Trial · NCT03816891
Study to Assess the Efficacy, Safety, and Tolerability of Vixarelimab in Reducing Pruritus in Prurigo Nodularis
NCT03816891, Phase 2, Completed, Genentech, Inc.; results first posted 2026-01-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Assess the Efficacy, Safety, and Tolerability of Vixarelimab in Reducing Pruritus in Prurigo Nodularis. Trials, record NCT03816891. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03816891
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Efficacy, Safety, and Tolerability of Vixarelimab in Reducing Pruritus in Prurigo Nodularis
- NCT number
- NCT03816891
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 240 participants, actual
- Lead sponsor
- Genentech, Inc.
- Conditions
- Prurigo Nodularis, Pruritis
- Interventions
- Vixarelimab, Placebo
- First posted
- 2019-01-25
- Last updated
- 2026-01-13
- Results first posted
- 2026-01-13
Source ClinicalTrials.gov
Registered outcomes39
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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) | Participants rated pruritus daily on the Worst Itch \[pruritis\] Numeric Rating Scale (WI-NRS: 0=no pruritus; 10=worst imaginable pruritus). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place. |
| 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 | Participants rated pruritus daily on the Worst Itch \[pruritis\]-Numeric Rating Scale (WI-NRS; 0=no pruritus; 10=worst imaginable pruritus). |
| Secondary | Phase 2a: Percent Change From Baseline in Pruritus Visual Analog Scale (VAS) at Week 8 | Baseline, Week 8 | At every visit, participants rated the intensity of their average pruritus over previous 3 days on VAS 0-10 line scale (0=no pruritis, 10=worst imaginable pruritis) |
| 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 | Participants rated pruritus daily on the Worst Itch \[pruritis\]-Numeric Rating Scale (WI-NRS; 0=no pruritus; 10=worst imaginable pruritus). |
| 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 | Participants rated pruritus daily on the Worst Itch \[pruritis\]-Numeric Rating Scale (WI-NRS; 0=no pruritus; 10=worst imaginable pruritus). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place. |
| 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 | Participants rated intensity of their average pruritus over previous 3 days on VAS 0-10 line scale (0=no pruritis, 10=worst imaginable pruritis) |
| 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 | Participants rated intensity of their average pruritus over previous 3 days on VAS 0-10 line scale (0=no pruritis, 10=worst imaginable pruritis). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place. |
| 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 | Administered every 2 visits, the 5-D Pruritus Scale evaluates pruritus in 5 domains: duration, degree, direction, disability and distribution. The scores from each domain are added together to obtain a total 5-D score ranging from 5 (no pruritus) to 25 (most severe pruritus). |
| 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 | Administered every 2 visits, the 5-D Pruritus Scale evaluates pruritus in five domains: duration, degree, direction, disability and distribution. The scores from each domain are added together to obtain a total 5-D score ranging from 5 (no pruritus) to 25 (most severe pruritus). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place. |
| 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 | Participants rated pruritus daily on the Worst Itch \[pruritis\]-Numeric Rating Scale (WI-NRS; 0=no pruritus; 10=worst imaginable pruritus). |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 registered outcomesOutcomes39
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 outcomesResults by group1,842
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 2a & 2b: Percent Change From Baseline in Weekly Average Worst Itch-Numeric Rating Scale (WI-NRS) Score | Phase 2a - Vixarelimab 360 mg SC QW | -50.6 | Standard Error 6.99 | percentage change | |
| Phase 2a & 2b: Percent Change From Baseline in Weekly Average Worst Itch-Numeric Rating Scale (WI-NRS) Score | Phase 2a - Placebo SC QW | -29.4 | Standard Error 6.80 | percentage change | |
| Phase 2a & 2b: Percent Change From Baseline in Weekly Average Worst Itch-Numeric Rating Scale (WI-NRS) Score | Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | -56.2 | Standard Error 4.84 | percentage change | |
