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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

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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

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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.

ListOutcomeTime frameDescription
PrimaryEfficacy assessed by oral ulcersweek 12Area under the curve (AUC) of the number of oral ulcers in BD patients from baseline to Week 12
Secondaryefficacy assessed by oral ulcersweek 12, 22, 32, 42, 52Complete 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
Secondarypain of oral ulcers assessed by VASweek 12, 22, 32, 42, 52Change from baseline in the pain of oral ulcers as measured by VAS at Week 12,22,32,42,52
Secondaryefficacy assessed by genital ulcersweek 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
Secondarypain of genital ulcers assessed by VASweek 12, 22, 32, 42, 52Change 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
Secondaryefficacy assessed by BDCAFweek 12, 22, 32, 42, 52Change 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
Secondaryefficacy assessed by BSASweek 12, 22, 32, 42, 52Change from Baseline in Behçet's Syndrome Activity Score (BSAS) at Week 12,22,32,42,52
Secondaryefficacy assessed by oral ulcersweek 1, 2, 4, 6, 8, 10, 12Time to oral ulcer resolution (complete response), ie, the first instance when a subject has a complete response, during the Placebo-controlled Treatment Phase
Secondaryefficacy assessed by oral ulcersweek 1, 2, 4, 6, 8, 10, 12Proportion 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
Secondaryefficacy assessed by oral ulcersweek 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

Outcomes0

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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