Study to Evaluate of the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Incyte Corporation
Study ID
NCT05635838
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 this study is to evaluate the efficacy and safety of Ruxolitinib cream in participants with Hidradenitis Suppurativa. This is a randomized 16-week double-blind, vehicle-controlled (DBVC) study followed by a 16 week open label extension period (OLE) with an active treatment for participants who complete the DBVC period.

Key Dates

Start date
Dec 7, 2022
Status verified
Oct 2024
Primary completion
Oct 19, 2023
Completion
Mar 14, 2024

Study Design

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

Arms

  • Experimental: Ruxolitinib Cream
    Ruxolitinib 1.5% cream BID for 16 weeks of double-blind, vehicle-controlled (DBVC) period followed by ruxolitinb 1.5% cream BID for 16 weeks in an open-label extension.
  • Experimental: Vehicle Cream
    Vehicle cream BID for 16 weeks of double-blind, vehicle-controlled (DBVC) period followed by ruxolitinb 1.5% cream BID for 16 weeks in an open-label extension.

Primary Outcome Measure

Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16 [ Time Frame: Baseline; Week 16 ]

Locations (15)

FacilityCityStateZIPSite coordinators
Medical Dermatology Specialists PhoenixPhoenixArizona85006-
First Oc DermatologyFountain ValleyCalifornia92708-
Skin Care Research, Llc Scr HollywoodBoca RatonFlorida33486-
Forcare Clinical ResearchTampaFlorida33613-
Marietta Dermatology the Skin Cancer Center MariettaMariettaGeorgia30060-1047-
Delricht ResearchBaton RougeLouisiana70809-
Delricht ResearchNew OrleansLouisiana70115-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Revival Research Institute, Llc TroyTroyMichigan48084-
Dr Bobby Buka, Md Greenwich VillageNew YorkNew York10012-1354-
Dermatology Associates of Plymouth MeetingPlymouth MeetingPennsylvania19462-
International Clinical Research Tennessee LlcMurfreesboroTennessee37130-
Austin Institute For Clinical Research Aicr PflugervillePflugervilleTexas78660-
Progressive Clinical ResearchSan AntonioTexas78213-
Dermatology Specialists of SpokaneSpokaneWashington99202-

Find similar trials in Phoenix, AZ

By condition
Hidradenitis suppurativa
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Medical Dermatology Specialists Phoenix· Phoenix, AZFirst Oc Dermatology· Fountain Valley, CASkin Care Research, Llc Scr Hollywood· Boca Raton, FLForcare Clinical Research· Tampa, FLMarietta Dermatology the Skin Cancer Center Marietta· Marietta, GADelricht Research· Baton Rouge, LA

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