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

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 monthsor returned twice or more within the last 12 months.

• Disease severity graded as moderate to severe at screening and baseline according toIGA CHE (i.e. an IGA-CHE score of 3 or 4).

• Subjects who have a documented recent history of inadequate response to treatmentwith topical corticosteroids (TCS) (at any time within 1 year before the screeningvisit) or for whom TCS are documented to be otherwise medically inadvisable (e.g.due to important side effects or safety risks).

• Inadequate response is defined as a history of failure to achieve and maintaina low disease activity state (comparable to an IGA-CHE score of ≤2) despitetreatment with a daily regimen of TCS of class III-IV (potent to very potent)for Europe and Australia and class IV-I (medium potency to very/ultra-highpotency) for Canada, applied for at least 28 days or for the maximum durationrecommended by the product prescribing information, whichever is shorter.

• Important side effects or safety risks are those that outweigh the potentialtreatment benefits and include intolerance to treatment, hypersensitivityreactions, and significant skin atrophy as assessed by the physician.

Exclusion Criteria:

• Concurrent skin diseases 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), orcorticosteroids within 28 days prior to baseline (steroid eyedrops and inhaled orintranasal steroids corresponding to up to 1 mg prednisolone for allergicconjunctivitis, asthma, or rhinitis are allowed).

• Use of tanning beds, phototherapy (e.g. ultraviolet B (UVB), ultraviolet A1 (UVA1),psoralen ultraviolet A (PUVA)), or bleach baths on the hands within 28 days prior tobaseline.

• 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 ownemollients) within 7 days prior to baseline.

• Cutaneously applied treatments in regions other than the hands, which couldinterfere with clinical trial evaluations or pose a safety concern within 7 daysprior 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. Examples include but arenot limited to cardiovascular, gastrointestinal, hepatic, renal, neurological,musculoskeletal, infectious, endocrine, metabolic, haematological,immunological, and psychiatric disorders, and major physical impairment.