Trial · NCT02477332
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Complete Hives Response (HSS7=0) | Week 12 | Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. | Percentage of participants | NUMBER |
| SECONDARY | Complete Hives Response (HSS7=0) Rate at Week 12 Measured Over 7 Days | Week 12 | Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups. | Particpants | NUMBER |
| SECONDARY | Change From Baseline in Hives Severity Score (HSS7) at Week 12 Measured Over 7 Days | Week 12 | Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups. | Score on a scale | MEDIAN |
| SECONDARY | HSS7=0 Response: at Week 20 Measured Over 7 Days | Week 20 | Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups. | Participants | NUMBER |
| SECONDARY | Change From Baseline in Hives Severity Score (HSS7) at Week 20 Measured Over 7 Days | Week 20 | Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups. | Score on a scale | MEDIAN |
| SECONDARY | Change From Baseline in Itch Severity Score (ISS7) at Week 12 Measured Over 7 Days | Week 12 | Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups. | Score on a scale | MEDIAN |
| SECONDARY | Change From Baseline in Itch Severity Score (ISS7) at Week 20 Measured Over 7 Days | Week 20 | Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups. | Score on a scale | MEDIAN |
| SECONDARY | Change From Baseline in Urticaria Activity Score (UAS7) at Week 12 Measured Over 7 Days | Week 12 | Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups. | Score on a scale | MEDIAN |
| SECONDARY | Change From Baseline in Urticaria Activity Score (UAS7) at Week 20 Measured Over 7 Days | Week 20 | Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups. | Score on a scale | MEDIAN |
| SECONDARY | Complete Urticaria Activity Score Response (UAS7=0) Rate at Week 12 Measured Over 7 Days | Week 12 | Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups. | Participants | NUMBER |
| SECONDARY | UAS7=0 Response: at Week 20 Measured Over 7 Days | Week 20 | Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups. | participants | NUMBER |
| SECONDARY | Complete Itch Response (ISS7=0) Rate at Week 12 Measured Over 7 Days | Week 12 | Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups. | participants | NUMBER |
| SECONDARY | ISS7=0 Response: at Week 20 Measured Over 7 Days | Week 20 | Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups. | participants | NUMBER |
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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