| Phase 2a & 2b: Percent Change From Baseline in Weekly Average Worst Itch-Numeric Rating Scale (WI-NRS) Score | Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | -51.0 | Standard Error 4.83 | percentage change | |
| Phase 2a & 2b: Percent Change From Baseline in Weekly Average Worst Itch-Numeric Rating Scale (WI-NRS) Score | Phase 2b - Vixarelimab 120 mg SC, Q4W (DBL) | -33.0 | Standard Error 4.86 | percentage change | |
| Phase 2a & 2b: Percent Change From Baseline in Weekly Average Worst Itch-Numeric Rating Scale (WI-NRS) Score | Phase 2b - Placebo SC, Q4W (DBL), Then Vixarelimab (OLE) | -14.5 | Standard Error 4.76 | percentage change | |
| Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS at Week 8 | Phase 2a - Vixarelimab 360 mg SC QW | 52.2 | 95% Confidence Interval 30.6 to 73.2 | percentage of participants | |
| Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS at Week 8 | Phase 2a - Placebo SC QW | 30.8 | 95% Confidence Interval 14.3 to 51.8 | percentage of participants | |
| Phase 2a: Percent Change From Baseline in Pruritus Visual Analog Scale (VAS) at Week 8 | Phase 2a - Vixarelimab 360 mg SC QW | -54.4 | Standard Error 7.03 | percentage change | |
| Phase 2a: Percent Change From Baseline in Pruritus Visual Analog Scale (VAS) at Week 8 | Phase 2a - Placebo SC QW | -32.6 | Standard Error 6.96 | percentage change |
1 to 10 of 1,842Source ClinicalTrials.gov
See all 1,842 results by groupParticipant flow54
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Period | STARTED | Phase 2a - Vixarelimab 360 mg SC QW | 24 | |
| Double-Blind Period | STARTED | Phase 2a - Placebo SC QW | 26 | |
| Double-Blind Period | STARTED | Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | 47 | |
| Double-Blind Period | STARTED | Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | 47 | |
| Double-Blind Period | STARTED | Phase 2b - Vixarelimab 120 mg SC, Q4W (DBL) | 47 | |
| Double-Blind Period | STARTED | Phase 2b - Placebo SC, Q4W (DBL), Then Vixarelimab (OLE) | 49 | |
| Double-Blind Period | Randomized and Treated | Phase 2a - Vixarelimab 360 mg SC QW | 23 | |
| Double-Blind Period | Randomized and Treated | Phase 2a - Placebo SC QW | 26 | |
| Double-Blind Period | Randomized and Treated | Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | 47 | |
| Double-Blind Period | Randomized and Treated | Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | 47 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 participant flowAdverse events196
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | Phase 2a - Vixarelimab 360 mg SC QW | 0 | 23 | |
| other | Fatigue | General disorders | Phase 2a - Placebo SC QW | 0 | 26 | |
| other | Fatigue | General disorders | Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | 5 | 47 | |
| other | Fatigue | General disorders | Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | 1 | 47 | |
| other | Fatigue | General disorders | Phase 2b - Vixarelimab 120 mg SC, Q4W (DBL) | 1 | 47 | |
| other | Fatigue | General disorders | Phase 2b - Placebo SC, Q4W (DBL) | 1 | 48 | |
| other | Fatigue | General disorders | Phase 2b - Vixarelimab 360 mg SC, Q2W (OLE Period) | 3 | 181 | |
| other | COVID-19 | Infections and infestations | Phase 2a - Vixarelimab 360 mg SC QW | 0 | 23 | |
| other | COVID-19 | Infections and infestations | Phase 2a - Placebo SC QW | 0 | 26 | |
| other | COVID-19 | Infections and infestations | Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | 3 | 47 |
1 to 10 of 196Source ClinicalTrials.gov
See all 196 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 2a - Vixarelimab 360 mg SC QW | 0 | 23 |
| Total, all-cause mortality | Phase 2a - Placebo SC QW | 0 | 26 |
| Total, all-cause mortality | Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | 0 | 47 |
| Total, all-cause mortality | Phase 2b - Vixarelimab 360 mg SC, Q4W (DBL) | 0 | 47 |
| Total, all-cause mortality | Phase 2b - Vixarelimab 120 mg SC, Q4W (DBL) | 0 | 47 |
| Total, all-cause mortality | Phase 2b - Placebo SC, Q4W (DBL) | 0 | 48 |
| Total, all-cause mortality | Phase 2b - Vixarelimab 360 mg SC, Q2W (OLE Period) | 0 | 181 |
| Total, other adverse events | Phase 2a - Vixarelimab 360 mg SC QW | 17 | 23 |
| Total, other adverse events | Phase 2a - Placebo SC QW | 14 | 26 |
| Total, other adverse events | Phase 2b - Vixarelimab 540 mg SC Q4W (DBL) | 18 | 47 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
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