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

Inclusion Criteria:

• 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.

• Subjects who have a documented history of inadequate response to treatment with TCSor 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 orintranasal steroids corresponding to up to 1 mg prednisolone for allergicconjunctivitis, asthma, or rhinitis are allowed).

• Use of tanning beds, phototherapy, or bleach baths on the hands within 28 days priorto 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 14days 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.