Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

162

participants targeted

Target at P25-P50 for phase_3

Timeline

2mo left

Started Nov 2023

Typical duration for phase_3

Geographic Reach

1 country

22 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.6 years study duration

Study Progress94%

Nov 2023Jun 2026

Study Start

First participant enrolled

November 13, 2023

Completed

4 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2023

Completed

7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2023

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Expected

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

April 8, 2025

Status Verified

December 1, 2024

Enrollment Period

2.5 years

First QC Date

November 17, 2023

Last Update Submit

April 6, 2025

Conditions

Behçet's Disease

Keywords

Behçet's Disease

Outcome Measures

Primary Outcomes (1)

Efficacy assessed by oral ulcers
Area under the curve (AUC) of the number of oral ulcers in BD patients from baseline to Week 12
week 12

Secondary Outcomes (28)

efficacy assessed by oral ulcers
week 12, 22, 32, 42, 52
pain of oral ulcers assessed by VAS
week 12, 22, 32, 42, 52
efficacy assessed by genital ulcers
week 12, 22, 32, 42, 52
pain of genital ulcers assessed by VAS
week 12, 22, 32, 42, 52
efficacy assessed by BDCAF
week 12, 22, 32, 42, 52
+23 more secondary outcomes

Other Outcomes (4)

efficacy assessed by oral and genital ulcers
week 12
efficacy assessed by genital ulcers
week 1, 2, 4, 6, 8, 10, 12
efficacy assessed by genital ulcers
week 1, 2, 4, 6, 8, 10, 12
+1 more other outcomes

Study Arms (3)

Hemay005 high dose group

EXPERIMENTAL

In Core-treatment period, subject will take Hemay005 60mg twice daily for 12 weeks, and in the following extend-treatment period, subject will take Hemay005 60mg twice daily for 40 weeks.

Drug: Hemay005

Hemay005 lower dose group

EXPERIMENTAL

In Core-treatment period, subject will take Hemay005 45mg twice daily for 12 weeks, and in the following extend-treatment period, subject will take Hemay005 45mg twice daily for 40 weeks.

Drug: Hemay005

Placebo

PLACEBO COMPARATOR

In Core-treatment period, subject will take placebo for 12 weeks, and in the following extend-treatment period, subject will take Hemay005 60mg or hemay005 45mg twice daily according to pre-allocation at randomization visit for 40 weeks.

Drug: Placebo

Interventions

Hemay005DRUG

Hemay005 tables 60mg bid p.o;

Also known as: Mufemilast, Phosphodiesterase 4 (PDE4) inhibitors

Hemay005 high dose group

PlaceboDRUG

placebo to Hemay005 tables bid p.o

Placebo

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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
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.

You may not qualify if:

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;
+19 more criteria

Contact the study team to confirm eligibility.