NCT04839328

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 306 (actual)
• Sponsor: Tianjin Hemay Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	60mg Hemay005	Hemay005 is a small molecule PDE4 inhibitor.
DRUG	Placebo	Placebos are the same as drugs, but contain no Hemay005.

Timeline

• Start date: 2022-01-20
• Primary completion: 2022-10-25
• Completion: 2023-07-28
• First posted: 2021-04-09
• Last updated: 2024-01-16

Locations

1 site across 1 country: China