Trial · NCT03816891
Outcomes39
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 39
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 2a & 2b: Percent Change From Baseline in Weekly Average Worst Itch-Numeric Rating Scale (WI-NRS) Score | at Week 8 (Phase 2a); at Week 16 (Phase 2b) | Modified Intent to Treat (mITT) Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Part 2a: Last Observation Carried Forward (LOCF); Part 2b: Multiple imputation (WI) | percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS at Week 8 | Baseline, Week 8 | mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period; LOCF. | percentage of participants | NUMBER |
| SECONDARY | Phase 2a: Percent Change From Baseline in Pruritus Visual Analog Scale (VAS) at Week 8 | Baseline, Week 8 | mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period; LOCF. | percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Baseline through Week 16: LOCF; Weeks 17-24: participants with an assessment at given time point. | score on a scale | MEAN |
| SECONDARY | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Baseline through Week 16: LOCF; Weeks 17-24: participants with an assessment at given time point. | percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 18, 20, 24 | mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Baseline through Week 8: LOCF; Weeks 9-24: participants with an assessment at given time point. | units on a scale | MEAN |
| SECONDARY | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 18, 20, 24 | mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Baseline through Week 8: LOCF; Weeks 9-24: participants with an assessment at given time point. | percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Phase 2a: Change From Baseline in 5-D Pruritus Total Score Over Time | Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24 | mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Baseline through Week 8: LOCF; Weeks 10-24: participants with an assessment at given time point. | score on a scale | MEAN |
| SECONDARY | Phase 2a: Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24 | mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Baseline through Week 8: LOCF; Weeks 10-24: participants with an assessment at given time point. | percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period; Baseline through Week 16: LOCF; Weeks 17-24: participants with an assessment at given time point. | percentage of participants | NUMBER |
| SECONDARY | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 20, 24 | mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Baseline through Week 8: LOCF; Weeks 9-24: participants with an assessment at given time point. | units on a scale | MEAN |
| SECONDARY | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 20, 24 | mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Baseline through Week 8: LOCF; Weeks 9-24: participants with an assessment at given time point. | percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Baseline through Week 16: LOCF; Weeks 17-24: participants with an assessment at given time point. | units on a scale | MEAN |
| SECONDARY | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Baseline through Week 16: LOCF; Weeks 17-24: participants with an assessment at given time point. | percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Baseline through Week 16: LOCF; Weeks 17-24: participants with an assessment at given time point. | units on a scale | MEAN |
| SECONDARY | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Baseline through Week 16: LOCF; Weeks 17-24: participants with an assessment at given time point. | percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Phase 2a: Change From Baseline in Quality of Life (QoL) Measure Dermatology QoL Index (DLQI) Over Time | Baseline, Weeks 2, 4, 6, 8, 12, 16, 24 | mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Baseline through Week 8: LOCF; Weeks 12-24: participants with an assessment at given time point. | score on a scale | MEAN |
| SECONDARY | Phase 2a: Percent Change From Baseline in QoL Measure DLQI Over Time | Baseline, Weeks 2, 4, 6, 8, 12, 16, 24 | mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Baseline through Week 8: LOCF; Weeks 12-24: participants with an assessment at given time point. | percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Phase 2a: Change From Baseline in QoL Measure Itchy Quality of Life (ItchyQoL) Over Time | Baseline, Weeks 2, 4, 6, 8, 12, 16, 24 | mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Baseline through Week 8: LOCF; Weeks 12-24: participants with an assessment at given time point. | units on a scale | MEAN |
| SECONDARY | Phase 2a: Percent Change From Baseline in QoL Measure Itchy QoL Over Time | Baseline, Weeks 2, 4, 6, 8, 12, 16, 24 | mITT Analysis Set: All randomized participants who receive at least 1 dose of vixarelimab or placebo and have at least 1 post-baseline efficacy assessment in the double-blind treatment period. Baseline through Week 8: LOCF; Weeks 12-24: participants with an assessment at given time point. | percentage change | 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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