Efficacy and safety of Hemay005 tablets for Behçet's disease

A Phase III Clinical Study of Efficacy and Safety of Hemay005 Tablets in Patients With Behçet's Disease

This study is testing if Hemay005 tablets can help people with Behçet's disease feel better and be safe to use.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 162 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd (Industry-sponsored)
• Drugs / interventions: Infliximab, Adalimumab, golimumab, tolizumab, Secukinumab, baritinib, tofacitinib, methotrexate, cyclophosphamide
• Locations: 22 sites (Beijing, Beijing Municipality and 21 other locations)
• Trial ID: NCT06145893 on ClinicalTrials.gov

What this trial studies

This phase 3 clinical trial evaluates the efficacy and safety of Hemay005 tablets in patients diagnosed with Behçet's disease. The study involves a multi-center, randomized, double-blind, placebo-controlled design with participants assigned to either a high dose, lower dose, or placebo group. The trial consists of a core treatment phase lasting 12 weeks, followed by a 40-week extension phase for those in the placebo group to assess long-term treatment effects. Participants will be monitored for a total of 4 weeks after treatment completion.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with a confirmed diagnosis of Behçet's disease and specific oral ulcer criteria.

Not a fit: Patients whose oral ulcers can be effectively managed with topical treatments may not benefit from this systemic approach.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of Behçet's disease and enhance patients' quality of life.

How similar studies have performed: Previous studies have shown promise in treating Behçet's disease with similar systemic therapies, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Understanding and voluntarily signing the Informed Consent Form (ICF) for this study;
2. Age 18-75 years (inclusive), male or female;
3. Diagnosed as BD based on the ICBD-2013;
4. At least 2 oral ulcers present at V1 (screening), and:

   1. at least 2 oral ulcers present at V2 (the day of randomization) when V2 occurs 14-56 days after V1; OR
   2. at least 3 oral ulcers present at V2 (the day of randomization) when V2 occurs 0-13 days after V1;
5. Applicability of systemic treatment for oral ulcers: Based on the severity of the disease and the involved area, the investigator determines that the patient's oral ulceration is not suitable for topical treatment or that the patient's oral ulceration cannot be effectively controlled by topical treatment, so that systemic treatment is to be used;
6. Throughout the study period from signing of ICF through 3 months after the last study dose, women of childbearing potential and male subjects who have not undergone vasoligation should use effective contraceptive measures, including vasoligation, abstinence, intrauterine device (IUD), hormones (oral, patches, rings, injections, implants) and barrier methods (diaphragms, cervical caps, sponges, condoms);
7. Being able to comply with the follow-up schedule and other protocol requirements.

Exclusion Criteria:

1. Active lesions associated with BD in major organs requiring immunosuppressive treatment, e.g., those in lungs (e.g., pulmonary aneurysm), blood vessels (e.g., thrombophlebitis, recurrent malignant aneurysms), gastrointestinal tract (e.g., gastrointestinal ulcers), and central nervous system (e.g., meningoencephalitis); Note: Patients with refractory BD who experienced gastrointestinal perforation, active bleeding, or obstruction, etc. within 3 months prior to randomization are to be excluded.
2. Any clinically significant heart disease (including but not limited to: unstable ischemic heart disease, NYHA III/IV left ventricular failure, or myocardial infarction) or clinically significant 12-lead ECG abnormalities detected during the 6 months prior to screening, which, at the investigator's discretion, may put the subject at safety risk or may interfere with the study assessments;
3. Use of the following immunomodulatory therapies:

   * Colchicine within 7 days prior to randomization;
   * Perazathioprine, mycophenolate, baritinib, or tofacitinib within 10 days prior to randomization;
   * Cyclosporine, methotrexate, cyclophosphamide, thalidomide, or dapsone within 4 weeks (28 days) prior to randomization;
   * Biologics within 5 half-lives prior to randomization, e.g.:

     * Etanercept within 4 weeks prior to randomization;
     * Infliximab or leflunomide within 8 weeks prior to randomization;
     * Adalimumab, golimumab, abatacept, or tolizumab within 10 weeks prior to randomization;
     * Secukinumab within 6 months prior to randomization;
4. Intraarticular or systemic corticosteroid treatment prior to randomization and within 5 pharmacokinetic/pharmacodynamic half-lives; Note: For subjects with eye symptoms, glucocorticoid eye drops are allowed throughout the trial (except for within 24 hours prior to a trial visit).
5. Chinese patent medicines with immunomodulatory effect within 2 weeks prior to randomization; any Chinese pate nt medicines or decoctions within 2 weeks prior to randomization that might affect efficacy evaluation, or containing sinomenine, total glucoside of paeony, or tripterygium wilfordii, etc.;
6. Laboratory tests:

