Chronic Hand Eczema MedDRA version: 23.1 Level: LLT Classification code 10084778 Term: Chronic hand eczema System Organ Class: 100000004858
Conditions
Sponsors
LEO Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
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 history of inadequate response to treatment with TCS (at any time within 1 year before the screening visit - see protocol for definition of inadequate response) or for whom TCS are documented to be otherwise medically inadvisable (e.g. due to important side effects or safety risks - see protocol for definition or important side effects or safety risks). Are the trial subjects under 18? yes Number of subjects for this age range: 92 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Concurrent skin disease 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. UVB, UVA1, 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 or impede the subject’s ability to complete the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of twice daily applications of delgocitinib cream 20 mg/g compared with cream vehicle in the treatment of adolescents with moderate to severe CHE.;Secondary Objective: To evaluate the safety of twice daily applications of delgocitinib cream 20 mg/g in the treatment of adolescents with moderate to severe CHE.;Primary end point(s): • IGA CHE TS;Timepoint(s) of evaluation of this end point: Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • HECSI 90 at Week 16 • IGA-CHE TS at Weeks 2, 4, 8, and 12 • Reduction of HESD itch score (weekly average) of =4 points from baseline at Week 16 • Reduction of HESD pain score (weekly average) of =4 points from baseline at Week 16 • Reduction of HESD score (weekly average) of =4 points from baseline at Week 16 • Change in cDLQI score from baseline to Week 16 • Number of treatment emergent AEs from baseline up to Week 18 ;Timepoint(s) of evaluation of this end point: As specified for each endpoint. | — |
Countries
Australia, Belgium, Canada, France, Poland, Spain, United Kingdom
Contacts
Public ContactGlobal Regulatory Affairs
LEO Pharma A/S
Outcome results
None listed