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
Condition: Chronic Hand Eczema
MeSH terms: Eczema
Intervention: Delgocitinib cream; Delgocitinib cream vehicle
Intervention description: Cream for topical application.; The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 258.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research trial was to test different strengths of a new trial medication,
      delgocitinib cream 1, 3, 8, and 20 mg/g, and to investigate how treatment with delgocitinib
      cream affects chronic hand eczema. This was judged by a range of assessments that rate the
      severity and extent of chronic hand eczema and its symptoms, as well as general health status
      and quality of life.
    

Eligibility criteria:

        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 e.g tinnea manuum.

          -  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 and/or subjects
             with a positive blood test for tuberculosis at 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.