A Study to Determine the Efficacy of ZPL-3893787 in Subjects With Plaque Psoriasis

Launched by ZIARCO PHARMA LTD · Nov 27, 2015

Keywords

ClinConnect Summary

This was a randomized, double blind, placebo controlled, parallel group study in 129 subjects with moderate to severe psoriasis with a Psoriasis Area and Severity Index (PASI) score of at least 10 and an Investigator's Global Assessment (IGA) of 3 (0-4 scale). Following run-in subjects received either oral 30 mg ZPL-3893787 once daily or placebo once daily for 12 weeks. Subjects attended the clinic at Baseline (Day 0) when they were reviewed and confirmed they met inclusion/exclusion criteria. Subjects were then randomized and received either oral 30 mg ZPL-3893787 once daily or placebo onc...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • A documented history of moderate to severe plaque psoriasis for at least 6 months prior to screening.
• • Male or female, aged ≥18 years.
• • Psoriasis Area and Severity Index (PASI) ≥10 at both Screening and Day 0.
• • An Investigator's Global Assessment (IGA) score ≥ 3 at both Screening and Day 0.
• • Psoriasis affecting ≥10% body surface area (BSA) at Screening and Day 0.
• Exclusion Criteria:
• • Current diagnosis of Pustular, Guttate, Erythrodermic, exfoliative or only nail psoriasis or a diagnosis of inverse psoriasis without having plaque psoriasis.
• • Concurrent skin disease (e.g. acne) of such severity in the study area that it could interfere with the study evaluation or presence of skin comorbidities that may interfere with study assessments.
• • Active skin infections (e.g. impetigo, abscesses) or any other clinically apparent infections.
• • Biologic treatments for psoriasis (e.g. Enbrel, Humira, Stelara, Cosentyx) within 3 months of the start of the Run-In.
• • Phototherapy (e.g. UVA, UVB, PUVA) within 4 weeks of the start of the Run-In.
• • Oral calcineurin inhibitors and immunosuppressants (e.g. cyclosporine, azathioprine, methotrexate) within 4 weeks of the start of the Run-In.
• • Systemic corticosteroids within 4 weeks of the start of the Run-In.
• • Oral antihistamines and leukotriene inhibitors and tricyclic antidepressants within 1 week of the start of the Run-In.
• • Topical steroids (any potency), topical calcineurin inhibitors (tacrolimus, pimecrolimus), salicylic acid and urea containing treatments and coaltar preparations, topical and oral retinoids and vitamin D derivatives, within 1 week of the start of the Run-In.