Phase 2b Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over a 16-week Treatment Period in Adult Subjects With Chronic Hand Eczema

Key Inclusion Criteria:

- Age 18 years or above.

- Diagnosis of chronic hand eczema defined as hand eczema, which has persisted for more
than 3 months or returned twice or more within the last 12 months.

- Disease severity graded as mild to severe according to IGA (i.e., IGA ≥2).

- Recent history (within 1 year before the screening visit) of inadequate response to
topical corticosteroid treatment or topical corticosteroid treatment being medically
inadvisable.

- Diagnostic patch testing performed within 3 years prior to the screening visit.

Key Exclusion Criteria:

- Concurrent skin diseases on the hands.

- Active atopic dermatitis in regions other than the hands or psoriasis requiring
medical treatment.

- Clinically significant infection (e.g., impetiginised hand eczema) on the hands.

- Systemic treatment with immunosuppressive drugs, immunomodulating drugs, retinoids, or
corticosteroids within 4 weeks prior to baseline.

- Psoralen ultraviolet A (PUVA) or ultraviolet B (UVB) therapy on the hands within 4
weeks prior to baseline.

- Receipt of live attenuated vaccines 4 weeks prior to baseline.

- Cutaneously applied treatment with immunomodulators (e.g., phosphodiesterase-4 (PDE-4)
inhibitors, pimecrolimus, tacrolimus) or topical corticosteroids on the hands within 2
weeks prior to baseline.

- Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 2
weeks prior to baseline.

- Change in systemic antihistamine therapy within 2 weeks prior to baseline i.e.,
subjects must not start antihistamine treatment or change the current dosage regime
within 2 weeks prior to baseline.

- Other cutaneously applied therapy on the hands (except for the use of subject's own
emollients) within 1 week 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 1 week prior to
baseline.

- Receipt of any marketed or investigational biologic agents within 6 months or 5
half-lives prior to baseline or until cells count returns to normal, whichever is
longer.

- Clinically significant infection (systemic infection or serious skin infection
requiring parenteral treatment) within 4 weeks prior to baseline.

- Tuberculosis requiring treatment within 12 months prior to screening.

- History of any known primary immunodeficiency disorder including a positive human
immunodeficiency virus (HIV) test at screening, or the subject taking antiretroviral
medications.

- Any disorder which is not stable and in the investigator's opinion could affect the
safety of the subject, influence the findings of the trial, or impede the subject's
ability to complete the trial.

- Positive hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb),
hepatitis B core antibody (HBcAb), or hepatitis C virus antibody (anti-HCV) serology
at screening. Subjects with positive HBsAb may be randomised provided they are
hepatitis B vaccinated and have negative HBsAg and HBcAb.