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

Chronic Hand Eczema Clinical Trial

— DELTA TEEN  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05355818
• Other study ID #: LP0133-1426
• Secondary ID: 2021-006340-27
• Status: Recruiting
• Phase: Phase 3
• Start date: July 14, 2022
• Est. completion date: December 17, 2024

Study information

• Verified date: April 2024
• Source: LEO Pharma
• Contact: Clinical Disclosure
• Phone: (+1) 877-557-1168
• Email: clinicaltrialscontactus[@]leo-pharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: December 17, 2024
• Est. primary completion date: December 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hand Eczema
• Eczema

Intervention

Drug:
• Delgocitinib
Cream for topical application
• Cream vehicle
The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.

Locations

Country	Name	City	State
Australia	LEO Pharma investigational site	Darlinghurst
Australia	LEO Pharma investigational site	Mitcham
Australia	LEO Pharma investigational site	Phillip
Australia	LEO Pharma investigational site	Woolloongabba
Belgium	LEO Pharma investigational site	Brussels
Belgium	LEO Pharma investigational site	Gent
Belgium	LEO Pharma investigational site	Liège
Belgium	LEO Pharma investigational site	Loverval
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	Winnipeg
France	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	Rouen
France	LEO Pharma investigational site	Toulouse Cedex 9
Poland	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	Wroclaw
Spain	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
United Kingdom	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	London
United Kingdom	LEO Pharma investigational site	Walsall

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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