Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06145893
Status:
RECRUITING
Last Update Posted:
2023-12-15
First Post:
2023-11-17
Brief Title:
A Study of Efficacy and Safety of Hemay005 Tablets in Patients With Behçets Disease
Sponsor:
Ganzhou Hemay Pharmaceutical Co Ltd
Organization:
Ganzhou Hemay Pharmaceutical Co Ltd
Study Overview
Official Title:
A Phase III Clinical Study of Efficacy and Safety of Hemay005 Tablets in Patients With Behçets Disease
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Behçets disease BD meeting the eligibility criteria upon screening will be randomized in a 11 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 11 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 investigators 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
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 Behçets disease BD meeting the eligibility criteria upon screening will be randomized in a 11 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 11 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 investigators 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None