ClinicalTrials.gov record NCT06145893
A Study of Efficacy and Safety of Hemay005 Tablets in Patients With Behçet's Disease
A Phase III Clinical Study of Efficacy and Safety of Hemay005 Tablets in Patients With Behçet's Disease
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This Phase 3, randomized, triple-masked, placebo-controlled study compares two oral doses of Hemay005 with placebo in people with Behçet's disease who have oral ulcers. The core treatment period is 12 weeks, followed by a 40-week extension (placebo participants switch to active drug) and a 4‑week drug discontinuation observation. Dosing begins with a 7‑day escalation then continues twice daily during treatment periods.
What it is studying. The study compares Hemay005 tablets at two fixed oral doses (45 mg twice daily and 60 mg twice daily) against placebo to measure effects on oral ulcers and to collect safety and drug-level information. Main measures include the number of oral ulcers over 12 weeks, rates of being free of oral ulcers, pain scores, disease activity scores, other organ-specific outcomes (skin, eye, gut, joints), pharmacokinetics, and adverse events.
What the researchers hope to learn. To assess whether Hemay005 affects the number and pain of oral ulcers in Behçet's disease, to measure disease activity and organ-specific outcomes, to evaluate safety and tolerability, and to characterize population pharmacokinetics.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- Hemay005
- Placebo
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- 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 that the patient's oral ulceration cannot be effectively controlled by topical treatment, so that systemic treatment is to be used;
- 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);
- Being able to comply with the follow-up schedule and other protocol requirements.
Exclusion criteria
- 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.
- 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;
- 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 subjects with eye symptoms, glucocorticoid eye drops are allowed throughout the trial (except for within 24 hours prior to a trial visit).
- 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.;
- 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;
- 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, and inflammatory bowel disease;
- 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;
- 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;
- 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 carcinoma in situ with no evidence of relapse within the past 12 months);
- 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;
- 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, not including procedures that simply separate the stomach into separate chambers such as gastric banding surgery;
- Prior use of apremilast;
- Female subjects 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.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
This is a multi-center, randomized, double-blind, placebo-parallel controlled phase III clinical study. The study consists of four phases, namely the screening period, the core treatment period, the extension period, and the drug discontinuation observation period. Screening period: All subjects will undergo a screening period for up to 8 weeks prior to the baseline visit (V2, randomization day, Day 0). Core treatment period: Patients with Behçet's disease (BD) meeting the eligibility criteria upon screening will be randomized in a 1:1: 1 ratio to the Hemay005 Tablets 45 mg BID test group, Hemay005 Tablets 60 mg BID test group, or the placebo group. They will first be given escalating doses for 7 days; subsequently starting from Day 7, they will be given Hemay005 Tablets 45 mg BID or 60 mg BID or the placebo BID continuously until Week 12. Extension period: Considering benefits for subjects in the placebo group, and to observe the efficacy and safety of long-term treatment, all subjects will enter a 40-week extension period at the end of the core treatment period. Subjects enrolled in the test groups for the core treatment period will continue treatment at the dose for the core treatment period for 40 weeks during the extension period. Subjects enrolled in the placebo group for the core treatment period will be randomized in a 1:1 ratio during the extension period to either the Hemay005 Tablets 45 mg BID test group or Hemay005 Tablets 60 mg BID test group for treatment for 40 weeks. For the first week of extended treatment, subjects previously enrolled in the placebo group will need to undergo the same dose titration phase as for the core treatment period (Days 0-6), so that the same dosing schedule as for the two treatment groups would be achieved by the 7th day, in an effort to mitigate the intolerabilities such as gastrointestinal reactions, thus further protecting subjects' safety. If, during the dose titration phase of the extension period or during extended treatment, the subject cannot tolerate the prescribed dose, this will be handled at the investigator's discretion using the same method as for the core treatment period. Drug discontinuation observation period: All subjects in the study (including those who prematurely discontinued treatment for any reason) will be observed for 4 weeks following the end of the last study dose.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
After up to 8 weeks of screening, eligible participants are randomized into a 12‑week double‑blind core treatment taking oral study tablets twice daily with a 7‑day dose‑escalation, then a 40‑week extension period (placebo participants switch to active drug) and a 4‑week follow‑up after the last dose. Study visits include regular safety checks, blood tests (including blood sampling for pharmacokinetics), ulcer counts and pain scoring, eye examinations, ECGs, disease‑activity and quality‑of‑life questionnaires, and monitoring for adverse events. Investigators may adjust dosing for intolerance. Participants who stop treatment prematurely are still followed for safety for 4 weeks after their last dose.
