Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over an 8-week Treatment Period in Adult Subjects With Atopic Dermatitis.
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; 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: 251.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a double-blind, multi-centre, randomised, 5-arm, vehicle-controlled, parallel-group
      trial. The trial is designed to establish a dose-response signal and investigate the efficacy
      and safety of delgocitinib cream in the treatment of adult subjects with mild to severe
      atopic dermatitis (AD).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Age 18 years and above.

          -  Diagnosis of AD as defined by the Hanifin and Rajka 1980 criteria for AD.

          -  History of AD for ≥1 year.

          -  AD involvement of 5-50% treatable body surface area at screening and at baseline
             (excluding scalp).

          -  Disease severity graded as mild to severe according to vIGA-AD (i.e. vIGA-AD ≥2) at
             screening and baseline.

        Key Exclusion Criteria:

          -  AD lesion(s) on scalp at screening and/or baseline.

          -  Active dermatologic conditions that may confound the diagnosis of AD or would
             interfere with assessment of treatment, such as scabies, cutaneous lymphoma, rosacea,
             urticaria, or psoriasis.

          -  Known active allergic or irritant contact dermatitis that is likely to interfere with
             the assessment of severity of AD.

          -  Use of tanning beds or phototherapy within 4 weeks prior to baseline.

          -  Systemic treatment with immunosuppressive/modulating drugs or corticosteroids within 4
             weeks prior to baseline or 3 or more bleach baths any week within 4 weeks prior to
             baseline.

          -  Treatment with topical corticosteroids, topical calcineurin inhibitors, topical
             phosphodiesterase-4 inhibitors, or oral antibiotics within 2 weeks prior to baseline.

          -  Change in systemic antihistamine therapy within 2 weeks prior to baseline i.e. the
             subjects must not start antihistamine treatment or change the current dosage regime
             within 2 weeks prior to baseline.

          -  Receipt of live attenuated vaccines within 4 weeks prior to baseline.

          -  Treatment with any marketed or investigational biologic agents within 6 months or 5
             half-lives prior to baseline, or until cell counts return to normal, whichever is
             longer.

          -  History of any active skin infection within 1 week prior to baseline.

          -  Clinically significant infection (systemic infection or serious skin infection
             requiring parenteral treatment) within 4 weeks prior to baseline.