Trial · NCT03858634
A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases
NCT03858634, Phase 2, Completed, Genentech, Inc.; results first posted 2021-12-28
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases. Trials, record NCT03858634. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03858634
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases
- NCT number
- NCT03858634
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 58 participants, actual
- Lead sponsor
- Genentech, Inc.
- Conditions
- Chronic Idiopathic Urticaria, Chronic Idiopathic Pruritus, Lichen Planus, Lichen Simplex Chronicus, Plaque Psoriasis
- Interventions
- KPL-716, Placebo
- First posted
- 2019-03-01
- Last updated
- 2025-03-18
- Results first posted
- 2021-12-28
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Weekly Average WI-NRS at Week 8 | Baseline, Week 8 | WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement. |
| Primary | Percent Change From Baseline in Weekly Average WI-NRS at Week 8 | Baseline, Week 8 | WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement. |
| Secondary | Change From Baseline in Weekly Average WI-NRS Over Time | Baseline, Weeks 1-18 | WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement. |
| Secondary | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Baseline, Weeks 1-18 | WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement. |
| Secondary | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Baseline, Weeks 1-8, 10, 12, 14, 16, 18 | Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average pruritus experienced over the previous 3 days using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. |
| Secondary | Percent Change From Baseline in Pruritus VAS Over Time | Baseline, Weeks 1-8, 10, 12, 14, 16, 18 | Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average pruritus experienced over the previous 3 days using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. |
| Secondary | Change From Baseline in 5-D Pruritus Total Score Over Time | Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18 | This tool evaluates pruritus in 5 domains: duration, degree, direction, disability and distribution. Duration, degree and direction each consist of 1 item. The disability domain contains 4 items and the distribution domain includes 16 items. The first 4 domains are measured on a 5-point Likert scale. The scores from each domain are added together to obtain a total 5-D score ranging from 5 (no pruritus) and 25 (most severe pruritus). |
| Secondary | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18 | This tool evaluates pruritus in 5 domains: duration, degree, direction, disability and distribution. Duration, degree and direction each consist of 1 item. The disability domain contains 4 items and the distribution domain includes 16 items. The first 4 domains are measured on a 5-point Likert scale. The scores from each domain are added together to obtain a total 5-D score ranging from 5 (no pruritus) and 25 (most severe pruritus). |
| Secondary | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Baseline, Weeks 1-18 | WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement. |
| Secondary | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Baseline, Weeks 1-18 | Participants were asked daily to self-assess the intensity of their pruritus on a Weekly Average Itch Severity Score, which is a Component of Urticaria Activity Score 7 (UAS7). The score for pruritis was graded from 0 (none) to 3 (intense), which was averaged over 7 consecutive days. The greater the severity of the disease the higher the score. Per protocol, the UAS7 tool was completed only by participants in the CIU Cohort. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Weekly Average WI-NRS at Week 8 | Baseline, Week 8 | Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Weekly Average WI-NRS Over Time | Baseline, Weeks 1-18 | Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed. | score on a scale | MEAN |
| SECONDARY | Percent Change From Baseline in Weekly Average WI-NRS Over Time | Baseline, Weeks 1-18 | Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time | Baseline, Weeks 1-8, 10, 12, 14, 16, 18 | Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed. | units on a scale | MEAN |
| SECONDARY | Percent Change From Baseline in Pruritus VAS Over Time | Baseline, Weeks 1-8, 10, 12, 14, 16, 18 | Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 5-D Pruritus Total Score Over Time | Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18 | Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed. | units on a scale | MEAN |
