A Study to Evaluate the Mechanism of Action of Ruxolitinib Cream in Subjects With Vitiligo (TRuE-V MOA)

Part of paid clinical trials in Fountain Valley, California.

Sponsor
Incyte Corporation
Study ID
NCT04896385
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib cream — DRUG
    Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
  • Vehicle Cream — DRUG
    Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.

Study Details

The purpose of the study is to evaluate the Mechanism Of Action (MOA) of ruxolitinib cream in vitiligo by assessing the change in biomarkers.

Key Dates

Start date
Jun 23, 2021
Status verified
Aug 2025
Primary completion
Nov 17, 2022
Completion
Jul 10, 2023

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Ruxolitinib cream
    Ruxolitinib cream will be administered twice a day (BID) for 24 weeks
  • Placebo Comparator: Vehicle Cream
    Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.

Primary Outcome Measure

Percentage Change From Baseline in Chemokine (C-X-C Motif) Ligand 10 (CXCL10), an Immune Biomarker, at Week 4, Week 12, and Week 24 [ Time Frame: Baseline; Week 4, Week 12, and Week 24 ]

Locations (6)

FacilityCityStateZIPSite coordinators
First Oc DermatologyFountain ValleyCalifornia92708-
UC IrvineIrvineCalifornia92697-
George Washington Medical Faculty AssociatesWashington D.C.District of Columbia20037-
Suny Downstate Medical CenterBrooklynNew York11203-
Mount Sinai HospitalNew YorkNew York10029-
Dermatology Specialists of SpokaneSpokaneWashington99202-

Find similar trials in Fountain Valley, CA

By research site
First Oc Dermatology· Fountain Valley, CAUC Irvine· Irvine, CAGeorge Washington Medical Faculty Associates· Washington D.C., DCSuny Downstate Medical Center· Brooklyn, NYMount Sinai Hospital· New York, NYDermatology Specialists of Spokane· Spokane, WA

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