Pharmacokinetics of Delgocitinib 20 mg/g Cream in Subjects With Chronic Hand Eczema

Inclusion Criteria:

• Age 18 years or above at screening.

• 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).

• Subjects adherent to standard non-medicated skin care including avoidance of knownand relevant irritants and allergens.

Exclusion Criteria:

• Concurrent skin diseases on the hands, e.g. tinea manuum.

• Active atopic dermatitis (AD) requiring medical treatment in regions other than thehands and feet.

• Active psoriasis on any part of the body.

• Hyperkeratotic hand eczema in combination with a history of psoriasis on any part ofthe body.

• 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.

• Cutaneously applied treatment with immunomodulators (e.g. phosphodiesterase 4 [PDE-4] inhibitors, pimecrolimus, tacrolimus) or TCS on the hands within 14 daysprior to baseline.

• Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 14 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.