   * Hemoglobin ≤85g/L;
   * White blood cell count \<3.0×10\^9/L or \>14×10\^9/L;
   * Platelets \<100×10\^9/L;
   * Serum creatinine \>1.5 mg/dL (\>132.6 μmol/L);
   * Total bilirubin of \>2.0 mg/dL (\>34.2 μmol/L);
   * Both aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥1.5×ULN; Note: The above tests can be repeated at most once during the screening period. If the result within 2 weeks prior to randomization falls into the specified range, the subject is eligible for the study;
7. Use of potent inducers of cytochrome P450 enzymes (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin sodium) within 4 weeks prior to randomization;
8. Other autoimmune diseases or chronic inflammatory diseases associated with immunity, e.g., rheumatic fever, rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis, multiple sclerosis, Sjögren's syndrome, and inflammatory bowel disease;
9. Currently active infections or recurrent bacterial, fungal, viral, mycobacterial or other infectious diseases (including but not limited to tuberculosis, atypical mycobacteriosis, hepatitis B, hepatitis C, herpes zoster, histoplasmosis, and coccidiosis; however, onychomycosis is excluded), which, at the investigator's discretion, may put the subject at safety risk; Note: Subjects positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody, or with a history of active mycobacterial infection of any species (including Mycobacterium tuberculosis) within 3 years prior to screening visit should be excluded. Screening is permitted if the subject has been cured for at least 3 years prior to randomization with documentation available for verification;
10. Clinically significant chest X-ray or CT abnormalities, which, at the investigator's discretion, may put the subject at safety risk; Note: If a chest X-ray or CT was performed within 3 months prior to V1, the examination may be omitted for V1;
11. History of transplantation or immunodeficiency;
12. Positive for human immunodeficiency virus (HIV) antibody or treponema pallidum antibody test;
13. Currently having a malignant tumor, or a history of any malignant tumor within 5 years prior to screening (except for treatment-experienced squamous cell carcinoma in situ of the skin, basal cell carcinoma or cervical carcinoma in situ with no evidence of relapse within the past 12 months);
14. Use of any clinical investigational product within 4 weeks prior to randomization or 5 pharmacokinetic/pharmacodynamic half-lives, whichever is longer; Note: Subjects who have participated in HM005BD2S01 study are not eligible to participate in this trial;
15. Known allergy to the study drug or any of its components or allergic constitution;
16. A history of alcohol or drug abuse or dependence, or psychiatric disorder;
17. Any conditions that may interfere with oral drug absorption, e.g., subtotal gastrectomy, clinically significant diabetic gastrointestinal disease, or certain types of bariatric surgery such as gastric bypass surgery, not including procedures that simply separate the stomach into separate chambers such as gastric banding surgery;
18. Prior use of apremilast;
19. Female subjects who are pregnant or breast feeding;
20. Concomitant serious, progressive, or uncontrolled diseases, with which participation in the study may, at the investigator's discretion, put the subject at potential risk or affect the interpretation of study results.

Where this trial is running

Beijing, Beijing Municipality and 21 other locations

• Beijing Friendship hospital capital medical hospital — Beijing, Beijing Municipality, China (Recruiting)
• Peking university first hospital — Beijing, Beijing Municipality, China (Recruiting)
• Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Peking university third hospital — Beijing, Beijing Municipality, China (Recruiting)
• Xuanwu hospital capital medical university — Beijing, Beijing Municipality, China (Recruiting)
• The first affiliated hospital of Xiamen University — Xiamen, Fujian, China (Recruiting)
• Guangdong second provincial central hospital — Guangzhou, Guangdong, China (Recruiting)
• Sun Yat-Sen memorial hospital — Guangzhou, Guangdong, China (Recruiting)
• The third affiliated hospital sun yat-sen university — Guangzhou, Guangdong, China (Recruiting)
• The university of Hong Kong-Shenzhen Hospital — Shenzhen, Guangdong, China (Recruiting)
• Affiliated hospital of Guilin Medical university — Guilin, Guangxi, China (Recruiting)
• The second hospital of Hebei medical university — Shijiazhuang, Hebei, China (Not_yet_recruiting)
• Xinxiang Central hospital — Xinxiang, Henan, China (Recruiting)
• The first affiliated hospital of Nanchang university — Nanchang, Jiangsu, China (Recruiting)
• The first affiliated hospital of Soochow university — Suzhou, Jiangsu, China (Recruiting)
• The affiliated hospital of Xuzhou medical university — Xuzhou, Jiangsu, China (Recruiting)
• Jilin Province People's hospital — Changchun, Jilin, China (Recruiting)
• Linyi People's Hospital — Linyi, Shandong, China (Not_yet_recruiting)
• Tongji hospital of Tongji university — Shanghai, Shanghai Municipality, China (Recruiting)
• Second hospital of shanxi medical university — Taiyuan, Shanxi, China (Not_yet_recruiting)
• The first affiliated hospital, Zhejiang University school of medicine — Hangzhou, Zhejiang, China (Recruiting)
• The first affiliated hospital of Wenzhou Medical university — Wenzhou, China (Recruiting)

Study contacts

• Principal investigator: Zhanguo Li, Doctor — Peking University People's Hospital
• Study coordinator: Jinfeng Lin

Conditions Behçet's Disease