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 formore 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 totopical corticosteroid treatment or topical corticosteroid treatment being medicallyinadvisable.

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

Key Exclusion Criteria:

• Concurrent skin diseases on the hands e.g tinnea manuum.

• Active atopic dermatitis in regions other than the hands or psoriasis requiringmedical 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 4weeks 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 thehands within 2 weeks prior to baseline.

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

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

• Cutaneously applied treatments in regions other than the hands, which couldinterfere with clinical trial evaluations or pose a safety concern within 1 weekprior to baseline.

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

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

• Tuberculosis requiring treatment within 12 months prior to screening and/or subjectswith a positive blood test for tuberculosis at screening.

• History of any known primary immunodeficiency disorder including a positive humanimmunodeficiency virus (HIV) test at screening, or the subject taking antiretroviralmedications.

• Any disorder which is not stable and in the investigator's opinion could affect thesafety of the subject, influence the findings of the trial, or impede the subject'sability 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) serologyat screening. Subjects with positive HBsAb may be randomised provided they arehepatitis B vaccinated and have negative HBsAg and HBcAb.