NCT06145893

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a multi-center, randomized, double-blind, placebo-parallel controlled phase III clinical study. The study consists of four phases, namely the screening period, the core treatment period, the extension period, and the drug discontinuation observation period. Screening period: All subjects will undergo a screening period for up to 8 weeks prior to the baseline visit (V2, randomization day, Day 0). Core treatment period: Patients with Behçet's disease (BD) meeting the eligibility criteria upon screening will be randomized in a 1:1: 1 ratio to the Hemay005 Tablets 45 mg BID test group, Hemay005 Tablets 60 mg BID test group, or the placebo group. They will first be given escalating doses for 7 days; subsequently starting from Day 7, they will be given Hemay005 Tablets 45 mg BID or 60 mg BID or the placebo BID continuously until Week 12. Extension period: Considering benefits for subjects in the placebo group, and to observe the efficacy and safety of long-term treatment, all subjects will enter a 40-week extension period at the end of the core treatment period. Subjects enrolled in the test groups for the core treatment period will continue treatment at the dose for the core treatment period for 40 weeks during the extension period. Subjects enrolled in the placebo group for the core treatment period will be randomized in a 1:1 ratio during the extension period to either the Hemay005 Tablets 45 mg BID test group or Hemay005 Tablets 60 mg BID test group for treatment for 40 weeks. For the first week of extended treatment, subjects previously enrolled in the placebo group will need to undergo the same dose titration phase as for the core treatment period (Days 0-6), so that the same dosing schedule as for the two treatment groups would be achieved by the 7th day, in an effort to mitigate the intolerabilities such as gastrointestinal reactions, thus further protecting subjects' safety. If, during the dose titration phase of the extension period or during extended treatment, the subject cannot tolerate the prescribed dose, this will be handled at the investigator's discretion using the same method as for the core treatment period. Drug discontinuation observation period: All subjects in the study (including those who prematurely discontinued treatment for any reason) will be observed for 4 weeks following the end of the last study dose.

Conditions

• Behçet's Disease

Interventions

Type	Name	Description
DRUG	Hemay005	Hemay005 tables 60mg bid p.o;
DRUG	Hemay005	Hemay005 tables 45mg bid p.o;
DRUG	Placebo	placebo to Hemay005 tables bid p.o

Timeline

• Start date: 2023-11-13
• Primary completion: 2026-05-30
• Completion: 2026-06-30
• First posted: 2023-11-24
• Last updated: 2025-04-08

Locations

22 sites across 1 country: China