Clinical trial NCT06959225: Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS1)
Official title: A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hidradenitis Suppurativa
Keywords: Hidradenitis suppurativa
skin disease
ruxolitinb cream
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2025-05-06
Enrollment: 400
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* Diagnosis of HS for at least 6 months prior to screening visit.
* Mild to moderate HS (Hurley I or II) with the following at both screening and baseline visits:

  * A total AN count of at least 4, with no draining tunnels AND
  * Affecting at least 2 distinct anatomical areas
* Agreement to NOT use topical and systemic antibiotics for treatment of HS during the vehicle-controlled period.
* Agreement to NOT use topical antiseptics, including washes and leave-on products on the areas affected by HS lesions during the vehicle-controlled period and Weeks 16 to 20 of the extension period.
* Further inclusion criteria apply.

Exclusion Criteria:

* Body surface areas to be treated exceed 20% BSA at screening or baseline
* Presence of draining tunnels at screening or baseline.
* Medical history including current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.
* Laboratory values outside of the protocol-defined criteria.
* Pregnant or lactating participants, or those considering pregnancy during the period of their study participation.
* Further exclusion criteria apply.

Primary outcomes:
measure: Proportion of participants who achieve Hidradenitis Suppurativa (HS) Clinical Response 75 (HiSCR75) from baseline
timeFrame: Week 16
Secondary outcomes:
measure: Proportion of participants with ≥ 1 flare
timeFrame: Up to 16 weeks
measure: Proportion of participants who achieve Skin Pain Numeric Rating Scale (NRS)30 among participants with baseline Skin Pain NRS score ≥ 3
timeFrame: Week 16
measure: Treatment-IR Population: Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) from baseline
timeFrame: Week 16
measure: Treatment-IR Population: Proportion of participants with ≥ 1 HS flare
timeFrame: Up to 16 weeks
measure: Treatment-IR Population: Proportion of participants who achieve Skin Pain Numeric Rating Scale (NRS)30 at Week 12 among participants with baseline Skin Pain NRS score ≥ 3
timeFrame: Week 16
measure: Proportion of participants who achieve HiSCR50/75/90/100 at each postbaseline visit
timeFrame: Up to 16 weeks
measure: Extension Period: Proportion of participants with ≥ 1 HS flare
timeFrame: From Week 16 through Week 52
measure: Proportion of participants who achieve abscess and/or inflammatory nodule (AN)75 at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Mean change from baseline in total AN count at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Percentage change from baseline in total AN count at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Mean change from baseline in abscess count at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Percentage change from baseline in abscess count at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Mean change from baseline in inflammatory nodule count at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Percentage change from baseline in inflammatory nodule count at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Proportion of participants with presence of draining tunnels at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Proportion of participants who achieve Skin Pain Numeric Rating Scale (NRS)30 among participants with baseline Skin Pain NRS score ≥ 3 at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Proportion of participants who achieve Itch Numeric Rating Scale (NRS)30 among participants with baseline Itch NRS score ≥ 3 at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Proportion of participants who achieve Patient Global Impression of Change (PGIC) at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Proportion of participants who achieve PGIC score 1 or 2 at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Patient Global Impression of Severity (PGIS) score at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Change from baseline in PGIS Score at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Proportion of participants who achieve status of Dermatology Life Quality Index (DLQ1)4 at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Proportion of participants who achieve status of Children's Dermatology Life Quality Index (CDLQ1)6 at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Change from baseline in Hidradenitis Suppurativa Quality of Life (HiSQoL) score at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Percent change from baseline in Hidradenitis Suppurativa Quality of Life (HiSQoL) score at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Change from baseline in Hidradenitis Suppurativa Quality of Life - Adolescent (HiSQoL-AA) at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Percent