CompletedPhase 2

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

United States58 participantsStarted 2019-05-29

Plain-language 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).

Who can participate

Age range18 Years – 75 Years

SexALL

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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

What they're measuring

Change From Baseline in Weekly Average WI-NRS at Week 8

Timeframe: Baseline, Week 8

Percent Change From Baseline in Weekly Average WI-NRS at Week 8

Timeframe: Baseline, Week 8

Trial details

NCT IDNCT03858634

SponsorGenentech, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-04-01

Results submitted2021-10-14

View on ClinicalTrials.gov More Chronic Idiopathic Urticaria trials