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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Clinical Disclosure; Phone Number: (+1) 877-557-1168; Email: clinicaltrialscontactus@leo-pharma.com

Study Locations

• Australia
  • Darlinghurst, Australia, 2010
    • Recruiting
    • LEO Pharma Investigational Site
  • Mitcham, Australia, 3132
    • Recruiting
    • LEO Pharma Investigational Site
  • Phillip, Australia, 2606
    • Recruiting
    • LEO Pharma Investigational Site
  • Woolloongabba, Australia, 4102
    • Recruiting
    • LEO Pharma Investigational Site
• Belgium
  • Brussels, Belgium, 1200
    • Recruiting
    • LEO Pharma Investigational Site
  • Gent, Belgium, 9000
    • Recruiting
    • LEO Pharma Investigational Site
  • Liège, Belgium, 4000
    • Recruiting
    • LEO Pharma Investigational Site
  • Loverval, Belgium, 6280
    • Recruiting
    • LEO Pharma Investigational Site
• Canada
  • Kingston, Canada, K7L 2V7
    • Recruiting
    • LEO Pharma Investigational Site
  • Montreal, Canada, H3T 1C5
    • Recruiting
    • LEO Pharma Investigational Site
  • Red Deer, Canada, T4P1K4
    • Recruiting
    • LEO Pharma Investigational Site
  • St. John's, Canada, NL A1E 1V4
    • Recruiting
    • LEO Pharma Investigational Site
  • Winnipeg, Canada, R3C 0N2
    • Recruiting
    • LEO Pharma Investigational Site
• France
  • Nice, France, 06000
    • Recruiting
    • LEO Pharma Investigational Site
  • Reims, France, 51100
    • Recruiting
    • LEO Pharma Investigational Site
  • Rouen, France, 76031
    • Recruiting
    • LEO Pharma Investigational Site
  • Toulouse Cedex 9, France, 31059
    • Recruiting
    • LEO Pharma Investigational Site
  • Bouches-du-Rhône
    • Martigues, Bouches-du-Rhône, France, 13500
      • Recruiting
      • LEO Pharma Investigational Site
• Poland
  • Chorzow, Poland, 41-516
    • Recruiting
    • LEO Pharma Investigational Site
  • Kraków, Poland, 30-033
    • Recruiting
    • LEO Pharma Investigational Site
  • Kraków, Poland, 31-011
    • Recruiting
    • LEO Pharma Investigational Site
  • Kraków, Poland, 31-147
    • Recruiting
    • LEO Pharma Investigational Site
  • Warszawa, Poland, 02-625
    • Recruiting
    • LEO Pharma Investigational Site
  • Wrocław, Poland, 51-318
    • Recruiting
    • LEO Pharma Investigational Site
• Spain
  • Alicante, Spain, 03010
    • Recruiting
    • LEO Pharma Investigational Site
  • Barcelona, Spain, 08041
    • Recruiting
    • LEO Pharma Investigational Site
  • Esplugues de Llobregat, Spain, 08950
    • Recruiting
    • LEO Pharma Investigational Site
  • Fuenlabrada, Spain, 28942
    • Recruiting
    • LEO Pharma Investigational Site
  • Granada, Spain, 18016
    • Recruiting
    • LEO Pharma Investigational Site
  • Pontevedra, Spain, 36001
    • Withdrawn
    • LEO Pharma Investigational Site
• United Kingdom
  • Ipswich, United Kingdom, IP4 5PD
    • Recruiting
    • LEO Pharma Investigational Site
  • King's Lynn, United Kingdom, PE30 4ET
    • Recruiting
    • LEO Pharma Investigational Site
  • Leytonstone, United Kingdom, E11 1NR
    • Recruiting
    • LEO Pharma Investigational Site
  • London, United Kingdom, SW10 9NH
    • Recruiting
    • LEO Pharma Investigational Site
  • Walsall, United Kingdom, WS2 9PS
    • Recruiting
    • 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:

• 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.

Study Plan

How is the study designed?

Design Details

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

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
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
HECSI-90 at Week 16	The Hand Eczema Severity Index (HECSI) is a scoring system to rate the severity of hand eczema. It gives a score from 0 (none) to 3 (severe) to 6 clinical signs of hand eczema: erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema over 5 regions of the hand - fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists. Each region is then assigned an area score from 0 (0%) to 4 (>75%) depending on how much is covered by lesions. For each region a region score is calculated by adding up the severity scores for the 6 clinical signs and multiplying with the area score. The HESCI score equals the sum of the 5 region scores and ranges from 0 to 360. HECSI-90 is at least 90% improvement in HECSI score from baseline	Week 16
Reduction of HESD itch score (weekly average) of ≥4 points from baseline at Week 16	The Hand Eczema Symptom Diary© (HESD) is an eDiary which patients use everyday to score the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours from 0 (none) to 10 (severe). This endpoint will only assess the 'itch' component for participants with a baseline HESD itch score (weekly average) of ≥4 points.	Week 16
Reduction of HESD pain score (weekly average) of ≥4 points from baseline at Week 16	The Hand Eczema Symptom Diary© (HESD) is an eDiary which patients use everyday to score the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours from 0 (none) to 10 (severe). This endpoint will only assess the 'pain' component for participants with a baseline HESD pain score (weekly average) of ≥4 points.	Week 16
Reduction of HESD score (weekly average) of ≥4 points from baseline at Week 16	The Hand Eczema Symptom Diary© (HESD) is an eDiary which patients use everyday to score the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours from 0 (none) to 10 (severe). 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
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
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
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
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
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).	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

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 (Estimated): December 3, 2024
• Study Completion (Estimated): 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): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Eczema
• Other Study ID Numbers: LP0133-1426; 2021-006340-27 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Access Criteria: Data sharing is subject to approved scientifically sound research proposal and signed data agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

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