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Tests treatment safety and results for Behçet's Disease
Official title A Study of Efficacy and Safety of Hemay005 Tablets in Patients With Behçet's Disease
ClinicalTrials.gov ID: NCT06145893
What this study is testing
What is Hemay005?
Hemay005 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for behçet's disease.
Also referred to as Mufemilast, Phosphodiesterase 4 (PDE4) inhibitors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase 3, 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 40 weeks and a follow up phase for 4weeks.
- Phase 3: a large, late-stage study
- Time commitment: about 8 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Understanding and voluntarily signing the Informed Consent Form (ICF) for this study;
- Age 18-75 years (inclusive), male or female;
- Diagnosed as BD based on the ICBD-2013;
- At least 2 oral ulcers present at V1 (screening), and:
- at least 2 oral ulcers present at V2 (the day of randomization) when V2 occurs 14-56 days after V1; OR
You likely can't join if
- Active lesions associated with BD in major organs requiring immunosuppressive treatment, e.g., those in lungs (e.g., pulmonary aneurysm), blood...
- Any clinically significant heart disease (including but not limited to: unstable ischemic heart disease, NYHA III/IV left ventricular failure, or...
- 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;
See the full eligibility criteria
Who can join
- Understanding and voluntarily signing the Informed Consent Form (ICF) for this study;
- Age 18-75 years (inclusive), male or female;
- Diagnosed as BD based on the ICBD-2013;
- At least 2 oral ulcers present at V1 (screening), and:
- at least 2 oral ulcers present at V2 (the day of randomization) when V2 occurs 14-56 days after V1; OR
- at least 3 oral ulcers present at V2 (the day of randomization) when V2 occurs 0-13 days after V1;
- 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...
- Throughout the study period from signing of ICF through 3 months after the last study dose, women of childbearing potential and male people who have not undergone vasoligation should use effective contraceptive...
- Being able to comply with the follow-up schedule and other protocol requirements.
What rules you out
- 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)...
- 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...
- 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;
- Intraarticular or systemic corticosteroid treatment prior to randomization and within 5 pharmacokinetic/pharmacodynamic half-lives; Note: For people with eye symptoms, glucocorticoid eye drops are allowed throughout the...
- 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 how well it works...
- Laboratory tests:
- Hemoglobin ≤85g/L;
- White blood cell count \ 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...
- Use of potent inducers of cytochrome P450 enzymes (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin sodium) within 4 weeks prior to randomization;
- 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...
- 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...
- 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...
- History of transplantation or immunodeficiency;
- Positive for human immunodeficiency virus (HIV) antibody or treponema pallidum antibody test;
- 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...
- Use of any clinical investigational product within 4 weeks prior to randomization or 5 pharmacokinetic/pharmacodynamic half-lives, whichever is longer; Note: people who have participated in HM005BD2S01 study are not...
- Known allergy to the study drug or any of its components or allergic constitution;
- A history of alcohol or drug abuse or dependence, or psychiatric disorder;
- 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...
- Prior use of apremilast;
- Female people who are pregnant or breast feeding;
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Xiamen, Fujian, China
- Guangzhou, Guangdong, China
- Shenzhen, Guangdong, China
- Guilin, Guangxi, China
- Shijiazhuang, Hebei, China
- Xinxiang, Henan, China
- Nanchang, Jiangsu, China
- Suzhou, Jiangsu, China
- Xuzhou, Jiangsu, China
- Changchun, Jilin, China
- Linyi, Shandong, China
- Shanghai, Shanghai Municipality, China
- Taiyuan, Shanxi, China
- Hangzhou, Zhejiang, China
- Wenzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 8 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Xiamen, Fujian, China; Guangzhou, Guangdong, China; Shenzhen, Guangdong, China; Guilin, Guangxi, China; Shijiazhuang, Hebei, China and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.