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Behçet DiseasePhase 2NCT04609397

A Study to Evaluate the Efficacy and Safety of Hemay005 in the Treatment of Behçet Disease

A Phase 2 study testing Hemay005 in people with Behçet Disease, run by Tianjin Hemay Pharmaceutical Co., Ltd at 31 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a phase 2, 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Behçet Disease
What is being tested?
Hemay005
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
89 participants
Where
31 sitesChina
Study dates
30 Nov 2020to 30 Apr 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1.Understand and voluntarily sign an informed consent form prior to any study related assessments/procedures being conducted.
  • 2.Male and female subjects 18~75(inclusive) years of age at the time of signing the informed consent form.
  • 3.Diagnosed with Behçet's disease meeting the International Study Group (ISG) criteria (2013).
  • 4.Subjects must have at least 2 oral ulcers at V1, and:
  • at least 2 oral ulcers at V2 if V2 occurs at least 14 days after Visit 1, OR
  • at least 3 oral ulcers at V2 if V2 occurs at least 0~42 days after Visit 1.
  • 5. According to the site investigator judgement, subject is suitable to the systemic but not topical treatment of oral ulcer considering the severity and affected area of the disease OR the oral ulcer cannot be well controlled by topical treatment and have to take the systemic treatment.
  • 6.All females of childbearing potential (FCBP) and male subjects who did not receive the vasectomy must take effective contraceptive measures.

Who cannot join

  • 1.subject has the BD related major organ activity lesions requiring immunosuppressive therapy- pulmonary, vascular, gastrointestinal, and central nervous systems (eg, meningoencephalitis) manifestations, etc. However:
  • Previous major organ involvement is allowed if it occurred at least one years prior to screening visit and is not active at time of enrollment.
  • Subjects with BD-related arthritis and BD-skin manifestations are also allowed
  • 2. Any clinically significant heart disease (e.g., but not limited to unstable ischemic heart disease, New York Heart Association(NYHA) class III / IV left ventricular failure, or myocardial infarction) or clinically significant 12 lead ECG abnormalities found during screening, which, according to the investigator's judgment, may put the patient at safety risk or may interfere with the investigator;
  • 3. subjects who current receiving immunotherapy including:
  • 7 days prior to Visit 2 (randomization) for colchicine.
Show all 29Show fewer
  • 10 days prior to Visit 2 (randomization) for azathioprine, mycophenolate mofetil, baricitinib or Tofacitinib.
  • 4 weeks prior to visit 2(randomization) for cyclosporin, methotrexate, cyclophosphamide, thalidomide, and dapsone.
  • At least 5 terminal half-lives for all biologics, including,within:
  • Four weeks prior to visit 2(randomization) for etanercept.
  • Eight weeks prior to visit 2(randomization) for infliximab.
  • Ten weeks prior to visit 2(randomization) for adalimumab, golimumab, abatacept, and tocilizumab.
  • Six months prior to visit 2(randomization) for secukinumab.
  • 4.Having received intra-articular or parenteral corticosteroids within 6 weeks (42 days) prior to Visit 2.
  • 5.Laboratory examination of V1 in screening period:
  • Hemoglobin ≤ 85g / L;
  • The white blood cell (WBC) count was less than 3.0 × 10^9 / L or more than 14 × 10^9 / L;
  • Platelet < 100 × 10^9 / L;
  • Serum creatinine > 1.5mg/dl (> 132.6 μ mol / L);
  • Total bilirubin > 2.0 mg / dl (> 34.2 μ mol / L);
  • The Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) were higher than 1.5 times of the upper limit of normal value.
  • 6.subjects who received strong cytochrome P450 enzyme inducer within 4 weeks prior to visit2.
  • 7.Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (including but not limited to tuberculosis and atypical mycobacterial disease, hepatitis B and C and herpes zoster, histoplasmosis, coccidiomycosis, but excluding onychomycosis) , judged by investigator,may put the patient at safety risk.
  • 8.Clinically significant abnormality on chest radiograph or CT,judged by investigator, may put the patient at safety risk.
  • 9.History of transplantation and immunodeficiency disease, including those subject has a positive test for human immunodeficiency virus (HIV).
  • 10.subject who use of any investigational products of clinical trials within 4 weeks or within 5 pharmacokinetic/pharmacodynamic half-lives prior to randomization, whichever is longer;
  • 11.known to be allergic or allergic to the investigational products or ingredients;
  • 12.History of alcohol or drug abuse, or a history of mental illness;
  • 13.Subjects with severe, progressive, or uncontrolled disease, judged by the investigator, who maybe at risk if participate this study or those subjects whose participation may influence the interpretation of study results.

