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.

• Status: Completed
• Trial end date: 2020-05-19
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LEO Pharma

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.