Clinical trial NCT06958211: Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS2)
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: 450
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:
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state: Alabama
city: Montgomery
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state: Alabama
city: Phoenix
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state: Arizona
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city: Scottsdale
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state: Arizona
city: Tucson
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state: Arizona
city: Encino
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state: California
city: Fountain Valley
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state: California
city: Los Angeles
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state: California
city: Los Angeles
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state: California
city: Northridge
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state: California
city: Tustin
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state: California
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state: Colorado
city: Farmington
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city: Miami
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city: Miami
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city: Tampa
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city: Columbus
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state: Idaho
city: Skokie
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state: Illinois
city: Plainfield
country: United States
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state: Indiana
city: Lake Charles
country: United States
facility: Investigative Site US264
state: Louisiana
city: New Orleans
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facility: Investigative Site US236
state: Louisiana
city: New Orleans
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facility: Investigative Site US326
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city: New Orleans
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facility: Investigative Site US266
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city: Gambrills
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facility: Investigative Site US254
state: Maryland
city: Marriottsville
country: United States
facility: Investigative Site US201
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city: Rochester
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facility: Investigative Site US245
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city: Huntersville
country: United States
facility: Investigative Site US259
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city: Winston-Salem
country: United States
facility: Investigative Site US263
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city: Columbus
country: United States
facility: Investigative Site US249
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city: Dublin
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facility: Investigative Site US243
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city: Mayfield Heights
country: United States
facility: Investigative Site US228
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city: Portland
country: United States
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state: Oregon
city: Plymouth Meeting
country: United States
facility: Investigative Site US226
state: Pennsylvania
city: Bluffton
country: United States
facility: Investigative Site US256
state: South Carolina
city: Mount Pleasant
country: United States
facility: Investigative Site US267
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city: Cypress
country: United States
facility: Investigative Site US260
state: Texas
city: Prosper
country: United States
facility: Investigative Site US270
state: Texas
city: Sugar Land
country: United States
facility: Investigative Site US232
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city: Arlington
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state: Virginia
city: Danville
country: United States
facility: Investigative Site US209
state: Virginia
city: Norfolk
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facility: Investigative Site US229
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city: Seattle
country: United States
facility: Investigative Site US265
state: Washington
city: Spokane
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facility: Investigative Site US224
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city: Milwaukee
country: United States
facility: Investigative Site US210
state: Wisconsin
city: Brussels
country: Belgium
facility: Investigative Site BE204
city: Gent
country: Belgium
facility: Investigative Site BE201
city: Gent
country: Belgium
facility: Investigative Site BE203
city: Leuven
country: Belgium
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city: Sevlievo
country: Bulgaria
facility: Investigative Site BG201
city: Sofia
country: Bulgaria
facility: Investigative Site BG202
city: Sofia
country: Bulgaria
facility: Investigative Site BG203
city: Edmonton
country: Canada
facility: Investigative Site CA209
state: Alberta
city: Winnipeg
country: Canada
facility: Investigative Site CA201
state: Manitoba
city: Fredericton
country: Canada
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state: New Brunswick
city: Hamilton
country: Canada
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state: Ontario
city: London
country: Canada
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state: Ontario
city: Markham
country: Canada
facility: Investigative Site CA204
state: Ontario
city: Mississauga
country: Canada
facility: Investigative Site CA205
state: Ontario
city: Saskatoon
country: Canada
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state: Saskatchewan
city: St. John's
country: Canada
facility: Investigative Site CA206
city: Reims
country: France
facility: Investigative Site FR201
city: Rouen Cedex
country: France
facility: Investigative Site FR203
city: Saint Etienne Cedex 2
country: France
facility: Investigative Site FR204
city: Toulouse Cedex 9
country: France
facility: Investigative Site FR202
city: Bad Bentheim
country: Germany
facility: Investigative Site DE207
city: Frankfurt Am Main
country: Germany
facility: Investigative Site DE201
city: Gottingen
country: Germany
facility: Investigative Site DE206
city: Hannover
country: Germany
facility: Investigative Site DE202
city: Kiel
country: Germany
facility: Investigative Site DE203
city: Langenau
country: Germany
facility: Investigative Site DE205
city: Mainz
country: Germany
facility: Investigative Site DE204
city: Amsterdam
country: Netherlands
facility: Investigative Site NL203
city: Bergen Op Zoom
country: Netherlands
facility: Investigative Site NL202
city: Rotterdam
country: Netherlands
facility: Investigative Site NL201
city: Ostrowiec Swietokrzyski
country: Poland
facility: Investigative Site PL202
city: Poznan
country: Poland
facility: Investigative Site PL204
city: Rzeszow
country: Poland
facility: Investigative Site PL201
city: Wrocaw
country: Poland
facility: Investigative Site PL203
city: Barcelona
country: Spain
facility: Investigative Site ES205
city: Barcelona
country: Spain
facility: Investigative Site ES206
city: Esplugues de Llobregat
country: Spain
facility: Investigative Site ES208
city: Granada
country: Spain
facility: Investigative Site ES201
city: Las Palmas de Gran Canaria
country: Spain
facility: Investigative Site ES202
city: Madrid
country: Spain
facility: Investigative Site ES203
city: Manises
country: Spain
facility: Investigative Site ES207
city: Santiago de Compostela
country: Spain
facility: Investigative Site ES204
Study officials:
affiliation: Incyte Corporation
name: Incyte Study Monitor
role: STUDY_DIRECTOR
References: