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

Genentech

Status and phase: Completed; Phase 2

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

Treatments: Drug: KPL-716; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03858634

GX45045 (Other Identifier)

KPL-716-C202

Details and patient eligibility

About

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).

Enrollment: 58 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female aged 18 to 75 years
2. 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
3. Moderate to severe pruritus
4. 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
5. 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

1. Use of prohibited medications within the indicated timeframe from Day 1 to the End of Study
2. Is currently using medication known to cause pruritus
3. Has any inflammatory, pruritic, and/or fibrotic skin condition other than the diagnosis that defines inclusion
4. Laboratory abnormalities that fall outside the windows specified in the protocol at the Screening Visit
5. Has an active infection, including skin infection
6. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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58 participants in 2 patient groups, including a placebo group

KPL-716

Experimental group

Description:

Weekly for 8 weeks

Treatment:

Drug: KPL-716

Placebo

Placebo Comparator group

Description:

Weekly for 8 weeks

Treatment:

Drug: Placebo