Phase 2
N=58
A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases
Chronic Idiopathic Urticaria · Chronic Idiopathic Pruritus · Lichen Planus · Lichen Simplex Chronicus · Plaque Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT03858634 ↗Enrolled (actual)
58
Serious AEs
1.7%
Results posted
Dec 2021
Primary outcome: Primary: Change From Baseline in Weekly Average WI-NRS at Week 8 — -4.3; -1.1; -4.3; -3.7 score on a scale — p=0.3980
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- KPL-716 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Genentech, Inc.
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Weekly Average WI-NRS at Week 8 |
-4.3; -1.1; -4.3; -3.7; -3.1; -6.9 | 0.3980 |
| PRIMARY Percent Change From Baseline in Weekly Average WI-NRS at Week 8 |
-50.7; -19.0; -52.4; -48.8; -39.4; -85.0 | 0.4734 |
| SECONDARY Change From Baseline in Weekly Average WI-NRS Over Time |
-1.9; -0.9; -1.6; -1.4; -0.2; -3.0 | — |
| SECONDARY Percent Change From Baseline in Weekly Average WI-NRS Over Time |
-23.5; -16.2; -19.5; -18.3; -2.4; -44.2 | 0.6533 |
| SECONDARY Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time |
-1.7; 0.0; -1.3; -2.0; -0.4; -4.0 | — |
| SECONDARY Percent Change From Baseline in Pruritus VAS Over Time |
-23.6; -8.3; -15.3; -24.8; -5.3; -76.1 | 0.5763 |
| SECONDARY Change From Baseline in 5-D Pruritus Total Score Over Time |
-6.3; 0.0; -4.4; -4.0; -2.3; -6.8 | — |
| SECONDARY Percent Change From Baseline in 5-D Pruritus Total Score Over Time |
-31.3; 0.0; -24.2; -20.6; -11.8; -44.0 | 0.4995 |
| SECONDARY Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time |
0.0; 0.0; 21.4; 11.1; 0.0; 50.0 | — |
| SECONDARY Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only |
-0.7; 0.3; -0.9; -0.2; -1.0; -0.4 | — |
| SECONDARY Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only |
-26.6; -13.3; -36.4; -10.0; -40.8; -16.7 | — |
| SECONDARY Change From Baseline in Sleep Loss VAS Over Time |
-1.6; 0.1; 0.4; -2.1; -0.4; -2.8 | — |
| SECONDARY Percent Change From Baseline in Sleep Loss VAS Over Time |
-25.1; 2.9; 484.2; 108.2; -5.1; -45.5 | 0.5403 |
| SECONDARY Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time |
-2.1; -0.3; -0.6; -1.7; -0.3; -3.0 | — |
| SECONDARY Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time |
-35.3; -22.2; -4.9; -26.6; -3.6; -42.9 | 0.4979 |
| SECONDARY Change From Baseline in Weekly Average of Sleep Quality NRS Over Time |
-0.8; -0.3; -0.2; -1.6; -0.2; -2.6 | — |
| SECONDARY Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time |
-1.0; -28.7; -2.6; -26.3; -3.0; -40.7 | 0.6532 |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time |
-5.8; 0.0; -3.4; -8.0; -4.7; -4.5 | — |
| SECONDARY Percent Change From Baseline in DLQI Total Score Over Time |
-51.0; -3.7; -32.8; -52.4; -24.2; -53.5 | 0.2289 |
| SECONDARY Change From Baseline in ItchyQoL Total Score Over Time |
-17.0; 0.0; -10.9; -18.9; -27.3; -31.5 | — |
| SECONDARY Percent Change From Baseline in ItchyQoL Total Score Over Time |
-21.4; -0.2; -13.0; -24.3; -29.1; -47.8 | 0.5195 |
Summary
Participants with diseases characterized by chronic pruritus experiencing moderate to severe pruritus will be enrolled in this pilot Phase 2 study.
The diseases characterized by chronic pruritus investigated in this pilot study currently include chronic idiopathic urticaria (CIU), chronic idiopathic pruritus (CIP), lichen planus (LP), lichen simplex chronicus (LSC) and plaque psoriasis (PPs).
Eligibility Criteria
Inclusion Criteria
- Male or female aged 18 to 75 years
- Have clinical diagnosis of chronic idiopathic urticaria (CIU), chronic idiopathic pruritus (CIP), lichen planus (LP), lichen simplex chronicus (LSC) and plaque psoriasis (PPs) for at least 6 months
- Moderate to severe pruritus
- Female participants of childbearing potential must have a negative pregnancy test, be nonlactating, and have agreed to use a highly effective method of contraception, as specified in the protocol, from the Screening Visit until 10 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
- Use of prohibited medications within the indicated timeframe from Day 1 to the End of Study
- Is currently using medication known to cause pruritus
- Has any inflammatory, pruritic, and/or fibrotic skin condition other than the diagnosis that defines inclusion
- 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 participant 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 (NCT03858634). 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.