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

• ClinicalTrials.gov Identifier: NCT05355818
• Recruitment Status: Recruiting
• First Posted: May 2, 2022
• Last Update Posted: April 9, 2024
• Sponsor: LEO Pharma
• Information provided by (Responsible Party): LEO Pharma

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Chronic Hand Eczema	Drug: Delgocitinib; Drug: Cream vehicle	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 92 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: July 14, 2022
• Estimated Primary Completion Date: December 3, 2024
• Estimated Study Completion Date: December 17, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. IGA-CHE treatment success at Week 16 [ Time Frame: 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.

Secondary Outcome Measures :

1. HECSI-90 at Week 16 [ Time Frame: 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
2. Reduction of HESD itch score (weekly average) of ≥4 points from baseline at Week 16 [ Time Frame: 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.
3. Reduction of HESD pain score (weekly average) of ≥4 points from baseline at Week 16 [ Time Frame: 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.
4. Reduction of HESD score (weekly average) of ≥4 points from baseline at Week 16 [ Time Frame: 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.
5. IGA-CHE treatment success at Week 2 [ Time Frame: 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.
6. IGA-CHE treatment success at Week 4 [ Time Frame: 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.
7. IGA-CHE treatment success at Week 8 [ Time Frame: 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.
8. IGA-CHE treatment success at Week 12 [ Time Frame: 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.
9. Change in cDLQI score from baseline to Week 16 [ Time Frame: 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).
10. Number of treatment emergent AEs from baseline up to Week 18 [ Time Frame: 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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Contacts

Contact: Clinical Disclosure; (+1) 877-557-1168; clinicaltrialscontactus@leo-pharma.com

Locations

Australia

LEO Pharma investigational site; Recruiting

Darlinghurst, Australia, 2010

LEO Pharma investigational site; Recruiting

Mitcham, Australia, 3132

LEO Pharma investigational site; Recruiting

Phillip, Australia, 2606

LEO Pharma investigational site; Recruiting

Woolloongabba, Australia, 4102

Belgium

LEO Pharma investigational site; Recruiting

Brussels, Belgium, 1200

LEO Pharma investigational site; Recruiting

Gent, Belgium, 9000

LEO Pharma investigational site; Recruiting

Liège, Belgium, 4000

LEO Pharma investigational site; Recruiting

Loverval, Belgium, 6280

Canada

LEO Pharma investigational site; Recruiting

Kingston, Canada, K7L 2V7

LEO Pharma investigational site; Recruiting

Montreal, Canada, H3T 1C5

LEO Pharma investigational site; Recruiting

Red Deer, Canada, T4P1K4

LEO Pharma investigational site; Recruiting

St. John's, Canada, NL A1E 1V4

LEO Pharma investigational site; Recruiting

Winnipeg, Canada, R3C 0N2

France

LEO Pharma investigational site; Recruiting

Martigues, Bouches-du-Rhône, France, 13500

LEO Pharma investigational site; Recruiting

Nice, France, 06000

LEO Pharma investigational site; Recruiting

Reims, France, 51100

LEO Pharma investigational site; Recruiting

Rouen, France, 76031

LEO Pharma investigational site; Recruiting

Toulouse Cedex 9, France, 31059

Poland

LEO Pharma investigational site; Recruiting

Chorzow, Poland, 41-516

LEO Pharma investigational site; Recruiting

Kraków, Poland, 30-033

LEO Pharma investigational site; Recruiting

Kraków, Poland, 31-011

LEO Pharma investigational site; Recruiting

Kraków, Poland, 31-147

LEO Pharma investigational site; Recruiting

Warszawa, Poland, 02-625

LEO Pharma investigational site; Recruiting

Wrocław, Poland, 51-318

Spain

LEO Pharma investigational site; Recruiting

Alicante, Spain, 03010

LEO Pharma investigational site; Recruiting

Barcelona, Spain, 08041

LEO Pharma investigational site; Recruiting

Esplugues de Llobregat, Spain, 08950

LEO Pharma investigational site; Recruiting

Fuenlabrada, Spain, 28942

LEO Pharma investigational site; Recruiting

Granada, Spain, 18016

LEO Pharma investigational site; Withdrawn

Pontevedra, Spain, 36001

United Kingdom

LEO Pharma investigational site; Recruiting

Ipswich, United Kingdom, IP4 5PD

LEO Pharma investigational site; Recruiting

King's Lynn, United Kingdom, PE30 4ET

LEO Pharma investigational site; Recruiting

Leytonstone, United Kingdom, E11 1NR

LEO Pharma investigational site; Recruiting

London, United Kingdom, SW10 9NH

LEO Pharma investigational site; Recruiting

Walsall, United Kingdom, WS2 9PS

Sponsors and Collaborators

LEO Pharma

Investigators

• Study Director: Medical Expert; LEO Pharma

More Information

• Responsible Party: LEO Pharma
• ClinicalTrials.gov Identifier: NCT05355818
• Other Study ID Numbers: LP0133-1426; 2021-006340-27 ( EudraCT Number )
• First Posted: May 2, 2022
• Last Update Posted: April 9, 2024
• Last Verified: April 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP)
• Access Criteria: Data sharing is subject to approved scientifically sound research proposal and signed data agreement
• URL: http://leopharmatrials.com/for-professionals

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Eczema; Dermatitis; Skin Diseases; Skin Diseases, Eczematous