Trials / Completed
CompletedNCT04102241
Efficacy and Safety Study of Hemay005 in Subjects With Moderate to Severe Plaque Psoriasis
A Phase Ⅱ Efficacy and Safety Study of Hemay005 in Subjects With Moderate to Severe Plaque Psoriasis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 216 (actual)
- Sponsor
- Tianjin Hemay Pharmaceutical Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 75 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. 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
| Type | Name | Description |
|---|---|---|
| DRUG | 15mg Hemay005 | Hemay005 is a small molecule PDE4 inhibitor. |
| DRUG | Placebos | Placebos are the same as drugs, but contain no Hemay005. |
Timeline
- Start date
- 2019-05-30
- Primary completion
- 2020-10-12
- Completion
- 2021-07-21
- First posted
- 2019-09-25
- Last updated
- 2021-10-13
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04102241. Inclusion in this directory is not an endorsement.