Trial · NCT04609397
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| 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 |
| Secondary | change of BD Current Activity Form(BDCAF) | week12 | change from baseline in the total score of the BDCAF questionnaire at week 12 |
| Secondary | change of Multi-Dimensional Health Assessment Questionnaire (MDHAQ) | week12 | change from baseline in the total score of the MDHAQ questionnaire at week 12 |
| Secondary | change of short from health survey(SF-36) | week12 | change from baseline in the total score of the SF-36 questionnaire at week 12 |
| Secondary | Complete response rate for genital ulcers | week12 | Complete response rate for genital ulcers at Week 12 for subjects who had genital ulcers at Baseline |
| Secondary | change of the pain evaluation of genital ulcers | week12 | Change from baseline in the pain of genital ulcers as measured by VAS at Week 12 |
| Secondary | Change of the Behçet's syndrome activity score(BSAS) score | week12 | Change from Baseline in BSAS score at Week 12 |
| Secondary | Maximum Plasma Concentration (Cmax) | week24 | the population pharmacokinetic (popPK) characteristics Cmax of Hemay005 in BD patients |
| Secondary | Minimum Plasma Concentration (Cmin) | week24 | the population pharmacokinetic (popPK) characteristics Cmin of Hemay005 in BD patients |
| Secondary | Time to peak (Tmax) | week24 | the population pharmacokinetic (popPK) characteristics Tmax of Hemay005 in BD patients |
| Secondary | Elimination half-life (T1/2) | week24 | the population pharmacokinetic (popPK) characteristics T1/2 of Hemay005 in BD patients |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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