Clinical trial NCT05355818: Efficacy and Safety of Delgocitinib Cream in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hand Eczema
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2022-05-02
Enrollment: 98
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: IGA-CHE treatment success at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: HECSI-90 at Week 16
timeFrame: Week 16
measure: Reduction of HESD itch score (weekly average) of ≥4 points from baseline at Week 16
timeFrame: Week 16
measure: Reduction of HESD pain score (weekly average) of ≥4 points from baseline at Week 16
timeFrame: Week 16
measure: Reduction of HESD score (weekly average) of ≥4 points from baseline at Week 16
timeFrame: Week 16
measure: IGA-CHE treatment success at Week 2
timeFrame: Week 2
measure: IGA-CHE treatment success at Week 4
timeFrame: Week 4
measure: IGA-CHE treatment success at Week 8
timeFrame: Week 8
measure: IGA-CHE treatment success at Week 12
timeFrame: Week 12
measure: Change in cDLQI score from baseline to Week 16
timeFrame: Week 16
measure: Number of treatment emergent AEs from baseline up to Week 18
timeFrame: Week 18
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
facility: LEO Pharma investigational site
city: Mitcham
country: Australia
facility: LEO Pharma investigational site
city: Phillip
country: Australia
facility: LEO Pharma investigational site
city: Woolloongabba
country: Australia
facility: LEO Pharma investigational site
city: Brussels
country: Belgium
facility: LEO Pharma investigational site
city: Gent
country: Belgium
facility: LEO Pharma investigational site
city: Liège
country: Belgium
facility: LEO Pharma investigational site
city: Loverval
country: Belgium
facility: LEO Pharma investigational site
city: Edmonton
country: Canada
facility: LEO Pharma investigational site
city: Fredericton
country: Canada
facility: LEO Pharma investigational site
city: Kingston
country: Canada
facility: LEO Pharma investigational site
city: Montreal
country: Canada
facility: LEO Pharma investigational site
city: Red Deer
country: Canada
facility: LEO Pharma investigational site
city: St. John's
country: Canada
facility: LEO Pharma investigational site
city: Toronto
country: Canada
facility: LEO Pharma investigational site
city: Winnipeg
country: Canada
facility: LEO Pharma investigational site
city: Martigues
country: France
facility: LEO Pharma investigational site
state: Bouches-du-Rhône
city: Nice
country: France
facility: LEO Pharma investigational site
city: Reims
country: France
facility: LEO Pharma investigational site
city: Toulouse Cedex 9
country: France
facility: LEO Pharma investigational site
city: Chorzow
country: Poland
facility: LEO Pharma investigational site
city: Kraków
country: Poland
facility: LEO Pharma investigational site
city: Kraków
country: Poland
facility: LEO Pharma investigational site
city: Kraków
country: Poland
facility: LEO Pharma investigational site
city: Warszawa
country: Poland
facility: LEO Pharma investigational site
city: Wrocław
country: Poland
facility: LEO Pharma investigational site
city: Alicante
country: Spain
facility: LEO Pharma investigational site
city: Barcelona
country: Spain
facility: LEO Pharma investigational site
city: Cadiz
country: Spain
facility: LEO Pharma investigational site
city: Esplugues de Llobregat
country: Spain
facility: LEO Pharma investigational site
city: Fuenlabrada
country: Spain
facility: LEO Pharma investigational site
city: Granada
country: Spain
facility: LEO Pharma investigational site
city: Ipswich
country: United Kingdom
facility: LEO Pharma investigational site
city: King's Lynn
country: United Kingdom
facility: LEO Pharma investigational site
city: Lincoln
country: United Kingdom
facility: LEO Pharma investigational site
city: London
country: United Kingdom
facility: LEO Pharma investigational site
city: Walsall
country: United Kingdom
facility: LEO Pharma investigational site
Study officials:
affiliation: LEO Pharma
name: Medical Expert
role: STUDY_DIRECTOR
References: