Phase 2
N=240
Study to Assess the Efficacy, Safety, and Tolerability of Vixarelimab in Reducing Pruritus in Prurigo Nodularis
Prurigo Nodularis · Pruritis
Bottom Line
View on ClinicalTrials.gov: NCT03816891 ↗Enrolled (actual)
240
Serious AEs
3.6%
Results posted
Jan 2026
Primary outcome: Primary: Phase 2a & 2b: Percent Change From Baseline in Weekly Average Worst Itch-Numeric Rating Scale (WI-NRS) Score — -50.6; -29.4; -56.2; -51.0 percentage change — p=0.0347
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vixarelimab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Genentech, Inc.
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 2a & 2b: Percent Change From Baseline in Weekly Average Worst Itch-Numeric Rating Scale (WI-NRS) Score |
-50.6; -29.4; -56.2; -51.0; -33.0; -14.5 | 0.0347 sig |
| SECONDARY Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS at Week 8 |
52.2; 30.8 | 0.1093 |
| SECONDARY Phase 2a: Percent Change From Baseline in Pruritus Visual Analog Scale (VAS) at Week 8 |
-54.4; -32.6 | 0.0325 sig |
| SECONDARY Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time |
-1.6; -0.8; -2.4; -1.3; -2.9; -1.9 | — |
| SECONDARY Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time |
-20.2; -9.1; -27.3; -13.9; -33.6; -18.1 | 0.0657 |
| SECONDARY Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time |
-1.9; -1.4; -2.9; -1.8; -3.5; -2.2 | — |
| SECONDARY Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time |
-18.4; -15.8; -28.2; -18.3; -36.8; -19.2 | 0.7379 |
| SECONDARY Phase 2a: Change From Baseline in 5-D Pruritus Total Score Over Time |
-5.8; -2.7; -6.7; -3.9; -7.2; -4.2 | — |
| SECONDARY Phase 2a: Percent Change From Baseline in 5-D Pruritus Total Score Over Time |
-26.8; -13.3; -31.8; -21.7; -34.2; -23.6 | 0.0149 sig |
| SECONDARY Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time |
17.4; 7.7; 26.1; 7.7; 39.1; 11.5 | 0.2474 |
| SECONDARY Phase 2a: Change From Baseline in Sleep Loss VAS Over Time |
-2.0; -1.5; -2.8; -1.2; -3.3; -1.4 | — |
| SECONDARY Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time |
-22.0; -13.1; -25.5; -2.2; -25.1; 2.5 | 0.5172 |
| SECONDARY Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time |
-1.3; -0.9; -1.9; -1.7; -2.6; -2.1 | — |
| SECONDARY Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time |
-17.2; -13.5; -24.2; -22.5; -31.6; -25.8 | 0.5896 |
| SECONDARY Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time |
-1.4; -0.8; -1.9; -1.5; -2.6; -1.7 | — |
| SECONDARY Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time |
-11.0; -12.0; -21.9; -20.6; -29.6; -20.9 | 0.8948 |
| SECONDARY Phase 2a: Change From Baseline in Quality of Life (QoL) Measure Dermatology QoL Index (DLQI) Over Time |
-6.7; -2.8; -8.3; -4.5; -8.9; -6.1 | — |
| SECONDARY Phase 2a: Percent Change From Baseline in QoL Measure DLQI Over Time |
-40.0; -12.0; -50.4; -29.1; -54.1; -41.7 | 0.0018 sig |
| SECONDARY Phase 2a: Change From Baseline in QoL Measure Itchy Quality of Life (ItchyQoL) Over Time |
-16.3; -6.2; -25.3; -11.0; -27.6; -14.5 | — |
| SECONDARY Phase 2a: Percent Change From Baseline in QoL Measure Itchy QoL Over Time |
-16.4; -6.6; -27.5; -14.1; -29.6; -17.7 | 0.0079 sig |
| SECONDARY Phase 2a: Change From Baseline in Prurigo Nodularis Nodule Assessment Tool (PN-NAT) Over Time: Number of Nodules Over the Whole Body Score |
-0.2; -0.1; -0.4; -0.2; -0.5; -0.2 | — |
| SECONDARY Phase 2a: Change From Baseline in PN-NAT Over Time: Estimate of Hardness of Nodules Over the Whole Body |
-0.2; -0.2; -0.5; -0.4; -0.6; -0.5 | — |
| SECONDARY Phase 2a: Change From Baseline in PN-NAT Over Time: Extent of Excoriations Over the Whole Body |
-0.2; -0.2; -0.5; -0.7; -0.6; -0.7 | — |
| SECONDARY Phase 2a: Percentage of Participants With Improvement in Prurigo Nodularis Investigator Global Assessment (PN-IGA) by 2 Categories Over Time |
8.7; 7.7; 13.0; 7.7; 43.5; 11.5 | 0.8436 |
| SECONDARY Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS at Week 16 |
42.6; 23.4; 17.4; 2.1 | <0.0001 sig |
