Trial · NCT06145893
A Study of Efficacy and Safety of Hemay005 Tablets in Patients With Behçet's Disease
NCT06145893, Phase 3, Recruiting, Ganzhou Hemay Pharmaceutical Co., Ltd
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Efficacy and Safety of Hemay005 Tablets in Patients With Behçet's Disease. Trials, record NCT06145893. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06145893
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Efficacy and Safety of Hemay005 Tablets in Patients With Behçet's Disease
- NCT number
- NCT06145893
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 162 participants, estimated
- Lead sponsor
- Ganzhou Hemay Pharmaceutical Co., Ltd
- Conditions
- Behçet's Disease
- Interventions
- Hemay005, Hemay005, Placebo
- First posted
- 2023-11-24
- Last updated
- 2025-04-08
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy assessed by oral ulcers | week 12 | Area under the curve (AUC) of the number of oral ulcers in BD patients from baseline to Week 12 |
| Secondary | efficacy assessed by oral ulcers | week 12, 22, 32, 42, 52 | Complete response rate for oral ulcers at Week 12,22,32,42,52; A complete response is defined as the proportion of subjects who are oral ulcer free |
| Secondary | pain of oral ulcers assessed by VAS | week 12, 22, 32, 42, 52 | Change from baseline in the pain of oral ulcers as measured by VAS at Week 12,22,32,42,52 |
| Secondary | efficacy assessed by genital ulcers | week 12, 22, 32, 42, 52 | Complete response rate for genital ulcers at Week 12,22,32,42,52 for subjects who had genital ulcers at Baseline; A complete response is defined as the proportion of subjects who are genital ulcer-free |
| Secondary | pain of genital ulcers assessed by VAS | week 12, 22, 32, 42, 52 | Change from baseline in the pain of genital ulcers, as measured by VAS at Week 12,22,32,42,52 in subjects who had genital ulcers at baseline |
| Secondary | efficacy assessed by BDCAF | week 12, 22, 32, 42, 52 | Change from baseline in disease activity as measured by Behçet's Disease Current Activity scores (BD Current Activity Form) at Week 12,22,32,42,52 |
| Secondary | efficacy assessed by BSAS | week 12, 22, 32, 42, 52 | Change from Baseline in Behçet's Syndrome Activity Score (BSAS) at Week 12,22,32,42,52 |
| Secondary | efficacy assessed by oral ulcers | week 1, 2, 4, 6, 8, 10, 12 | Time to oral ulcer resolution (complete response), ie, the first instance when a subject has a complete response, during the Placebo-controlled Treatment Phase |
| Secondary | efficacy assessed by oral ulcers | week 1, 2, 4, 6, 8, 10, 12 | Proportion of subjects with no oral ulcers following complete response, ie, the first time when a subject has a complete response, during the Placebo-controlled Treatment Phase |
| Secondary | efficacy assessed by oral ulcers | week 1, 2, 4, 6, 8, 10, 12 | Number of oral ulcers following loss of complete response, ie, the first instance when a subject has a reappearance of oral ulcers following a complete response, during the Placebo-controlled Treatment Phase |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT06145893
GET https://conductscience.org/api/trials/v1/NCT06145893/registered?page=2