A Study to Evaluate the Efficacy and Safety of Hemay005 in the Treatment of Behçet Disease (NCT04609397) | Clinical Trial Compass
TerminatedPhase 2
A Study to Evaluate the Efficacy and Safety of Hemay005 in the Treatment of Behçet Disease
Stopped: The study purpose has been achieved
China89 participantsStarted 2020-11-30
Plain-language summary
This is a phase 2, 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 12weeks and a follow up phase for 4weeks.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. at least 2 oral ulcers at V2 if V2 occurs at least 14 days after Visit 1, OR
. at least 3 oral ulcers at V2 if V2 occurs at least 0\~42 days after Visit 1.
Exclusion criteria
. Previous major organ involvement is allowed if it occurred at least one years prior to screening visit and is not active at time of enrollment.
. Subjects with BD-related arthritis and BD-skin manifestations are also allowed
. 7 days prior to Visit 2 (randomization) for colchicine.
. 10 days prior to Visit 2 (randomization) for azathioprine, mycophenolate mofetil, baricitinib or Tofacitinib.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial for Behçet's disease using Hemay005 was terminated early — can you find out why it was stopped, and what that means for what we actually know about whether the drug is safe or effective?
2Since this was only a Phase 2 trial before it was terminated, does that mean there's still very limited safety and efficacy data on Hemay005, and how does that compare to existing treatments for Behçet's disease that already have more established evidence?
3Given that this trial is no longer recruiting or running, are there any other active clinical trials for Behçet's disease that you think might be worth exploring as an alternative?
4For my specific symptoms of Behçet's disease, would standard approved treatments be a more reliable first step right now, especially since the evidence from this terminated trial may be incomplete?
5Is there any published data from this trial, even partial results, that you could review to help us understand whether Hemay005 showed any signal of benefit or raised any safety concerns before it was stopped?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
to evaluate the efficacy of Hemay005 in the treatment of Behçet's disease.