drugset / Trial / NCT04102241

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

NCT04102241

Phase 2 Completed 216 enrolled Tianjin Hemay Pharmaceutical Co., Ltd
RandomizedParallel-groupQuadruple-blindTreatment

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. And the patients with moderate to severe plaque psoriasis will be randomized into 4 cohorts(15mg, 30mg, 60mg and placebo) approximately 216 subjects will be enrolled (52 for each cohort ). This study includes an 16-week treatment Period, then a 36-week Treatment Period without placebo.

Timeline

Start
2019-05-30
Primary completion
2020-10-12
Completion
2021-07-21

Drugs

EvaluationDrugModalityDoseRoute
Subject MUFEMILAST Small molecule 15 mg
Subject MUFEMILAST Small molecule 30 mg
Subject MUFEMILAST Small molecule 60 mg

Indications