This is a phase 2, multi-center, randomised, double-blind, placebo-controlled study with an equal randomization among the HSK44459 dose 1, dose 2 and placebo treatment groups. The main objective is to evaluate of the efficacy and the secondary objective is to evaluate the safety and pharmacokinetic.
Male and female subjects aged between 18 and 75 years (inclusive) at the time of signing the informed consent document.
Diagnosed with Behçet's disease (BD) meeting the International Criteria for Behçet's Disease (ICBD, ICBD-2013) criteria.
Suffered from at least 3 episodes of oral ulcers within 12 months prior to randomization.
Had at least 2 oral ulcers present during the Screening Phase.
Active involvement of major organs related to Behçet's disease - pulmonary (eg, pulmonary artery aneurysms), vascular (eg, thrombophlebitis), gastrointestinal (eg, gastrointestinal ulcers), and central nervous system (eg, meningoencephalitis) manifestations, and ocular lesions (eg, uveitis) requiring immunosuppressive treatment.
Hydroxychloroquine was used within 5 days prior to randomization;
Colchicine was used within 7 days prior to randomization;
Azathioprine, mycophenolate mofetil, baricitinib, or tofacitinib was used within 10 days prior to randomization;
Parallel
HSK44459
DrugHSK44459, bid p.o.
Placebo
DrugPlacebo, bid p.o.
Area Under the Curve for the Number of Oral Ulcers From Baseline Through treatment period.
For the analysis of the primary endpoint, the count of oral ulcers included both existing and recurrent ulcers at each time point.
Percentage of Participants Who Experienced an Oral Ulcer Complete Response at Week 12
A complete response at week 12 was defined as participants being free of oral ulcers at that time point.
Baseline in Oral Ulcer Pain as Measured by Visual Analog Scale at Week 12
The pain of oral ulcers was gauged via a 100-millimeter Visual Analog Scale. Participants were instructed to mark a single perpendicular line across the VAS at a position that corresponded to the intensity of their oral-ulcer pain experienced in the preceding 2 weeks. On this scale, 0 mm (the left-hand extremity) signified the absence of pain, while 100 mm (the right-hand extremity) represented the most excruciating pain one could envision. The measurement from the left-hand end of the scale to the perpendicular line was documented.
Percentage of Participants Who Experienced a Complete Response For Genital Ulcers at Week 12
A complete response at week 12 was defined as participants being free of genital ulcers at that time point.
Change From Baseline in Genital Ulcer Pain as Measured by VAS Score at Week 12
The pain of genital ulcers was gauged via a 100-millimeter Visual Analog Scale. Participants were instructed to mark a single perpendicular line across the VAS at a position that corresponded to the intensity of their genital-ulcer pain experienced in the preceding 2 weeks. On this scale, 0 mm (the left-hand extremity) signified the absence of pain, while 100 mm (the right-hand extremity) represented the most excruciating pain one could envision. The measurement from the left-hand end of the scale to the perpendicular line was documented.
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