MedTrace Logo

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

NCT04839328 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2024-01-16

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. phase 2 results suggest Hemay005 60 mg BID has a higher curative effect trend，and adverse reactions were mild, so we choose 60 mg BID as Hemay005 phase 3 dosage And the patients with moderate to severe plaque psoriasis will be randomized into 2 cohorts(60mg BID and placebo) approximately 306 subjects will be enrolled (204 in 60mg BID and 102 in placebo). This study includes an 16-week treatment Period, then a 36-week Treatment Period without placebo.

Conditions

Interventions

DRUG

60mg Hemay005

Hemay005 is a small molecule PDE4 inhibitor.

DRUG

Placebo

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

Sponsors & Collaborators

  • Tianjin Hemay Pharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • jianzhong Zhang · Peking University People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-20
Primary Completion
2022-10-25
Completion
2023-07-28

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
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 NCT04839328 on ClinicalTrials.gov