| SECONDARY Phase 2b: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS at Week 16 |
66.0; 61.7; 29.8; 16.7 | <0.0001 sig |
| SECONDARY Phase 2b: Percentage of Participants Achieving a Score of 0 or 1 in PN-IGA at Week 16 |
38.3; 29.8; 14.9; 10.4 | 0.0017 sig |
| SECONDARY Phase 2b: Change From Baseline in Weekly Average of WI-NRS Over Time |
-1.7; -1.1; -0.9; -0.4; -2.8; -1.9 | <0.0001 sig |
| SECONDARY Phase 2b: Percent Change From Baseline in Weekly Average of WI-NRS Over Time |
-19.6; -12.5; -10.0; -5.1; -33.2; -21.9 | <0.0001 sig |
| SECONDARY Phase 2b: Percentage of Participants Achieving at Least a 6-Point Reduction From Baseline in Weekly Average WI-NRS Over Time |
4.3; 0; 2.2; 2.1; 12.8; 4.3 | 0.5673 |
| SECONDARY Phase 2b: Percentage of Participants Achieving at Least a 4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time |
10.6; 4.3; 4.3; 2.1; 25.5; 17.0 | 0.0957 |
| SECONDARY Phase 2b: Percentage of Participants Achieving 0 or 1 in PN-IGA Over Time |
6.4; 0.0; 2.1; 0; 6.4; 4.3 | 0.0841 |
| SECONDARY Phase 2b: Percentage of Participants With at Least 2-Point Improvement From Baseline in PN-IGA Over Time |
6.4; 2; 6.4; 2.1; 14.9; 10.6 | 0.3137 |
| SECONDARY Phase 2b: Percentage of Participants Achieving 0 (Clear) or 1 (Almost Clear) in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) Over Time |
4.3; 2.1; 2.1; 0; 8.5; 4.3 | 0.1656 |
| SECONDARY Phase 2b: Percentage of Participants With at Least 2-point Improvement From Baseline in IGA-CNPG-S Over Time |
4.3; 6.4; 4.3; 2.1; 12.8; 10.6 | 0.5673 |
| SECONDARY Phase 2b: Change From Baseline in Weekly Average of Sleep Loss VAS Over Time |
-2.9; -2.4; -1.5; -0.1; -3.1; -2.1 | <0.0001 sig |
| SECONDARY Phase 2b: Percent Change From Baseline in Weekly Average of Sleep Loss VAS Over Time |
-63.6; -24.9; -28.5; 81.4; -50.6; -30.2 | 0.0001 sig |
| SECONDARY Phase 2b: Change From Baseline in ItchyQoL Over Time |
-19.7; -13.4; -11.5; -1.7; -26.1; -17.4 | <0.0001 sig |
| SECONDARY Phase 2b: Percent Change From Baseline in ItchyQoL Over Time |
-25.4; -17.2; -13.8; -0.6; -32.8; -21.8 | <0.0001 sig |
Summary
Study of the efficacy, safety, tolerability, pharmacokinetics (PK), and immunogenicity of Vixarelimab (KPL-716) in subjects with prurigo nodularis (PN).
Eligibility Criteria
Inclusion Criteria (apply to both Phase 2a and Phase 2b unless otherwise specified):
- Male or female aged 18 to 75 years (Phase 2a), 18 to 80 years (Phase 2b)
- Have clinical diagnosis of prurigo nodularis for at least 6 months
- Have at least 10 nodules (Phase 2a), 20 nodules (Phase 2b) at the Screening Visit and Day 1
- Moderate to severe pruritus (Phase 2a); severe pruritus (Phase 2b)
- Female subjects of childbearing potential must have a negative pregnancy test, be nonlactating, and having agreed to use a highly effective method of contraception, as specified in the protocol, from the Screening Visit until 16 weeks after final study drug administration
- Able to comprehend and willing to sign an Informed Consent Form and able to abide by the study restrictions and comply with all study procedures for the duration of the study
Exclusion Criteria (apply to both Phase 2a and Phase 2b unless otherwise specified):
- Use of prohibited medications within the indicated timeframe from Day 1
- Is currently using medication known to cause pruritus
- Presence of any inflammatory, pruritic, and/or fibrotic skin condition other than moderate to severe prurigo nodularis or atopic dermatitis unless approved by the Sponsor
- Laboratory abnormalities that fall outside the windows specified in the protocol at the Screening Visit
- Has an active infection, including skin infection
- Any medical or psychiatric condition which, in the opinion of the Investigator or the Sponsor, may place the subject at increased risk as a result of study participation, interfere with study participation or study assessments, affect compliance with study requirements, or complicate interpretation of study results
Data sourced from ClinicalTrials.gov (NCT03816891). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.