Plaque Psoriasis Vulgaris Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Phase 1b Study to Assess Efficacy and Safety of One Dose Level of Oral AZD0284 Given for Four Weeks, Compared to Placebo, in Patients With Moderate to Severe Plaque Psoriasis
The Sponsor is developing the study drug, AZD0284, for the potential treatment of Plaque
psoriasis. Psoriasis is a skin condition that causes red, flaky, crusty patches of skin
covered with silvery scales. The severity of the disease varies, but in many cases it can
have a major impact on their quality of life if not adequately treated.
The purpose of the study is to determine the short term safety, pharmacodynamic and clinical
effect of AZD0284 in patients with psoriasis.
This is a randomised, double-blind, placebo-controlled, multi-centre, parallel group Phase 1b
study, designed to evaluate the pharmacodynamic effects, clinical efficacy and safety of
AZD0284 compared with placebo as measured by the relative change from baseline in Psoriasis
Area Severity Index (PASI score), other disease assessments of involved body surface area
(BSA), static physicians global assessment score (sPGA), pruritis and biomarkers associated
with the mechanism of disease and AZD0284. Disease activity will be assessed throughout the
study as will changes in skin biopsy biomarkers. The study population will be comprised of
patients with moderate to severe plaque psoriasis as defined by PASI score, BSA and sPGA.
Following completion of screening assessments and meeting all eligibility criteria, patients
will be randomised to receive AZD0284 or placebo for 4 weeks of treatment followed by a 4
week follow up period
;
| Status | Clinical Trial | Phase | |
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| Completed |
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| Completed |
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