Efficacy and Safety Study of Hemay005 in Subjects With Moderate to Severe Plaque Psoriasis
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.
Study Design
Conditions
Intervention
15mg Hemay005, Placebos
Location
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou
Zhejiang
China
310009
Status
Recruiting
Source
Tianjin Hemay Pharmaceutical Co.,Ltd
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT04102241
- ClinicalTrials.gov processed this data on September 27, 2019
Published on BioPortfolio: 2019-09-30T07:07:10-0400
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Medical and Biotech [MESH] Definitions
Placebos
Any dummy medication or treatment. Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol.
Psoriasis
A common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches. The lesions have a predilection for nails, scalp, genitalia, extensor surfaces, and the lumbosacral region. Accelerated epidermopoiesis is considered to be the fundamental pathologic feature in psoriasis.
Desoximetasone
A topical anti-inflammatory glucocorticoid used in DERMATOSES, skin allergies, PSORIASIS, etc.
Halcinonide
A glucocorticoid used topically in the treatment of DERMATITIS; ECZEMA; or PSORIASIS. It may cause skin irritation.
Anthralin
An anthracene derivative that disrupts MITOCHONDRIA function and structure and is used for the treatment of DERMATOSES, especially PSORIASIS. It may cause FOLLICULITIS.
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