Trial · NCT04157348
Outcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 32
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects Who Achieved Main Remission at Both Weeks 36 and 48 | Week 36 and Week 48 | Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Supportive Endpoint: Proportion of Subjects Who Achieved Supportive Remission at Both Weeks 36 and 48 | Week 36 and Week 48 | Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Total Accrued Duration of Remission During DB Treatment Period | from baseline to end of DB period, 52 Weeks. | Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Total Accrued Duration of Sustained Remission During DB Treatment Period | from baseline to end of DB period, 52 Weeks | Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time From Randomization to First Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse | from baseline to end of DB period, 52 Weeks | Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | percentage of subjects | NUMBER |
| SECONDARY | Annualized Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse Rate | from baseline to end of DB period, 52 Weeks | Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | relapses per year | LEAST_SQUARES_MEAN |
| SECONDARY | Average Daily Dose of Prednisolone/Prednisone and Change From Baseline During Week 48 Through 52 | last 4 weeks of DB period | Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | mg | MEAN |
| SECONDARY | Proportion of Patients With Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | last 4 weeks of DB period | Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | last 4 weeks of DB period | Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Subjects With Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | last 4 weeks of DB period | Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Subjects Who Achieve Clinical Benefit | from baseline to end of DB period, 52 Weeks | Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Patients Who Have Achieved Remission Within the First 24 Weeks and Remained in Remission for Remainder of the Double-blind Treatment Period | from baseline to end of DB period, 52 Weeks | Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Birmingham Vasculitis Activity Score (BVAS) | from baseline to end of DB period, 52 Weeks | Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FEV1 (L) | from baseline to end of DB period, 52 Weeks | Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | L | LEAST_SQUARES_MEAN |
| SECONDARY | Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FVC (L) | from baseline to end of DB period, 52 Weeks | Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Vasculitis Damage Index (VDI) | from baseline to end of DB period, 52 Weeks | Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | score | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6) | from baseline to end of DB period, 52 Weeks | Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | score | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Physical Component Summary (PCS) | from baseline to end of DB period, 52 Weeks | Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | score | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Mental Component Summary (MCS) | from baseline to end of DB period, 52 Weeks | Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | score | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Sino-nasal Outcome Test-22 (SNOT-22) Total Score | from baseline to end of DB period, 52 Weeks | Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | score | LEAST_SQUARES_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.
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