INCB 18424-319: A phase 3, double-blind, randomised, vehicle-controlled, efficacy and safety study of ruxolitinib cream in participants with Purigo Nodularis. Topical ruxolitinib evaluation in Prurigo Nodularis (TRuE-PN1)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501621-20-00

Acronym

INCB18424-319

Enrollment

Registered

2023-08-18

Start date

2023-10-02

Completion date

2025-04-23

Last updated

2025-04-28

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 cream

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

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

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.	—

Countries

Belgium, France, Germany, Italy, Netherlands, Poland, Spain

Outcome results

None listed

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