Safety and Efficacy of DNK333 in Atopic Dermatitis Patients

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the safety and efficacy of DNK333 in patients with atopic dermatitis suffering from pruritus, who require systemic treatment of the disease.

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Betamethasone; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate

Criteria

Inclusion Criteria:

• Male and female atopic dermatitis patients,18 to 60 years of age inclusive, who fulfill the following criteria:

• Requirement of systemic therapy

• Itch VAS score higher than 50 mm

• EASI score higher than 8

Exclusion Criteria:

• Women of child-bearing potential who are not willing to use two highly effective methods of contraception are not allowed in the study. Similarly, men who are not willing to use two acceptable methods of contraception are not allowed in the study.

• Any systemic immunosuppressive treatment and/or phototherapy within 4 weeks prior to the first dosing.

• Use of any systemic antihistamines or topical corticosteroids within one week prior to first dosing and for the duration of the treatment period. Any other topical or oral treatment for atopic dermatitis (except emollients prescribed by the investigator) within 2 weeks prior to the first dosing will also be excluded.

Other protocol-defined inclusion/exclusion criteria may apply