change from baseline in Hidradenitis Suppurativa Quality of Life - Adolescent (HiSQoL-AA) at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Change from baseline in EuroQol 5-dimension 5-level scale (EQ-5D-5L) score at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Treatment-IR Population: Change from baseline in total abscess count at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Treatment-IR Population: Percent change from baseline in total abscess count at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Treatment-IR Population: Change from baseline in total inflammatory nodule count at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Treatment-IR Population: Percent change from baseline in total inflammatory nodule count at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Treatment-IR Population: Proportion of participants with presence of draining tunnels at each postbaseline visit
timeFrame: Up to 52 weeks
measure: Number of Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to 56 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Investigative Site US020
state: Arizona
city: Scottsdale
country: United States
facility: Investigative Site US033
state: Arizona
city: Tempe
country: United States
facility: Investigative Site US054
state: Arizona
city: Fayetteville
country: United States
facility: Investigative Site US002
state: Arkansas
city: Chino
country: United States
facility: Investigative Site US055
state: California
city: Laguna Niguel
country: United States
facility: Investigative Site US004
state: California
city: Los Angeles
country: United States
facility: Investigative Site US007
state: California
city: San Diego
country: United States
facility: Investigative Site US013
state: California
city: San Diego
country: United States
facility: Investigative Site US060
state: California
city: San Diego
country: United States
facility: Investigative Site US038
state: California
city: Aurora
country: United States
facility: Investigative Site US059
state: Colorado
city: Wilmington
country: United States
facility: Investigative Site US056
state: Delaware
city: Boynton Beach
country: United States
facility: Investigative Site US045
state: Florida
city: Brandon
country: United States
facility: Investigative Site US029
state: Florida
city: Fort Myers
country: United States
facility: Investigative Site US028
state: Florida
city: Miami
country: United States
facility: Investigative Site US016
state: Florida
city: Sanford
country: United States
facility: Investigative Site US027
state: Florida
city: Sweetwater
country: United States
facility: Investigative Site US057
state: Florida
city: Atlanta
country: United States
facility: Investigative Site US061
state: Georgia
city: Atlanta
country: United States
facility: Investigative Site US053
state: Georgia
city: Marietta
country: United States
facility: Investigative Site US019
state: Georgia
city: Chicago
country: United States
facility: Investigative Site US026
state: Illinois
city: Libertyville
country: United States
facility: Investigative Site US042
state: Illinois
city: Clarksville
country: United States
facility: Investigative Site US049
state: Indiana
city: West Lafayette
country: United States
facility: Investigative Site US052
state: Indiana
city: Bowling Green
country: United States
facility: Investigative Site US001
state: Kentucky
city: Louisville
country: United States
facility: Investigative Site US022
state: Kentucky
city: Baton Rouge
country: United States
facility: Investigative Site US050
state: Louisiana
city: Glenn Dale
country: United States
facility: Investigative Site US046
state: Maryland
city: Boston
country: United States
facility: Investigative Site US003
state: Massachusetts
city: Quincy
country: United States
facility: Investigative Site US010
state: Massachusetts
city: Dearborn
country: United States
facility: Investigative Site US051
state: Michigan
city: Minneapolis
country: United States
facility: Investigative Site US006
state: Minnesota
city: Saint Paul
country: United States
facility: Investigative Site US021
state: Minnesota
city: Saint Joseph
country: United States
facility: Investigative Site US036
state: Missouri
city: New City
country: United States
facility: Investigative Site US034
state: New York
city: New York
country: United States
facility: Investigative Site US018
state: New York
city: New York
country: United States
facility: Investigative Site US017
state: New York
city: Rochester
country: United States
facility: Investigative Site US023
state: New York
city: Chapel Hill
country: United States
facility: Investigative Site US014
state: North Carolina
city: Fargo
country: United States
facility: Investigative Site US025
state: North Dakota
city: Bexley
country: United States
facility: Investigative Site US015
state: Ohio
city: Cincinnati
country: United States
facility: Investigative Site US044
state: Ohio
city: Columbus
country: United States
