Clinical trial NCT05620823: A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa
Official title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Hidradenitis Suppurativa (HS)
Keywords: Hidradenitis Suppurativa
Hidradenitis
Acne inversa
HS
INCB054707
Povorcitinib
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2022-11-17
Enrollment: 608
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized 1:1:1 to Povorcitinib Dose A, Povorcitinib Dose B, or placebo once a day (QD); participants who complete the placebo controlled (PC) 12-week period may continue to a 42-week extension(EXT) period with Povorcitinib (Dose A or Dose B) QD.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of Povorcitinib (INCB054707) in participants with moderate to severe Hidradenitis Suppurativa (HS) over a 12-week placebo controlled period, followed by a 42-week extension period.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of moderate to severe HS for at least 3 months prior to the screening visit.
* Total abscess and inflammatory nodule count of at least 5 at both the screening and baseline visits
* HS lesions in at least 2 distinct anatomical areas (examples include but are not limited to left and right axilla or left and right inguinocrural fold), 1 of which must be at least Hurley Stage II or Hurley Stage III, at both the screening and baseline visits
* Documented history of inadequate response to at least a 3-month course of at least 1 conventional systemic therapy (oral antibiotic or biologic drug) for HS (or demonstrated intolerance to, or have a contraindication to, a conventional systemic therapy for treatment of their HS).
* Agreement to NOT use topical and systemic antibiotics for treatment of HS during the placebo-controlled period.
* Agreement to NOT use a diluted bleach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on the areas affected by HS lesions during the placebo-controlled period. Note: Over-the-counter soap and water is allowed.
* Agreement to use contraception
* Willing and able to comply with the study protocol and procedures.
* Further inclusion criteria apply.

Exclusion Criteria:

* Presence of \> 20 draining tunnels (fistulas) at either the screening or baseline visit.
* Women who are pregnant (or who are considering pregnancy) or breastfeeding.
* Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, 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 ranges.
* Further exclusion criteria apply.

Primary outcomes:
measure: Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR)
timeFrame: Week 12
Secondary outcomes:
measure: Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
timeFrame: Week 12
measure: Proportion of participants with flare
timeFrame: 12 weeks
measure: Proportion of participants with a ≥ 3-point decrease in Skin Pain Numeric Rating Scale (NRS) score among participants with baseline Skin Pain NRS score ≥ 3.
timeFrame: Week 12
measure: Proportion of participants who achieve Skin Pain NRS30 among participants with baseline Skin Pain NRS score ≥ 3.
timeFrame: Week 12
measure: Proportion of participants with a ≥ 4-point increase from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT F) score
timeFrame: Week 12
measure: Mean change from baseline in Dermatology Life Quality Index (DLQI) score at each visit
timeFrame: 54 weeks
measure: Mean change from baseline in abscess count at each visit.
timeFrame: 54 weeks
measure: Percentage change from baseline in abscess count at every visit
timeFrame: 54 weeks
measure: Mean change from baseline in inflammatory nodule count at each visit
timeFrame: 54 weeks
measure: Percentage change from baseline in inflammatory nodule count at each visit.
timeFrame: 54 weeks
measure: Mean change from baseline in draining tunnel count at each visit.
timeFrame: 54 weeks
measure: Percentage change from baseline in draining tunnel count at each visit.
timeFrame: 54 weeks
measure: Extension Period: Proportion of participants who achieve HiSCR
timeFrame: Week 24
measure: Extension Period: Proportion of participants who achieve HiSCR75
timeFrame: Week 24
measure: Extension Period: Proportion of participants with flare
timeFrame: From Week 12 through Week 24
measure: Extension Period: Proportion of participants who achieved Skin Pain NRS30 among participants with baseline Skin Pain NRS score ≥ 3
timeFrame: Week 24
measure: Extension Period: Proportion of participants who achieve HiSCR
timeFrame: Week 54
measure: Extension Period: Proportion of participants who achieve HiSCR75
timeFrame: Week 54
measure: Extension Period : Proportion of participants with flare
timeFrame: From Week 12 through Week 54
measure: Extension Period: Proportion of participants who achieved Skin Pain NRS30 among participants with baseline Skin Pain NRS score ≥ 3.
