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Clinical trial

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

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Last updated:30th May 2019
Identifier: NCT04102241

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 Type: Interventional  (Clinical Trial)
Estimated Enrollment: 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase ? Efficacy and Safety Study of Hemay005 in Subjects With Moderate to Severe Plaque Psoriasis
Actual Study Start Date: May 30, 2019
Estimated Primary Completion Date: April 10, 2020
Estimated Study Completion Date: May 20, 2021

Arms:
- Placebo Comparator:
Placebo
- Experimental: 15mg Hemay005
- Experimental: 30mg Hemay005
- Experimental: 60mg Hemay005

Category Value
Date last updated at source 2019-09-25
Study type(s) Interventional
Expected enrolment 216
Study start date 2019-05-30
Estimated primary completion date 2020-04-10

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