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

China31 sites

  • The First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of science and technology

    Baotou, Inner Mongolia

  • Beijing hospital

    Beijing, Beijing Municipality

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality

  • Peking University First Hospital

    Beijing, Beijing Municipality

  • Peking University People's Hospital

    Beijing, Beijing Municipality

  • Peking University Shougang Hospital

    Beijing, Beijing Municipality

  • Xuanwu Hospital Capital Medical University

    Beijing, Beijing Municipality

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin

  • Jilin Provincial People's Hospital

    Changchun, Jilin

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

  • The First Affiliated Hospital of Chengdu Medical College

    Chengdu, Sichuan

  • Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University

    Guangzhou, Guangdong

  • First Affiliated Hospital，Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang

  • Anhui provincial hospital

    Hefei, Anhui

  • Jiu Jiang NO.1 people's Hospital

    Jiujiang, Jiangxi

  • Linyi people's Hospital

    Linyi, Shandong

  • Jiangsu Provincial Hospital

    Nanjing, Jiangsu

  • Jiangxi Pingxiang people's Hospital

    Pingxiang, Jiangxi

  • Huashan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality

  • Tongji Hospital Of Tongji University Tang Jianping

    Shanghai, Shanghai Municipality

  • Zhongshan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality

  • The University of Hong Kong-Shenzhen Hospital

    Shenzhen, Guangdong

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi, Xinjiang

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

Official title: A Phase Ⅱ Study to Evaluate the Efficacy and Safety of Hemay005 in the Treatment of Behçet Disease

This is a phase 2, 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 12weeks and a follow up phase for 4weeks.

Read the detailed description

this study is a phase 2, multi-center, randomized, placebo-controlled, double-blind, parallel-group study to evaluate Hemay005 efficacy and safety of the treatment of patients with Behçet Disease(BD). Around 252 subjects will be randomized into this study.

The whole study will including 4 phases that a screening phase, core-treatment phase(12weeks), extended-treatment phase (12weeks) and follow-up phase(4 weeks).

Screening: All subjects will undergo a screening period of up to 6 weeks prior to baseline visit (visit 2, day of randomization, Day0).

Core treatment phase: eligible BD patients will randomly assigned to Hemay005 high-dose group, Hemay005 low-dose group, placebo (core treatment phase) + Hemay005 high-dose group (extended treatment phase), or placebo (core treatment phase) + Hemay005 low-dose group (extended treatment phase). During the core-treatment period, hemay005 will be administered twice daily for 12 weeks. The randomization was stratified to minimize the imbalance between treatment groups.

Extended treatment phase: Subjects in the high-dose and low-dose groups during the extended treatment period will still given the dose of core-treatment phase for 12 weeks. Subjects who received placebo during the core treatment will assigned to either a high-dose group or a low-dose group according the allocation at visit 2 until 12 weeks after. During this period, the subject and investigator are remain blind at this stage.

Follow up phase: Subjects in the study (also including those who withdraw from treatment for any reason) will have another follow up for 4 weeks after the end of the last administration.

Conditions
Behçet Disease
Being tested
Hemay005, Placebo
Keywords
Behçet Disease
Medical subject headings
Behcet Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hemay005Drug

    Also called Phosphodiesterase 4 (PDE4) inhibitors

    Hemay005 tables 60mg bid p.o;

  • Hemay005Drug

    Also called Phosphodiesterase 4 (PDE4) inhibitors

    Hemay005 tables 45mg bid p.o

  • PlaceboOther

    placebo to Hemay005 tables bid p.o

Study groups in NCT04609397
Study groupRoleWhat they receive
Hemay005 high dose groupExperimentalIn 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 12 weeks.
Receives: Drug: Hemay005
Hemay005 lower dose groupExperimentalIn 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 12 weeks.
Receives: Drug: Hemay005
PlaceboPlacebo comparatorIn 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 12 weeks.
Receives: Drug: Hemay005; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. to evaluate the efficacy of Hemay005 in the treatment of Behçet's disease.

    Area under the curve (AUC) for the number of oral ulcers from baseline through Week 12

    Measured: week 12

Secondary outcomes (23)

  1. Proportion of subjects achieving an oral ulcer complete response

    Proportion of subjects achieving an oral ulcer complete response (oral ulcer-free) by Week 6 after dosing, and who remain oral ulcer free for at least 6 additional weeks during the Treatment Phase

    Measured: week 6

  2. Complete response rate for oral ulcers

    Complete response rate for oral ulcers at day 3, day 7 and Week 12

    Measured: day 3, day 7 and week12

  3. change of the pain evaluation of oral ulcers as measured by Visual analogue scale(VAS)(From 0-100, the higher score means the worse outcome)