timeFrame: Week 54
measure: Extension Period:Proportion of participants who achieve maintenance of HiSCR or greater response at each visit
timeFrame: From Week 12 through Week 54
measure: Extension Period : Proportion of participants who achieve maintenance of HiSCR75 or greater response at each visit
timeFrame: From Week 12 through Week 54
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Investigative Site US303
state: Arizona
city: Arkansas
country: United States
facility: Investigative Site US335
state: Arkansas
city: Fort Smith
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facility: Investigative Site US307
state: Arkansas
city: Laguna Niguel
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facility: Investigative Site US315
state: California
city: Los Angeles
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facility: Investigative Site US326
state: California
city: San Francisco
country: United States
facility: Investigative Site US323
state: California
city: Boca Raton
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facility: Investigative Site US306
state: Florida
city: Boca Raton
country: United States
facility: Investigative Site US320
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city: Hialeah
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facility: Investigative Site US317
state: Florida
city: Margate
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facility: Investigative Site US338
state: Florida
city: North Miami Beach
country: United States
facility: Investigative Site US321
state: Florida
city: Orlando
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facility: Investigative Site US316
state: Florida
city: Tampa
country: United States
facility: Investigative Site US328
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city: Tampa
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city: Marietta
country: United States
facility: Investigative Site US311
state: Georgia
city: Chicago
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state: Illinois
city: Skokie
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facility: Investigative Site US319
state: Illinois
city: Indianapolis
country: United States
facility: Investigative Site US337
state: Indiana
city: Bowling Green
country: United States
facility: Investigative Site US341
state: Kentucky
city: Metairie
country: United States
facility: Investigative Site US334
state: Louisiana
city: Baltimore
country: United States
facility: Investigative Site US333
state: Maryland
city: Columbia
country: United States
facility: Investigative Site US325
state: Maryland
city: Beverly
country: United States
facility: Investigative Site US318
state: Massachusetts
city: Boston
country: United States
facility: Investigative Site US304
state: Massachusetts
city: Brighton
country: United States
facility: Investigative Site US310
state: Massachusetts
city: Saint Louis
country: United States
facility: Investigative Site US302
state: Missouri
city: Albuquerque
country: United States
facility: Investigative Site US331
state: New Mexico
city: Kew Gardens
country: United States
facility: Investigative Site US324
state: New York
city: Bexley
country: United States
facility: Investigative Site US339
state: Ohio
city: Boardman
country: United States
facility: Investigative Site US330
state: Ohio
city: Cincinnati
country: United States
facility: Investigative Site US314
state: Ohio
city: Cleveland
country: United States
facility: Investigative Site US312
state: Ohio
city: Portland
country: United States
facility: Investigative Site US301
state: Oregon
city: Bellaire
country: United States
facility: Investigative Site US340
state: Texas
city: Plano
country: United States
facility: Investigative Site US300
state: Texas
city: Norfolk
country: United States
facility: Investigative Site US313
state: Virginia
city: Spokane
country: United States
facility: Investigative Site US308
state: Washington
city: Graz
country: Austria
facility: Investigative Site AT304
city: Innsbruck
country: Austria
facility: Investigative Site 00A
city: Innsbruck
country: Austria
facility: Investigative Site AT306
city: Linz
country: Austria
facility: Investigative Site AT302
city: Vienna
country: Austria
facility: Investigative Site AT305
city: Wien
