Ignite Creation Date:
2025-12-24 @ 12:08 PM
Ignite Modification Date:
2025-12-27 @ 10:42 PM
Study NCT ID:
NCT05764161
Status:
COMPLETED
Last Update Posted:
2025-12-18
First Post:
2023-03-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)
Sponsor:
Incyte Corporation
Organization:
Study Overview
Official Title:
A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Prurigo Nodularis
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT05722912
Has Expanded Access, NCT# Status:
APPROVED_FOR_MARKETING
Acronym:
TRuE-PN2
Brief Summary:
The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN).
Detailed Description:
The study comprises of a 12 week double-blind, vehicle-controlled (DBVC) treatment period, followed by a 40 week open label extension period, and 30 day safety follow-up period During the double blind period, all PN-affected areas identified at baseline will be treated, and during the open label period, only active PN-affected areas will be treated.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2022-502461-23-00 | REGISTRY | EU CT Number | View |