Trial · NCT04609397
A Study to Evaluate the Efficacy and Safety of Hemay005 in the Treatment of Behçet Disease
NCT04609397, Phase 2, Terminated, Tianjin Hemay Pharmaceutical Co., Ltd
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Efficacy and Safety of Hemay005 in the Treatment of Behçet Disease. Trials, record NCT04609397. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04609397
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of Hemay005 in the Treatment of Behçet Disease
- NCT number
- NCT04609397
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 89 participants, actual
- Lead sponsor
- Tianjin Hemay Pharmaceutical Co., Ltd
- Conditions
- Behçet Disease
- Interventions
- Hemay005, Hemay005, Placebo
- First posted
- 2020-10-30
- Last updated
- 2022-06-21
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | to evaluate the efficacy of Hemay005 in the treatment of Behçet's disease. | week 12 | Area under the curve (AUC) for the number of oral ulcers from baseline through Week 12 |
| Secondary | Proportion of subjects achieving an oral ulcer complete response | week 6 | 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 |
| Secondary | Complete response rate for oral ulcers | day 3, day 7 and week12 | Complete response rate for oral ulcers at day 3, day 7 and Week 12 |
| Secondary | 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 from baseline in the pain of oral ulcers as measured by VAS at Week 12 |
| Secondary | change of the number of oral ulcers | week12 | Change from baseline in the number of oral ulcers at Week 12 |
| Secondary | Time to oral ulcer resolution | week12 | Time to oral ulcer resolution (complete response) that the first instance when a subject has a complete response during the core-Treatment Phase |
| Secondary | Proportion of subjects achieving an oral ulcer complete response in the core-treatment phase | week12 | Proportion of subjects achieving an oral ulcer complete response (oral ulcer-free) and who remain oral ulcer free during the core-treatment Phase |
| Secondary | Number of oral ulcers who has a reappearance during the core-treatment phase | week12 | 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 |
| Secondary | Time to oral ulcer reappearance during the core-treatment | week12 | 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 |
| Secondary | change of the total score of Physician's Global Assessment(PGA) | week12 | 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 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41748391 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04609397
GET https://conductscience.org/api/trials/v1/NCT04609397/registered?page=2