At a glance
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A Phase Ⅲ Multicenter, Randomized, Double-blind, Placebo-controlled To Assess Efficacy and Safety Study of Hemay005 in Subjects With Moderate to Severe Plaque Psoriasis
In Brief
A Phase 3 clinical trial evaluating 60mg Hemay005 and Placebo for Psoriasis. Completed, enrolled 306 participants across 1 site.
Detailed Summary
Hemay005 is a novel phosphodiesterase type 4(PDE4) inhibitor being developed for the treatment of psoriasis. After single asending dose and mutiple asending dose in health subjects. phase 2 results suggest Hemay005 60 mg BID has a higher curative effect trend，and adverse reactions were mild, so we choose 60 mg BID as Hemay005 phase 3 dosage And the patients with moderate to severe plaque psoriasis will be randomized into 2 cohorts(60mg BID and placebo) approximately 306 subjects will be enrolled (204 in 60mg BID and 102 in placebo). This study includes an 16-week treatment Period, then a 36-week Treatment Period without placebo.
Study Details
Timeline
Interventions
Hemay005 is a small molecule PDE4 inhibitor.
Placebos are the same as drugs, but contain no Hemay005.