| SECONDARY | Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18 | Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time | Baseline, Weeks 1-18 | Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Baseline, Weeks 1-18 | Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed. | score on a scale | MEAN |
| SECONDARY | Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only | Baseline, Weeks 1-18 | Modified intent to treat (mITT) set: all randomized participants who received at least 1 dose of KPL-716 or placebo and had at least 1 post-baseline efficacy assessment in the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF) method. Once a participant started treatment period (through Week 8), missing data in treatment period were imputed. Once a participant started the follow up (FU) period, missing data in FU period were imputed. | percent change | MEAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group2,034
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Weekly Average WI-NRS at Week 8 | KPL-716: CIU Cohort | -4.3 | Standard Error 1.84 | score on a scale | |
| Change From Baseline in Weekly Average WI-NRS at Week 8 | Placebo: CIU Cohort | -1.1 | Standard Error 2.66 | score on a scale | |
| Change From Baseline in Weekly Average WI-NRS at Week 8 | KPL-716: CIP Cohort | -4.3 | Standard Error 0.77 | score on a scale | |
| Change From Baseline in Weekly Average WI-NRS at Week 8 | Placebo: CIP Cohort | -3.7 | Standard Error 0.96 | score on a scale | |
| Change From Baseline in Weekly Average WI-NRS at Week 8 | KPL-716: LP Cohort | -3.1 | Standard Error 0.82 | score on a scale | |
| Change From Baseline in Weekly Average WI-NRS at Week 8 | KPL-716: LSC Cohort | -6.9 | Standard Error 0.81 | score on a scale | |
| Change From Baseline in Weekly Average WI-NRS at Week 8 | Placebo: LSC Cohort | 0.7 | Standard Error 1.84 | score on a scale | |
| Change From Baseline in Weekly Average WI-NRS at Week 8 | KPL-716: PPs Cohort | -5.6 | Standard Error 0.69 | score on a scale | |
| Change From Baseline in Weekly Average WI-NRS at Week 8 | Placebo: PPs Cohort | -2.5 | Standard Error 0.98 | score on a scale | |
| Change From Baseline in Weekly Average WI-NRS Over Time | KPL-716: CIU Cohort | Change at Week 1 | -1.9 | Standard Error 0.59 | score on a scale |
1 to 10 of 2,034Source ClinicalTrials.gov
See all 2,034 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | KPL-716 | 39 | |
| Overall Study | STARTED | Placebo | 19 | |
| Overall Study | Participants With Chronic Idiopathic Urticaria (CIU) | KPL-716 | 4 | |
| Overall Study | Participants With Chronic Idiopathic Urticaria (CIU) | Placebo | 2 | |
| Overall Study | Participants With Chronic Idiopathic Pruritus (CIP) | KPL-716 | 14 | |
| Overall Study | Participants With Chronic Idiopathic Pruritus (CIP) | Placebo | 9 | |
| Overall Study | Participants With Lichen Planus (LP) | KPL-716 | 3 | |
| Overall Study | Participants With Lichen Planus (LP) | Placebo | 0 | |
| Overall Study | Participants With Lichen Simplex Chronicus (LSC) | KPL-716 | 4 | |
| Overall Study | Participants With Lichen Simplex Chronicus (LSC) | Placebo | 1 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events90
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 | Upper respiratory tract infection | Infections and infestations | KPL-716 | 2 | 39 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 1 | 19 | |
| other | Influenza | Infections and infestations | KPL-716 | 1 | 39 | |
| other | Influenza | Infections and infestations | Placebo | 1 | 19 | |
| other | Sinusitis | Infections and infestations | KPL-716 | 1 | 39 | |
| other | Sinusitis | Infections and infestations | Placebo | 1 | 19 | |
| other | Urinary tract infection | Infections and infestations | KPL-716 | 1 | 39 | |
| other | Urinary tract infection | Infections and infestations | Placebo | 1 | 19 | |
| other | Conjunctivitis | Infections and infestations | KPL-716 | 1 | 39 | |
| other | Conjunctivitis | Infections and infestations | Placebo | 0 | 19 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | KPL-716 | 0 | 39 |
| Total, all-cause mortality | Placebo | 0 | 19 |
| Total, other adverse events | KPL-716 | 15 | 39 |
| Total, other adverse events | Placebo | 11 | 19 |
| Total, serious adverse events | KPL-716 | 1 | 39 |
| Total, serious adverse events | Placebo | 0 | 19 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| KPL-716 vs Placebo: deaths from any cause | Trial comparisons |
| KPL-716 vs Placebo: serious adverse events | Trial comparisons |
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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03858634
GET https://conductscience.org/api/trials/v1/NCT03858634/registered?page=2