Not Yet RecruitingPhase 2

Evaluating the Efficacy and Safety of of HSK44459 in Patients With Behçet's Disease

120 participantsStarted 2025-03-24

Plain-language summary

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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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.
✓. Had received drug treatment for Behçet's disease.
✓. Eligible for systemic treatment of oral ulcers.
✓. Consented to participate in this trial, and voluntarily signed the informed consent form.

Exclusion criteria

✕. 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.
✕. Subjects who have received the following immunomodulatory treatments, including:
✕. 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;
✕. Cyclosporine, methotrexate, cyclophosphamide, thalidomide, or dapsone was used within 4 weeks (28 days) prior to randomization;
✕. Biological agents were used within 5 half-lives prior to randomization;
✕. Subjects who have received systemic corticosteroid treatment prior to randomization;

What they're measuring

Area Under the Curve for the Number of Oral Ulcers From Baseline Through treatment period.

Timeframe: 12 weeks

Trial details

NCT IDNCT06902428

SponsorHaisco Pharmaceutical Group Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-05

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