    Change from baseline in the pain of oral ulcers as measured by VAS at Week 12

    Measured: week12

  4. change of the number of oral ulcers

    Change from baseline in the number of oral ulcers at Week 12

    Measured: week12

  5. Time to oral ulcer resolution

    Time to oral ulcer resolution (complete response) that the first instance when a subject has a complete response during the core-Treatment Phase

    Measured: week12

  6. Proportion of subjects achieving an oral ulcer complete response in the core-treatment phase

    Proportion of subjects achieving an oral ulcer complete response (oral ulcer-free) and who remain oral ulcer free during the core-treatment Phase

    Measured: week12

  7. Number of oral ulcers who has a reappearance during the core-treatment phase

    Number of oral ulcers following loss of complete response that the first instance when a subject has a reappearance of oral ulcers following a complete response during the core-Treatment Phase

    Measured: week12

  8. Time to oral ulcer reappearance during the core-treatment

    Time to recurrence of oral ulcers following loss of complete response that the first instance when a subject has a reappearance of oral ulcers following a complete response during the core-Treatment Phase

    Measured: week12

  9. change of the total score of Physician's Global Assessment(PGA)

    change from baseline in the total score of the PGA of skin lesions of BD at week 12 in those subjects who had at baseline

    Measured: week12

  10. change of BD Current Activity Form(BDCAF)

    change from baseline in the total score of the BDCAF questionnaire at week 12

    Measured: week12

  11. change of Multi-Dimensional Health Assessment Questionnaire (MDHAQ)

    change from baseline in the total score of the MDHAQ questionnaire at week 12

    Measured: week12

  12. change of short from health survey(SF-36)

    change from baseline in the total score of the SF-36 questionnaire at week 12

    Measured: week12

  13. Complete response rate for genital ulcers

    Complete response rate for genital ulcers at Week 12 for subjects who had genital ulcers at Baseline

    Measured: week12

  14. change of the pain evaluation of genital ulcers

    Change from baseline in the pain of genital ulcers as measured by VAS at Week 12

    Measured: week12

  15. Change of the Behçet's syndrome activity score(BSAS) score

    Change from Baseline in BSAS score at Week 12

    Measured: week12

  16. Maximum Plasma Concentration (Cmax)

    the population pharmacokinetic (popPK) characteristics Cmax of Hemay005 in BD patients

    Measured: week24

  17. Minimum Plasma Concentration (Cmin)

    the population pharmacokinetic (popPK) characteristics Cmin of Hemay005 in BD patients

    Measured: week24

  18. Time to peak (Tmax)

    the population pharmacokinetic (popPK) characteristics Tmax of Hemay005 in BD patients

    Measured: week24

  19. Elimination half-life (T1/2)

    the population pharmacokinetic (popPK) characteristics T1/2 of Hemay005 in BD patients

    Measured: week24

  20. Area under drug time curve (AUC)

    the population pharmacokinetic (popPK) characteristics AUC of Hemay005 in BD patients

    Measured: week24

  21. Clearance (Cl)

    the population pharmacokinetic (popPK) characteristics Cl of Hemay005 in BD patients

    Measured: week24

  22. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])

    the Incidence of Treatment-Emergent Adverse Events of Hemay005 in BD patients with different dosing group

    Measured: week24

  23. the number of subjects who terminated hemay005 prematurely due to adverse events (AE) [Safety and Tolerability])

    the number of subjects who terminated hemay005 prematurely due to adverse events (AE) in BD patients with different dosing group

    Measured: week24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2020
  2. Study start30 Nov 2020
  3. Primary completion30 Apr 2022
  4. Study completion30 Apr 2022

Why it stopped: The study purpose has been achieved

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04609397
Sponsor's protocol ID
HM005BD2S01
Status last verified
Jun 2022
First submitted
19 Oct 2020
Last updated
21 Jun 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Liu T, Li C, Zheng W, Tang J, Chen D, Peng Y, Yin S, Zhou D, Zhang Z, Huang C, Dai L, Wei X, Lin J, Yu Y, Wu L, Zhang Z, Liu S, Li X, Jiang L, Wu J, Zhao Y, Chen L, Meng T, Wu L, Wang Y, Wan W, Kong N, Ke Y, Bi L, Li Y, Dang W, Zhang H, Jones R, Li Z. Efficacy and safety of mufemilast in patients with Behcet's syndrome: a phase 2 randomised clinical trial. Ann Rheum Dis. 2026 Jul;85(7):1425-1435. doi: 10.1016/j.ard.2026.01.014. Epub 2026 Feb 25.

    PubMed 41748391

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hemay005 in people with Behçet Disease, run by Tianjin Hemay Pharmaceutical Co., Ltd at 31 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study purpose has been achieved). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

to evaluate the efficacy of Hemay005 in the treatment of Behçet's disease. (time frame: week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04609397, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022; AzTrials last refreshed its copy on 7 Nov 2026.

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