A Study of Efficacy and Safety of Hemay005 Tablets in Patients With Behçet's Disease

Actively Recruiting

Phase 3

Age: 18Years - 75Years

All Genders

NCT06145893

A Study of Efficacy and Safety of Hemay005 Tablets in Patients With Behçet's Disease

Led by Ganzhou Hemay Pharmaceutical Co., Ltd · Updated on 2025-04-08

162

Participants Needed

Research Sites

137 weeks

Total Duration

AI-Summary

What this Trial Is About

This is a phase 3, multi-center, randomized, placebo-controlled, double-blind, parallel-group study with an equal randomization among the Hemay005 high dose, lower dose and placebo treatment groups. After subject randomization, each subject will enter an core-treatment Phase for 12 weeks following an extended-treatment phase for another 40 weeks and a follow up phase for 4weeks.

CONDITIONS

Official Title

A Study of Efficacy and Safety of Hemay005 Tablets in Patients With Behçet's Disease

Who Can Participate

Age: 18Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

Signed informed consent form for the study
Age between 18 and 75 years, male or female
Diagnosed with Behçet's Disease based on ICBD-2013 criteria
At least 2 oral ulcers present at screening (V1) and either at least 2 oral ulcers at randomization (V2) if V2 is 14-56 days after V1, or at least 3 oral ulcers at V2 if within 0-13 days after V1
Investigator determines systemic treatment is suitable due to severity or failure of topical treatment for oral ulcers
Women of childbearing potential and men without vasoligation must use effective contraception during the study and for 3 months after last dose
Ability to comply with follow-up and protocol requirements

You will not qualify if you...

Active Behçet's Disease lesions in major organs requiring immunosuppressive treatment
Refractory Behçet's Disease with recent gastrointestinal perforation, bleeding, or obstruction within 3 months prior to randomization
Significant heart disease or ECG abnormalities within 6 months prior to screening that pose safety risk
Use of specified immunomodulatory therapies within defined time frames before randomization
Use of systemic or intraarticular corticosteroids within 5 half-lives prior to randomization (eye drops allowed except within 24 hours before visits)
Use of certain Chinese patent medicines or decoctions within 2 weeks prior to randomization
Laboratory abnormalities including low hemoglobin, abnormal blood cell counts, elevated creatinine, bilirubin, or liver enzymes
Use of potent cytochrome P450 enzyme inducers within 4 weeks prior to randomization
Other autoimmune or chronic inflammatory diseases
Active or recurrent infections posing safety risk
Significant chest X-ray or CT abnormalities posing safety risk
History of transplantation or immunodeficiency
Positive HIV or syphilis tests
Current or recent malignant tumors within 5 years except certain skin or cervical carcinomas
Use of investigational products within 4 weeks or 5 half-lives prior to randomization
Known allergy to study drug or components
History of alcohol or drug abuse or psychiatric disorder
Conditions interfering with oral drug absorption
Prior use of apremilast
Pregnant or breastfeeding females
Serious, uncontrolled diseases posing risk or affecting study results

AI-Screening

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