country: Austria
facility: Investigative Site AT301
city: Wien
country: Austria
facility: Investigative Site AT300
city: Brussels
country: Belgium
facility: Investigative Site BE304
city: Bruxelles
country: Belgium
facility: Investigative Site BE300
city: Gent
country: Belgium
facility: Investigative Site BE306
city: Ghent
country: Belgium
facility: Investigative Site BE301
city: Leuven
country: Belgium
facility: Investigative Site BE305
city: Liege
country: Belgium
facility: Investigative Site BE302
city: Namur
country: Belgium
facility: Investigative Site BE303
city: Winnipeg
country: Canada
facility: Investigative Site CA301
state: Manitoba
city: Barrie
country: Canada
facility: Investigative Site CA304
state: Ontario
city: Hamilton
country: Canada
facility: Investigative Site CA308
state: Ontario
city: London
country: Canada
facility: Investigative Site CA303
state: Ontario
city: Peterborough
country: Canada
facility: Investigative Site CA302
state: Ontario
city: Laval
country: Canada
facility: Investigative Site CA306
state: Quebec
city: Montreal
country: Canada
facility: Investigative Site CA307
state: Quebec
city: Quebec
country: Canada
facility: Investigative Site CA309
city: Ostrava - Poruba
country: Czechia
facility: Investigative Site CZ301
city: Praha 5
country: Czechia
facility: Investigative Site CZ300
city: Bordeaux
country: France
facility: Investigative Site FR305
city: Brest Cedex 2
country: France
facility: Investigative Site FR303
city: Le Mans Cedex
country: France
facility: Investigative Site FR307
city: Marseille
country: France
facility: Investigative Site FR304
city: Nantes Cedex 1
country: France
facility: Investigative Site FR302
city: Paris
country: France
facility: Investigative Site FR300
city: Saint Priest En Jarez
country: France
facility: Investigative Site FR301
city: Toulouse Cedex 9
country: France
facility: Investigative Site FR306
city: Darmstadt
country: Germany
facility: Investigative Site DE305
city: Dresden
country: Germany
facility: Investigative Site DE302
city: Duesseldorf
country: Germany
facility: Investigative Site DE306
city: Frankfurt Am Main
country: Germany
facility: Investigative Site DE301
city: Hamburg
country: Germany
facility: Investigative Site DE303
city: Hannover
country: Germany
facility: Investigative Site DE300
city: Langenau
country: Germany
facility: Investigative Site DE304
city: Memmingen
country: Germany
facility: Investigative Site DE307
city: Athens
country: Greece
facility: Investigative Site GR300
city: Athens
country: Greece
facility: Investigative Site GR303
city: Thessaloniki
country: Greece
facility: Investigative Site GR301
city: Thessaloniki
country: Greece
facility: Investigative Site GR302
city: Itabashi-ku
country: Japan
facility: Investigative Site JP304
city: Kurume-shi
country: Japan
facility: Investigative Site JP305
city: Kyoto-shi
country: Japan
facility: Investigative Site JP300
city: Nakagami-gun
country: Japan
facility: Investigative Site JP301
city: Niigata-shi
country: Japan
facility: Investigative Site JP303
city: Nishinomiya-shi
country: Japan
facility: Investigative Site JP307
city: Sapporo-shi
country: Japan
facility: Investigative Site JP308
city: Sendai-shi
country: Japan
facility: Investigative Site JP302
city: Shinjuku-ku
country: Japan
facility: Investigative Site JP309
city: Tsukuba-shi
country: Japan
facility: Investigative Site JP306
city: Breda
country: Netherlands
facility: Investigative Site NL302
city: Groningen
country: Netherlands
facility: Investigative Site NL303
city: Rotterdam
country: Netherlands
facility: Investigative Site NL301
city: Ostrowiec
country: Poland
facility: Investigative Site PL304
city: Poznan
country: Poland
facility: Investigative Site PL303
city: Wroclaw
country: Poland
facility: Investigative Site PL301
city: Wroclaw
country: Poland
facility: Investigative Site PL302
city: Badalona
country: Spain
facility: Investigative Site ES302
city: Barcelona
country: Spain
facility: Investigative Site ES303
city: Granada
country: Spain
facility: Investigative Site ES301
city: Madrid
country: Spain
facility: Investigative Site ES305
city: Pontevedra
country: Spain
facility: Investigative Site ES300
city: Santiago de Compostela
country: Spain
facility: Investigative Site ES304
Study officials:
References: