What is Hemay005 studying for Behçet's disease?

Hemay005 is being studied to evaluate its effects on treating Behçet's disease, focusing on reducing oral ulcers and other symptoms. The study aims to compare two doses of Hemay005 with placebo to assess safety and efficacy. Ganzhou Hemay Pharmaceutical Co., Ltd is sponsoring this research to better understand treatment options.

Who may be eligible for this Behçet's disease clinical trial?

Adults aged 18 to 75 years with a confirmed diagnosis of Behçet's disease and at least two oral ulcers may be eligible. Both men and women can participate if they meet health and treatment criteria. Please review eligibility criteria for more details.

Is there any cost to participate in this Behçet's disease clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel needs.

Actively Recruiting

Phase 3

Age: 18Years - 75Years

All Genders

ID06145893

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

Led by Ganzhou Hemay Pharmaceutical Co., Ltd · Updated on 2025-04-08

162

Participants Needed

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the efficacy and safety of Hemay005 tablets in patients with Behçet's disease through a phase 3, multi-center, randomized, placebo-controlled, double-blind study. The trial compares high and low doses of Hemay005 against placebo to better understand treatment effects in this condition. The study includes adults aged 18 to 75 years diagnosed with Behçet's disease and experiencing oral ulcers. Participants are randomly assigned to one of three groups: Hemay005 60 mg twice daily, Hemay005 45 mg twice daily, or placebo, during a 12-week core treatment phase. After this, all participants enter a 40-week extension phase where those initially receiving placebo are re-randomized to one of the two Hemay005 doses. Dose escalation occurs during the first week of treatment periods to reduce side effects. Following treatment, a 4-week observation period monitors drug discontinuation effects. Throughout the study, participants undergo regular assessments including oral and genital ulcer evaluations, pain scales, joint and skin lesion assessments, gastrointestinal activity monitoring, eye symptom checks, quality of life questionnaires, and laboratory tests. Safety is closely monitored by tracking adverse events and lab results over the course of treatment and follow-up. The primary outcome focuses on the efficacy related to oral ulcers at week 12, with continued efficacy and safety evaluations throughout the study duration.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

Understanding and voluntarily signing the informed consent form
Age 18 to 75 years, male or female
Diagnosed with Behçet's disease based on ICBD-2013 criteria
At least 2 oral ulcers present at screening (V1) and either at least 2 oral ulcers at randomization (V2) if 14-56 days after V1, or at least 3 oral ulcers at V2 if 0-13 days after V1
Oral ulcers are severe enough to require systemic treatment as determined by the investigator
Women of childbearing potential and men without vasoligation must use effective contraception during the study and for 3 months after last dose
Ability to comply with follow-up schedule and protocol requirements

You will not qualify if you...

Active Behçet's disease lesions in major organs requiring immunosuppressive treatment
Significant heart disease or ECG abnormalities within 6 months prior to screening
Recent use of certain immunomodulatory therapies within specified time frames before randomization
Recent corticosteroid treatment prior to randomization (except glucocorticoid eye drops under conditions)
Use of Chinese patent medicines with immunomodulatory effects within 2 weeks prior to randomization
Abnormal lab values including low hemoglobin, abnormal white blood cell or platelet counts, elevated creatinine, bilirubin, or liver enzymes
Use of potent cytochrome P450 enzyme inducers within 4 weeks prior to randomization
Other autoimmune or chronic inflammatory diseases
Active or recurrent infections considered a safety risk
Significant chest X-ray or CT abnormalities
History of transplantation or immunodeficiency
Positive HIV or syphilis tests
Current or recent history of malignant tumors except certain treated skin or cervical cancers
Use of investigational products within 4 weeks before randomization
Known allergy to study drug or components
History of substance abuse or psychiatric disorder
Conditions interfering with oral drug absorption
Prior use of apremilast
Pregnant or breastfeeding females
Serious uncontrolled diseases that pose risk or affect study results

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

Your Study Journey

Screening

Duration - Up to 8 weeks

Participants are screened for eligibility to participate in the trial.

1 screening visit

Treatment

Duration - 12 weeks

Participants receive escalating doses of Hemay005 tablets or placebo for 7 days, followed by continuous treatment for 12 weeks.

Visits at baseline, weekly visits during first 12 weeks

Treatment

Duration - 40 weeks

Participants continue Hemay005 tablets treatment for 40 weeks during the extension period. Participants initially receiving placebo are re-randomized to Hemay005 with dose titration during the first week of this period.

Visits during extension treatment period with dose titration in first week for some participants

Follow-up

Duration - 4 weeks

Participants are observed for 4 weeks after the last dose of study medication for safety and tolerability.

1 to 2 visits during follow-up observation