A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Incyte Corporation
Study ID
NCT05764161
Phase
PHASE3
Status
Completed

Conditions

  • Prurigo Nodularis

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib Cream — DRUG
    Ruxolitinib cream 1.5% twice daily (BID) during the continuous and open label treatment period.
  • Vehicle Cream — DRUG
    Ruxolitinib matching vehicle cream 1.5% twice daily (BID) during the vehicle-controlled period.

Study Details

The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN).

Key Dates

Start date
Jun 12, 2023
Status verified
Dec 2025
Primary completion
Dec 30, 2024
Completion
Nov 4, 2025

Study Design

Enrollment
190 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ruxolitinib 1.5% Cream
    Participants apply ruxolitinib 1.5% cream topically to the affected areas as a thin film BID for 12 weeks during the DBVC period. Participants who have completed the treatment during DBVC period will enter the open label extension (OLE) period for up to 40 weeks.
  • Placebo Comparator: Vehicle Cream
    Participants apply ruxolitinib matching vehicle cream topically to the affected areas as a thin film twice daily (BID) for 12 weeks during the DBVC period. Participants who have completed the treatment during DBVC period will enter the open label extension (OLE) period for up to 40 weeks.

Primary Outcome Measure

WI-NRS4 Response at Week 12 [ Time Frame: Baseline; Week 12 ]

Locations (16)

FacilityCityStateZIPSite coordinators
University of Alabama At BirminghamBirminghamAlabama35233-
Northwest Arkansas Clinical Trials CenterArkansas CityArkansas72758-
Dermatology Research AssociatesLos AngelesCalifornia90045-
Clinical Science Institute Clinical Research Specialists IncSanta MonicaCalifornia90404-
Cura Clinical ResearchSherman OaksCalifornia91403-
Ars - Maitland Clinical Research UnitOrlandoFlorida32819-
Marietta Dermatology the Skin Cancer Center MariettaMariettaGeorgia30060-1047-
The South Bend Clinic Main CampusSouth BendIndiana46617-
Axon Clinical ResearchBaltimoreMaryland21237-
Activmed Practices Research, Llc BeverlyBeverlyMassachusetts01915-
Oakview DermatologyAthensOhio45701-
Aventiv Research Inc-DublinDublinOhio43016-
Wright State Physicians, Inc.FairbornOhio45324-
University of Pittsburgh Medical Center Upmc Dermatology Clinic Oakland Falk Medical BuildingPittsburghPennsylvania15232-
Dermdox Center For DermatologySugarloafPennsylvania18249-
Dermresearch, Inc.AustinTexas78759-

Find similar trials in Birmingham, AL

By research site
University of Alabama At Birmingham· Birmingham, ALNorthwest Arkansas Clinical Trials Center· Arkansas City, ARDermatology Research Associates· Los Angeles, CAClinical Science Institute Clinical Research Specialists Inc· Santa Monica, CACura Clinical Research· Sherman Oaks, CAArs - Maitland Clinical Research Unit· Orlando, FL

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