pharma Investigational Site
  • Walsall, United Kingdom, WS2 9PS
    • LEO Pharma Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Delgocitinib cream; Delgocitinib cream 20 mg/g twice daily	Drug: Delgocitinib; Cream for topical application
Placebo Comparator: Cream vehicle; Cream vehicle twice daily	Drug: Cream vehicle; The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With IGA-CHE Treatment Success at Week 16	The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline.	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in CDLQI Score From Baseline to Week 16	The Children's Dermatology Life Quality Index (CDLQI) is a validated questionnaire consisting of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their quality of life over the last week. Each question is scored from 0 (no impact) to 3 (high impact). The CDLQI score is the sum of the 10 items (score ranging from 0 to 30); a high score is indicative of a poor quality of life.	Week 16
Number of Treatment Emergent AEs From Baseline up to Week 18	An adverse event (AE) will be considered treatment emergent if started after the first application of treatment, or started before the first application of treatment and worsened in severity after treatment.	Week 18
Number of Participants With HECSI-90 at Week 16	The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score), with a higher score indicating greater severity. HECSI-90 is defined as at least 90% improvement in HECSI score from baseline.	Week 16
Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 16	The Hand Eczema Symptom Diary© (HESD) is an instrument designed to assess severity of CHE signs and symptoms. The participants will assess the worst severity of 6 individual signs and symptoms of CHE from 0 (none) to 10 (severe) over the past 24 hours. The participants will complete the HESD on a daily basis in an eDiary.' This endpoint will only assess the 'itch' component for participants with a baseline HESD itch score (weekly average) of ≥4 points.	Week 16
Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 16	The Hand Eczema Symptom Diary© (HESD) is an instrument designed to assess severity of CHE signs and symptoms. The participants will assess the worst severity of 6 individual signs and symptoms of CHE from 0 (none) to 10 (severe) over the past 24 hours. The participants will complete the HESD on a daily basis in an eDiary.' This endpoint will only assess the 'pain' component for participants with a baseline HESD pain score (weekly average) of ≥4 points.	Week 16
Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 16	The Hand Eczema Symptom Diary© (HESD) is an instrument designed to assess severity of CHE signs and symptoms. The participants will assess the worst severity of 6 individual signs and symptoms of CHE from 0 (none) to 10 (severe) over the past 24 hours. The participants will complete the HESD on a daily basis in an eDiary.' The final HESD score is an average of these 6 individual scores. This endpoint will only assess the score for participants with a baseline HESD itch score (weekly average) of ≥4 points.	Week 16
Number of Participants With IGA-CHE Treatment Success at Week 2	The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline.	Week 2
Number of Participants With IGA-CHE Treatment Success at Week 4	The Investigator's Global Assessment for chronic hand eczema© (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline.	Week 4
Number of Participants With IGA-CHE Treatment Success at Week 8	The Investigator's Global Assessment for chronic hand eczema© (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline.	Week 8
Number of Participants With IGA-CHE Treatment Success at Week 12	The Investigator's Global Assessment for chronic hand eczema© (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline.	Week 12

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Study Director: Medical Expert, LEO Pharma

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2022
• Primary Completion (Actual): December 5, 2024
• Study Completion (Actual): December 17, 2024

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Eczematous; Dermatitis; Eczema; delgocitinib
• Other Study ID Numbers: LP0133-1426; 2021-006340-27 (EudraCT Number); U1111-1284-2122 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Sharing Access Criteria: De-identified Individual Participant Data can be made available to researchers and is subject to approved scientifically sound research proposal and signed data-sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No