A Phase 2b, Double-blind, Randomised, 5-arm, Vehicle-controlled, Dose Ranging Trial to Evaluate the Efficacy and Safety of Twice Daily Topical Applications of Delgocitinib Cream 1, 3, 8, 20 mg/g for 8 Weeks in Adult Subjects With Mild to Severe Atopic Dermatitis.
Description
Brief 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
N/AInclusion and Exclusion 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
- 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.
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
Powered by
SC CTSI