CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 58 enrolled
Drug / intervention
KPL-716 +1 moredrug
Likely dose
KPL-716 720 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03858634
NCT03858634Phase 2Completed
CompareCT.gov

KPL-716-C202: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Pilot Study to Investigate the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Diseases Characterized by Chronic Pruritus

Genentech, Inc.·interventional·Posted Mar 1, 2019·Updated Mar 18, 2025

In Brief

A Phase 2 clinical trial evaluating KPL-716 and Placebo for Chronic Idiopathic Urticaria and 4 related conditions. Completed, enrolled 58 participants across 14 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Idiopathic Urticaria, Chronic Idiopathic Pruritus, Lichen Planus, Lichen Simplex Chronicus, Plaque Psoriasis
CountriesUnited States
CollaboratorsKiniksa Pharmaceuticals, Ltd.

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMar 1, 2019
Enrollment StartMay 29, 2019
Primary CompletionApr 1, 2020
Study CompletionJun 8, 2020
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 7.3 years ago

Interventions

KPL-716drug

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.

Placebodrug

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