Trial · NCT06145893
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| 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 |
| Secondary | efficacy assessed by oral ulcers | week 1, 2, 4, 6, 8, 10, 12 | Time to recurrence 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 |
| Secondary | efficacy of skin lesions assessed by PGA score | week 12, 22, 32, 42, 52 | Change from baseline in the total score of the Static Physician's Global Assessment (PGA) of skin lesions (acne-like lesions, folliculitis and erythema nodosum) of BD at Week 12，22，32，42，52 in subjects who had BD skin lesions at baseline |
| Secondary | efficacy assessed by oral ulcers | week 2, 4, 6, 8, 10, 12 | Proportion of subjects achieving an oral ulcer complete response (oral ulcer-free) by Week 6, after start of dosing, and who remain oral ulcer free for at least 6 additional weeks during the 12-week Placebo-controlled Treatment Phase |
| Secondary | Quality of life measured by BD QoL | week 12, 22, 32, 42, 52 | Change from baseline in the BD QoL score at Week 12，22，32，42，52 |
| Secondary | Quality of life measured by SF-36 | week 12, 22, 32, 42, 52 | Change from baseline in SF-36 score at Week 12, 22，32，42，52 |
| Secondary | efficacy assessed by tender and/or swollen joints | week 12, 22, 32, 42, 52 | Change from baseline in number of tender and/or swollen joints associated with BD at Week 12，22, 32, 42, and 52 in subjects who had BD-related tender and/or swollen joints at baseline; |
| Secondary | efficacy assessed by gastrointestinal activity | week 12, 22, 32, 42, 52 | Changes from baseline in Disease Activity Index for Intestinal Behçet's Disease (DAIBD) score at Weeks 12, 22, 32, 42, and 52 |
| Secondary | efficacy assessed by gastrointestinal symptoms | week 1, 12, 52 | Changes from baseline in Global GI symptoms assessment at Weeks 12 and 52 |
| Secondary | efficacy assessed by biomarkers. | week 12, 22, 32, 42, 52 | Changes from baseline in CRP and ESR at Weeks 12, 22, 32, 42, and 52; |
| Secondary | efficacy assessed by eye symptoms. | week 12, 22, 32, 42, 52 | Changes from baseline in best corrected visual acuity (BCVA) at Weeks 12, 22, 32, 42, and 52, and changes from baseline in improvement of inflammation (slit lamp and/or ophthalmoscopy/fundus photography optical coherence tomography (OCT), etc.) at Weeks 12 and 52 |
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.
For software
Read this list from software.
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