A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases

NCT03858634 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: KPL-716-C202GX45045
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 14

Brief 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).

Conditions

Chronic Idiopathic Urticaria; Chronic Idiopathic Pruritus; Lichen Planus; Lichen Simplex Chronicus; Plaque Psoriasis

Keywords

pruritus, chronic pruritus, moderate to severe

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Weekly Average WI-NRS at 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.

  Baseline, Week 8

• Percent Change From Baseline in Weekly Average WI-NRS at 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.

  Baseline, Week 8

Secondary Outcomes (19)

• Change From Baseline in Weekly Average WI-NRS Over Time

  Baseline, Weeks 1-18

• Percent Change From Baseline in Weekly Average WI-NRS Over Time

  Baseline, Weeks 1-18

• Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time

  Baseline, Weeks 1-8, 10, 12, 14, 16, 18

• Percent Change From Baseline in Pruritus VAS Over Time

  Baseline, Weeks 1-8, 10, 12, 14, 16, 18

• Change From Baseline in 5-D Pruritus Total Score Over Time

  Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18

Study Arms (2)

KPL-716

EXPERIMENTAL

Weekly for 8 weeks

Drug: KPL-716

Placebo

PLACEBO COMPARATOR

Weekly for 8 weeks

Drug: Placebo

Interventions

KPL-716 DRUG

A loading dose of KPL-716 720 mg (2x maintenance dose) administered via 2 subcutaneous (SC) injections within 30 minutes on Day 1. All subsequent doses of KPL-716 (360 mg maintenance dose) administered via a single SC injection.

Also known as: Vixarelimab, RG6536

KPL-716

Placebo DRUG

Placebo dose administered via 2 SC injections within 30 minutes on Day 1. All subsequent doses of placebo administered via a single SC injection.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Use of prohibited medications within the indicated timeframe from Day 1 to the End of Study
• Is currently using medication known to cause pruritus
• 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

Sponsors & Collaborators

• Genentech, Inc.: lead
• Kiniksa Pharmaceuticals, Ltd.: collaborator

Study Sites (14)

Site 106

Anniston, Alabama, 36207, United States

Location

Site 110

Phoenix, Arizona, 85032, United States

Location

Site 114

Hot Springs, Arkansas, 71913, United States

Location

Site 103

Los Angeles, California, 90045, United States

Location

Site 113

Sweetwater, Florida, 33172, United States

Location

Site 105

Normal, Illinois, 61761, United States

Location

Site 112

Plainfield, Indiana, 46168, United States

Location

Site 119

New Orleans, Louisiana, 70115, United States

Location

Site 109

Fort Gratiot, Michigan, 48059, United States

Location

Site 123

New York, New York, 10012, United States

Location

Site 115

Johnston, Rhode Island, 02919, United States

Location

Site 104

Pflugerville, Texas, 78660, United States

Location

Site 101

San Antonio, Texas, 78213, United States

Location

Site 122

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Chronic Urticaria; Lichen Planus; Neurodermatitis; Pruritus

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Dermatitis; Skin Diseases, Eczematous; Skin Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Medical Communications
• Organization: Genentech, Inc.

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 1, 2019
• Study Start: May 29, 2019
• Primary Completion: April 1, 2020
• Study Completion: June 8, 2020
• Last Updated: March 18, 2025
• Results First Posted: December 28, 2021

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)