Brief 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. 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.

Trial Health

Monitor

Trial Health Score

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

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Nov 2020

Shorter than P25 for phase_2

Geographic Reach

1 country

31 active sites

Status

terminated

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

1.4 years study duration

First Submitted

Initial submission to the registry

October 19, 2020

Completed

11 days until next milestone

First Posted

Study publicly available on registry

October 30, 2020

Completed

1 month until next milestone

Study Start

First participant enrolled

November 30, 2020

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed

Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

1.4 years

First QC Date

October 19, 2020

Last Update Submit

June 15, 2022

Conditions

Behçet Disease

Keywords

Behçet Disease

Outcome Measures

Primary Outcomes (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
week 12

Secondary Outcomes (23)

Proportion of subjects achieving an oral ulcer complete response
week 6
Complete response rate for oral ulcers
day 3, day 7 and week12
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)
week12
change of the number of oral ulcers
week12
Time to oral ulcer resolution
week12
+18 more secondary 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 12 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 12 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 12 weeks.

Drug: Hemay005Other: Placebo

Interventions

Hemay005DRUG

Hemay005 tables 60mg bid p.o;

Also known as: Phosphodiesterase 4 (PDE4) inhibitors

Hemay005 high dose groupPlacebo

PlaceboOTHER

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:

Understand and voluntarily sign an informed consent form prior to any study related assessments/procedures being conducted.
Male and female subjects 18\~75(inclusive) years of age at the time of signing the informed consent form.
Diagnosed with Behçet's disease meeting the International Study Group (ISG) criteria (2013).
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.
\. 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.
All females of childbearing potential (FCBP) and male subjects who did not receive the vasectomy must take effective contraceptive measures.

You may not qualify if:

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
\. 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;
\. subjects who current receiving immunotherapy including:
days prior to Visit 2 (randomization) for colchicine.
days prior to Visit 2 (randomization) for azathioprine, mycophenolate mofetil, baricitinib or Tofacitinib.
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.
Having received intra-articular or parenteral corticosteroids within 6 weeks (42 days) prior to Visit 2.
Laboratory examination of V1 in screening period:
+14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Tianjin Hemay Pharmaceutical Co., Ltdlead

Study Sites (31)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Location

Anhui provincial hospital

Hefei, Anhui, China

Location

Beijing hospital