facility: Investigative Site US008
state: Ohio
city: Mason
country: United States
facility: Investigative Site US031
state: Ohio
city: Oklahoma City
country: United States
facility: Investigative Site US048
state: Oklahoma
city: Danville
country: United States
facility: Investigative Site US043
state: Pennsylvania
city: Charleston
country: United States
facility: Investigative Site US024
state: South Carolina
city: Myrtle Beach
country: United States
facility: Investigative Site US041
state: South Carolina
city: Murfreesboro
country: United States
facility: Investigative Site US005
state: Tennessee
city: Nashville
country: United States
facility: Investigative Site US047
state: Tennessee
city: Dallas
country: United States
facility: Investigative Site US032
state: Texas
city: Dallas
country: United States
facility: Investigative Site US062
state: Texas
city: El Paso
country: United States
facility: Investigative Site US035
state: Texas
city: Plano
country: United States
facility: Investigative Site US012
state: Texas
city: San Antonio
country: United States
facility: Investigative Site US011
state: Texas
city: Layton
country: United States
facility: Investigative Site US040
state: Utah
city: Ogden
country: United States
facility: Investigative Site US039
state: Utah
city: Salt Lake City
country: United States
facility: Investigative Site US037
state: Utah
city: Seattle
country: United States
facility: Investigative Site US058
state: Washington
city: Sofia
country: Bulgaria
facility: Investigative Site BG002
city: Sofia
country: Bulgaria
facility: Investigative Site BG003
city: Stara Zagora
country: Bulgaria
facility: Investigative Site BG001
city: Calgary
country: Canada
facility: Investigative Site CA004
state: Alberta
city: Calgary
country: Canada
facility: Investigative Site CA003
state: Alberta
city: Ottawa
country: Canada
facility: Investigative Site CA009
state: Ontario
city: Peterborough
country: Canada
facility: Investigative Site CA002
state: Ontario
city: Richmond Hill
country: Canada
facility: Investigative Site CA001
state: Ontario
city: Toronto
country: Canada
facility: Investigative Site CA007
state: Ontario
city: Toronto
country: Canada
facility: Investigative Site CA005
state: Ontario
city: Waterloo
country: Canada
facility: Investigative Site CA006
state: Ontario
city: Sherbrooke
country: Canada
facility: Investigative Site CA008
state: Quebec
city: Bordeaux
country: France
facility: Investigative Site FR002
city: Brest Cedex 2
country: France
facility: Investigative Site FR005
city: Cedex 10
country: France
facility: Investigative Site FR001
city: Nantes Cedex 1
country: France
facility: Investigative Site FR004
city: Nice Cedex 3
country: France
facility: Investigative Site FR003
city: Berlin
country: Germany
facility: Investigative Site DE006
city: Berlin
country: Germany
facility: Investigative Site DE005
city: Bochum
country: Germany
facility: Investigative Site DE002
city: Darmstadt
country: Germany
facility: Investigative Site DE004
city: Dresden
country: Germany
facility: Investigative Site DE001
city: Erlangen
country: Germany
facility: Investigative Site DE003
city: Hamburg
country: Germany
facility: Investigative Site DE007
city: Lubeck
country: Germany
facility: Investigative Site DE008
city: Catania
country: Italy
facility: Investigative Site IT001
city: Cona
country: Italy
facility: Investigative Site IT005
city: Firenze
country: Italy
facility: Investigative Site IT009
city: Milan
country: Italy
facility: Investigative Site IT002
city: Napoli
country: Italy
facility: Investigative Site IT007
city: Roma
country: Italy
facility: Investigative Site IT006
city: Roma
country: Italy
facility: Investigative Site IT004
city: Rozzano
country: Italy
facility: Investigative Site IT003
city: Torino
country: Italy
facility: Investigative Site IT008
city: Lodz
country: Poland
facility: Investigative Site PL002
city: Torun
country: Poland
facility: Investigative Site PL003
city: Warszawa
country: Poland
facility: Investigative Site PL001
city: Wroclaw
country: Poland
facility: Investigative Site PL004
city: Alicante
country: Spain
facility: Investigative Site ES004
city: Badalona
country: Spain
facility: Investigative Site ES005
city: Barcelona
country: Spain
facility: Investigative Site ES003
city: Madrid
country: Spain
facility: Investigative Site ES001
city: Madrid
country: Spain
facility: Investigative Site ES002
city: Bristol
country: United Kingdom
facility: Investigative Site GB005
city: Cardiff
country: United Kingdom
facility: Investigative Site GB001
city: Harrogate
country: United Kingdom
facility: Investigative Site GB004
city: Ipswich
country: United Kingdom
facility: Investigative Site GB002
city: London
country: United Kingdom
facility: Investigative Site GB006
city: Redhill
country: United Kingdom
facility: Investigative Site GB003
Study officials:
affiliation: Incyte Corporation
name: Incyte Study Monitor
role: STUDY_DIRECTOR
References: