Trial · NCT04530344
Outcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Relapse (Defined as <F-VASI75) | from Week 52 (first visit of this Treatment Extension study) to Week 104 (end of treatment in this Treatment Extension study) | Intent-to-Treat Long-term Extension (ITT-Ext) Population: randomized participants who achieved ≥90% improvement from Baseline in the F-VASI score (≥F-VASI90) at Week 52. Treatment groups were defined according to the treatment assignment at randomization regardless of the actual study medication the participant received. Week 52 was the first visit of this Treatment Extension study (visits were named to reflect continuation from the parent studies). Only participants in Cohort A were analyzed. | days | MEDIAN |
| SECONDARY | Time to Loss of Adequate Response | from Week 52 (first visit of this Treatment Extension study) to Week 104 (end of treatment in this Treatment Extension study) | ITT-Ext Population. Week 52 was the first visit of this Treatment Extension study (visits were named to reflect continuation from the parent studies). Only participants in Cohort A were analyzed. | days | MEDIAN |
| SECONDARY | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | Full Analysis Set (FAS) without non-compliant site: all participants who received at least 1 dose of study drug at or after Week 52 (Baseline of Treatment Extension study). For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Mean F-VASI Scores During the Extension Treatment Period | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in F-VASI Scores During the Extension Treatment Period | Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed. | scores on a scale | MEAN |
| SECONDARY | Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Baseline (BL); up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed. | percentage change | MEAN |
| SECONDARY | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score During the Extension Treatment Period | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Mean T-VASI Scores During the Extension Treatment Period | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in T-VASI Scores During the Extension Treatment Period | Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed. | scores on a scale | MEAN |
| SECONDARY | Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period | Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed. | percentage change | MEAN |
| SECONDARY | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed. | percentage BSA | MEAN |
| SECONDARY | Change From Baseline in F-BSA During the Extension Treatment Period | Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed. | percentage BSA | MEAN |
| SECONDARY | Percent Change From Baseline in F-BSA During the Extension Treatment Period | Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed. | percentage change | MEAN |
| SECONDARY | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed. | percentage BSA | MEAN |
| SECONDARY | Change From Baseline in T-BSA During the Extension Treatment Period | Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed. | percentage BSA | MEAN |
| SECONDARY | Percent Change From Baseline in T-BSA During the Extension Treatment Period | Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed. | percentage change | MEAN |
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
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GET https://conductscience.org/api/trials/v1/NCT04530344/outcomes