Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to assess the efficacy and safety of adalimumab in combination with topical psoriasis treatment, calcipotriol/betamethasone, vs. adalimumab in combination with matching vehicle in subjects with moderate to severe chronic plaque psoriasis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Adalimumab; Betamethasone; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Calcipotriene; Calcitriol

Criteria

Inclusion Criteria:

• Subject is >= 18 years of age

• Subject had a clinical diagnosis of chronic plaque psoriasis for at least 6 months, and has moderate to severe plaque psoriasis

• Subject must have been treated and failed to respond to, or has a contraindication to, or is intolerant to at least two different systemic therapies, one of which must be cyclosporine, or methotrexate or oral PUVA

• Subject is judged to be in generally good health as determined by the principal investigator

Exclusion Criteria:

• Subject has previous exposure to adalimumab

• Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVB or PUVA phototherapy

• Subject is taking or requires oral or injectible corticosteroids

• Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced or medication-exacerbated psoriasis or new onset guttate psoriasis

• Subject considered by the investigator, for any reason, to be an unsuitable candidate

• Female subject who is pregnant or breast-feeding or considering becoming pregnant

• Subject has a calcium metabolism disorder