INCB 18424-320: A phase 3, double-blind, randomised, vehicle-controlled, efficacy and safety study of ruxolitinib cream in participants with Prurigo Nodularis. Topical ruxolitinib evaluation in Prurigo Nodularis (TRuE-PN2)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502461-23-00

Acronym

INCB18424-320

Enrollment

117

Registered

2024-01-19

Start date

2024-02-15

Completion date

2025-11-04

Last updated

2025-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prurigo Nodularis

Brief summary

WI-NRS4 response at Week 12, defined as achieving a ≥ 4-point improvement (reduction) in WI-NRS score from baseline.

Detailed description

WI-NRS4 response at Week 4., Overall-TS at Week 12, defined as achieving both a WI-NRS4 response and an IGA-CPG-S TS. (IGA-CPG-S-TS is defined as an IGA-CPG-S score of 0 or 1 with a ≥ 2 grade improvement from baseline), IGA-CPG-S-TS at Week 12., WI-NRS4 response on Day 7.

Interventions

DRUGVehicle cream (same formulation of cream as the test product but without active substance)

DRUGRuxolitinib (INCB018424) cream

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
WI-NRS4 response at Week 4., Overall-TS at Week 12, defined as achieving both a WI-NRS4 response and an IGA-CPG-S TS. (IGA-CPG-S-TS is defined as an IGA-CPG-S score of 0 or 1 with a ≥ 2 grade improvement from baseline), IGA-CPG-S-TS at Week 12., WI-NRS4 response on Day 7.	—

Primary

Measure	Time frame
WI-NRS4 response at Week 12, defined as achieving a ≥ 4-point improvement (reduction) in WI-NRS score from baseline.	—

Countries

Austria, Bulgaria, Denmark, France, Germany, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026