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

NCT04102241 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2021-10-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

15mg Hemay005

Hemay005 is a small molecule PDE4 inhibitor.

DRUG

Placebos

Placebos are the same as drugs, but contain no Hemay005.

Sponsors & Collaborators

  • Tianjin Hemay Pharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Min Zheng, Dr · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04102241 on ClinicalTrials.gov