Trial · NCT04517253
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 | Change From Baseline in Mean Daily Diary Scores in Participants With CANDLE (Primary Treatment Period) | Baseline, 20 weeks | CANDLE: All enrolled participants who received at least one dose of study drug. | score on a scale | MEAN |
| PRIMARY | Change From Baseline in Mean Daily Diary Scores in Participants With SAVI (Primary Treatment Period) | Baseline, 32 weeks | SAVI: All enrolled participants who received at least one dose of study drug. | score on a scale | MEAN |
| PRIMARY | Change From Baseline in Mean Daily Diary Scores in Participants With AGS (Primary Treatment Period) | Baseline, 32 weeks | AGS: All enrolled participants who received at least one dose of study drug. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Mean Daily Diary Scores in Participants With CANDLE (Primary Treatment and Maintenance Period) | Baseline, 191.1 weeks | CANDLE: All enrolled participants who received at least one dose of study drug. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Mean Daily Diary Scores in Participants With SAVI (Primary Treatment and Maintenance Period) | Baseline, 202.9 weeks | SAVI: All enrolled participants who received at least one dose of study drug. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Mean Daily Diary Scores in Participants With AGS (Primary Treatment and Maintenance Period) | Baseline, 206.1 weeks | AGS: All enrolled participants who received at least one dose of study drug. | score on a scale | MEAN |
| SECONDARY | Number of Participants With Decrease in Daily Dose of Corticosteroids in Participants With CANDLE, SAVI and AGS (Primary Treatment Period) | CANDLE: Week 20, SAVI and AGS: Week 32 | CANDLE, SAVI and AGS: All enrolled participants who received at least one dose of study drug and took corticosteroids at baseline with evaluable data for this outcome. | participants | NUMBER |
| SECONDARY | Number of Participants With Decrease in Daily Dose of Corticosteroids in Participants With CANDLE, SAVI and AGS (Primary Treatment and Maintenance Period) | CANDLE: Week 191.1; SAVI: 202.9 and AGS: Week 206.1 | CANDLE, SAVI and AGS: All enrolled participants who received at least one dose of study drug and took corticosteroids at baseline with evaluable data for this outcome. | participants | NUMBER |
| SECONDARY | Change From Baseline in Patient's Symptom Specific Daily Diary Scores For Participants With CANDLE (Primary Treatment Period) | Baseline, 20 weeks | CANDLE: All enrolled participants who received at least one dose of study drug. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Patient's Symptom Specific Daily Diary Scores For Participants With SAVI (Primary Treatment Period) | Baseline, 32 weeks | SAVI: All enrolled participants who received at least one dose of study drug. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Patient's Symptom Specific Daily Diary Scores For Participants With AGS (Primary Treatment Period) | Baseline, 32 weeks | AGS: All enrolled participants who received at least one dose of study drug. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Patient's Symptom Specific Daily Diary Scores For Participants With CANDLE (Primary Treatment and Maintenance Period) | Baseline, 191.1 weeks | CANDLE: All enrolled participants who received at least one dose of study drug. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Patient's Symptom Specific Daily Diary Scores For Participants With SAVI (Primary Treatment and Maintenance Period) | Baseline, 202.9 weeks | SAVI: All enrolled participants who received at least one dose of study drug. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Patient's Symptom Specific Daily Diary Scores For Participants With AGS (Primary Treatment and Maintenance Period) | Baseline, 206.1 weeks | AGS: All enrolled participants who received at least one dose of study drug. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the Physician's Global Assessment of Disease Activity Scores in Participants With CANDLE (Primary Treatment Period) | Baseline, 20 weeks | CANDLE: All enrolled participants who received at least one dose of study drug. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the Physician's Global Assessment of Disease Activity Scores in Participants With SAVI and AGS (Primary Treatment Period) | Baseline, 32 weeks | SAVI and AGS: All enrolled participants who received at least one dose of study drug. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the Physician's Global Assessment of Disease Activity Scores in Participants With CANDLE (Primary Treatment and Maintenance Period) | Baseline, 191.1 weeks | CANDLE: All enrolled participants who received at least one dose of study drug. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the Physician's Global Assessment of Disease Activity Scores in Participants With SAVI and AGS (Maintenance Period) | SAVI: Baseline, 202.9 weeks; AGS: Baseline, 206.1 weeks | SAVI and AGS: All enrolled participants who received at least one dose of study drug. | score on a scale | MEAN |
| SECONDARY | Change of Percentage of Days Meeting the Criteria of Participant's Mean Daily Diary Score <0.5 Compared to That in Pre-treatment Period in Participants With CANDLE (Primary Treatment Period) | Pre-treatment period (average of 12-week pre-treatment data), up to 20 weeks | CANDLE: All enrolled participants who received at least one dose of study drug. SAVI and AGS did not have Pre-treatment period data therefore only CANDLE cohort data were collected. | Percentage of Days | MEAN |
| SECONDARY | Change of Percentage of Days Meeting the Criteria of Participant's Mean Daily Diary Score <0.5 Compared to That in Pre-treatment Period in Participants With CANDLE (Primary Treatment and Maintenance Period) | Pre-treatment period (average of 12-week pre-treatment data), up to 191.1 weeks | CANDLE: All enrolled participants who received at least one dose of study drug. SAVI and AGS did not have Pre-treatment period data therefore only CANDLE cohort data were collected. | Percentage of Days | 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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT04517253/outcomes