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 range18 Years – 75 Years
SexALL
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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.
✕. 4 weeks prior to visit 2(randomization) for cyclosporin, methotrexate, cyclophosphamide, thalidomide, and dapsone.
✕. At least 5 terminal half-lives for all biologics, including,within:
✕. Four weeks prior to visit 2(randomization) for etanercept.
What they're measuring
1
to evaluate the efficacy of Hemay005 in the treatment of Behçet's disease.