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A Phase Ⅲ Efficacy and Safety Study of Hemay005 in Subjects With Moderate to Severe Plaque Psoriasis

Psoriasis Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

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. Primary Objectives: To evaluate the effectiveness of Hemay005 tablets 60 mg twice daily (BID) compared with placebo in patients with moderate to severe chronic plaque psoriasis. Secondary objective： 1. Evaluate other efficacy characteristics of Hemay005 tablets 60 mg BID compared with placebo in patients with moderate to severe chronic plaque psoriasis. 2. Evaluate the safety of Hemay005 tablets 60 mg BID in patients with moderate to severe chronic plaque psoriasis. 3. To evaluate the population pharmacokinetics (PPK) characteristics of Hemay005 tablets 60 mg BID in patients with moderate to severe chronic plaque psoriasis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04839328
Study type Interventional
Source Ganzhou Hemay Pharmaceutical Co., Ltd
Contact
Status Completed
Phase Phase 3
Start date January 20, 2022
Completion date July 28, 2023
View Details
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