How the study is structured. A Phase 3 interventional drug trial with 1:1:1 randomization to Hemay005 45 mg BID, Hemay005 60 mg BID, or placebo. Triple-masked, parallel-group design. Core treatment is 12 weeks (with a 7-day dose-titration), then a 40-week extension in which all participants receive active drug (placebo-group participants are re-randomized 1:1 to the two doses), and a final 4-week safety observation after the last dose. Repeated visits collect efficacy, safety, and blood samples for population pharmacokinetics (measured at specified weeks).
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- Some participants receive a placebo. How is that decided, and what happens for placebo-group participants when the study ends?
- The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on Behçet's disease
This trial is also listed on this site under familial Mediterranean fever.
Important dates
- Study start
- Nov 13, 2023
- Primary completion
- May 30, 2026 (estimated)
- Study completion
- Jun 30, 2026 (estimated)
- Target enrollment
- 162 participants (estimated)
- Last updated on registry
- Apr 8, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Ganzhou Hemay Pharmaceutical Co., Ltd
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Jinfeng Lin 📞 15790249669 ✉ linjinfeng@hemay.com.cn
Participating sites (22)
- Beijing Friendship hospital capital medical hospitalRecruiting
Beijing, Beijing Municipality · China
- Yanying Liu
- Peking university first hospitalRecruiting
Beijing, Beijing Municipality · China
- ZhuoLi Zhang
- Peking University People's HospitalRecruiting
Beijing, Beijing Municipality · China
- Zhanguo Li, Dortor
- Peking university third hospitalRecruiting
Beijing, Beijing Municipality · China
- RONG MU
- Xuanwu hospital capital medical universityRecruiting
Beijing, Beijing Municipality · China
- Yi Zhao
- The first affiliated hospital of Xiamen UniversityRecruiting
Xiamen, Fujian · China
- Guixiu Shi
- Guangdong second provincial central hospitalRecruiting
Guangzhou, Guangdong · China
- Weiming Deng
- Sun Yat-Sen memorial hospitalRecruiting
Guangzhou, Guangdong · China
- Lie Dai
- The third affiliated hospital sun yat-sen universityRecruiting
Guangzhou, Guangdong · China
- Yunfeng Pan
- The university of Hong Kong-Shenzhen HospitalRecruiting
Shenzhen, Guangdong · China
- Ling Wu
Terms used on this page · explanations by MedicalUpdates.ai
- randomized
- Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
- placebo-controlled
- A study design in which one group receives a placebo so that the study treatment's effects can be compared with no active treatment.
- double-blind
- Two types of people involved in the study do not know which intervention a participant is receiving. The ClinicalTrials.gov record specifies who is masked, for example participants, care providers, investigators or outcome assessors.
- parallel-group
- Participants are divided into two or more groups, and each group receives a different intervention at the same time, so the groups can be compared.
- placebo
- A treatment that looks like the study treatment but contains no active ingredient. Some participants receive it instead of the study treatment, usually without knowing which they got.
- follow up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
- Informed Consent Form
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- women of childbearing potential
- Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
- immunosuppressive
- A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
- refractory
- A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
- 12-lead ECG
- A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
- prior to screening
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- 5 half-lives
- The time it takes for the amount of a drug in the body to fall by half. 'Five half-lives' is often used as the point at which a previous drug has essentially left the body.
- corticosteroid
- Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
- pharmacokinetic
- How the body absorbs, distributes, breaks down and removes a drug. It is studied by measuring drug levels or related substances at set times after a dose.
- pharmacodynamic
- What a drug does to the body, for example how it changes a blood marker or a symptom, and how that relates to the dose.
- ULN
- The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
- CT
- An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
- relapse
- A condition that improved with treatment and has since returned or worsened.
- investigational product
- A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- extension period
- A continuation study in which participants who completed an earlier study can keep receiving the treatment, usually with everyone knowing what they are given.
- baseline
- Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
- eligibility criteria
- The rules the study team uses to decide who may take part. They are usually split into inclusion criteria and exclusion criteria.
- 1:1
- How many participants go to each group. In a 2:1 ratio, two are assigned to the first group for every one assigned to the second.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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