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

NCT06902428 | Not Yet Recruiting Phase 2

• 1 other identifier: HSK44459-202
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Behcet's Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (16)

• Percentage of Participants Who Experienced an Oral Ulcer Complete Response at Week 12

  12 weeks

• Baseline in Oral Ulcer Pain as Measured by Visual Analog Scale at Week 12

  12 weeks

• Percentage of Participants Who Experienced a Complete Response For Genital Ulcers at Week 12

  12 weeks

• Change From Baseline in Genital Ulcer Pain as Measured by VAS Score at Week 12

  12 weeks

• Change From Baseline in Disease Activity as Measured by Behçet's Disease Current Activity Form (BDCAF) at Week 12

  12 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

In treatment period, subject will take placebo matching HSK44459 twice daily in the morning and in the evening for 12 weeks. The administration time of the drug should be relatively fixed every day.

Drug: Placebo

HSK44459 dose 1

EXPERIMENTAL

In treatment period, subject will take higher dose of HSK44459 twice daily in the morning and in the evening for 12 weeks. The administration time of the drug should be relatively fixed every day.

Drug: HSK44459

HSK44459 dose 2

EXPERIMENTAL

In treatment period, subject will take lower dose of HSK44459 twice daily in the morning and in the evening for 12 weeks. The administration time of the drug should be relatively fixed every day.

Drug: HSK44459

Interventions

HSK44459 DRUG

HSK44459, bid p.o.

HSK44459 dose 1; HSK44459 dose 2

Placebo DRUG

Placebo, bid p.o.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Subjects who have used traditional Chinese patent medicines with immunomodulatory effects within 2 weeks prior to randomization; those who have taken traditional Chinese patent medicines that may affect the efficacy within 2 weeks prior to randomization;
• Patients who have previously received systemic treatment with phosphodiesterase 4 (PDE4) inhibitors;
• Patients who have used a strong CYP3A4 inhibitor or inducer within 14 days prior to randomization or within 5 pharmacokinetic half-lives (whichever is longer); and patients who insist on taking a strong CYP3A4 inhibitor or inducer during the study period;
• Subjects who have used any investigational medicinal product within 4 weeks prior to randomization or within 5 pharmacokinetic half-lives (whichever is longer);
• Laboratory tests during the screening period:
• Hemoglobin ≤ 90g/L;
• White blood cell count \< 3.0×10⁹/L or white blood cell count \> 14×10⁹/L;

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 30, 2025
• Study Start: March 24, 2025
• Primary Completion (Estimated): June 5, 2026
• Study Completion (Estimated): July 3, 2026
• Last Updated: March 30, 2025

Record last verified: 2025-03