Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS2)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Incyte Corporation
Study ID
NCT06958211
Phase
PHASE3
Status
Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Ruxolitinib Cream — DRUG
    Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
  • Vehicle Cream — DRUG
    Matching vehicle cream applied topically to the affected area as a thin film twice daily.

Study Details

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in participants with hidradenitis suppurativa.

Key Dates

Start date
Jun 12, 2025
Status verified
Apr 2026
Primary completion
Oct 9, 2026
Completion
Jul 11, 2027

Study Design

Enrollment
550 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ruxolitinib 1.5 % Cream
    Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol.
  • Placebo Comparator: Vehicle Cream
    Participants received vehicle cream, applied topically to the affected area as defined by the protocol.

Primary Outcome Measure

Proportion of participants who achieve Hidradenitis Suppurativa (HS) Clinical Response 75 (HiSCR75) from baseline [ Time Frame: Week 16 ]

Central Contacts

Locations (67)

FacilityCityStateZIPSite coordinators
Investigative Site US218BirminghamAlabama35244-
Investigative Site US257BirminghamAlabama35203-
Investigative Site US239MontgomeryAlabama36117-
Investigative Site US215PhoenixArizona85006-
Investigative Site US261PhoenixArizona85037-
Investigative Site US240TucsonArizona85718-
Investigative Site US262EncinoCalifornia91436-
Investigative Site US222Fountain ValleyCalifornia92708-
Investigative Site US211Los AngelesCalifornia90045-
Investigative Site US237Los AngelesCalifornia90056-
Investigative Site US234NorthridgeCalifornia91325-
Investigative Site US250Santa AnaCalifornia92706-
Investigative Site US244Castle RockColorado80109-
Investigative Site US252CromwellConnecticut06416-
Investigative Site US208Boca RatonFlorida33486-
Investigative Site US203HialeahFlorida33012-3618-
Investigative Site US258JacksonvilleFlorida32216-
Investigative Site US206MaitlandFlorida32751-
Investigative Site US202MiamiFlorida33173-
Investigative Site US223MiamiFlorida33136-
Investigative Site US241MiamiFlorida33147-
Investigative Site US214TampaFlorida33609-
Investigative Site US247TampaFlorida33612-
Investigative Site US231ColumbusGeorgia31904-
Investigative Site US225Sandy SpringsGeorgia30328-
Investigative Site US207SkokieIllinois60077-
Investigative Site US205PlainfieldIndiana46168-
Investigative Site US264Lake CharlesLouisiana70601-
Investigative Site US266New OrleansLouisiana70115-
Investigative Site US254GambrillsMaryland21054-
Investigative Site US201MarriottsvilleMaryland21104-
Investigative Site US253MilfordMassachusetts01757-
Investigative Site US227NeedhamMassachusetts02492-
Investigative Site US268WorcesterMassachusetts01605-
Investigative Site US238Ann ArborMichigan48103-
Investigative Site US230Auburn HillsMichigan48326-
Investigative Site US251St LouisMissouri63110-1010-
Investigative Site US271WildwoodMissouri63040-
Investigative Site US212MissoulaMontana59804-
Investigative Site US216Las VegasNevada89145-
Investigative Site US235HobokenNew Jersey07030-
Investigative Site US217AlbuquerqueNew Mexico87102-
Investigative Site US219BrooklynNew York11203-
Investigative Site US246ElmhurstNew York11373-
Investigative Site US269FairportNew York14450-
Investigative Site US213Kew GardensNew York11415-
Investigative Site US242New YorkNew York10075-
Investigative Site US245RochesterNew York14620-
Investigative Site US259HuntersvilleNorth Carolina28078-
Investigative Site US263Winston-SalemNorth Carolina27104-
Investigative Site US228ClevelandOhio44124-
Investigative Site US243ColumbusOhio43213-
Investigative Site US249ColumbusOhio43213-
Investigative Site US204PortlandOregon97201-
Investigative Site US226Plymouth MeetingPennsylvania19462-
Investigative Site US256BlufftonSouth Carolina29910-
Investigative Site US267Mt. PleasantSouth Carolina29464-
Investigative Site US255AustinTexas78759-
Investigative Site US260CypressTexas77429-
Investigative Site US270ProsperTexas75078-
Investigative Site US232Sugar LandTexas77479-
Investigative Site US248ArlingtonVirginia22206-
Investigative Site US209DanvilleVirginia24541-
Investigative Site US229NorfolkVirginia23502-
Investigative Site US265SeattleWashington98105-
Investigative Site US224SpokaneWashington99202-
Investigative Site US210MilwaukeeWisconsin53226-

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