Clinical trial NCT05620836: A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa (HS)
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
HS
INCB054707
Povorcitinib
Acne inversa
Hidradenitis
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2022-11-17
Enrollment: 619
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:

* Male and female participants ≥ 18 years of age.
* Diagnosis of moderate to severe HS ≥ 3 months prior to Screening visit.
* HS lesions present in ≥ 2 distinct anatomic areas, 1 of which must be at least Hurley Stage II or Hurley Stage III, at both the Screening and Baseline visits.
* Total abscess and inflammatory nodule (AN) count ≥ 5 at both the Screening and Baseline visits.
* History of inadequate response to an appropriate course of at least 1 conventional systemic therapy for HS (or demonstrated intolerance to, or have a contraindication to, a conventional systemic therapy for HS)
* Agree to not use certain topical antiseptics on the areas affected by HS lesions during the placebo-controlled period.
* Willingness to avoid pregnancy or fathering children.
* Other inclusion criteria apply.

Exclusion Criteria:

* Draining tunnel count of \> 20 at Screening or Baseline visits.
* Women who are pregnant (or who are considering pregnancy) or breastfeeding.
* Medical history including thrombocytopenia, coagulopathy or platelet dysfunction; venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, stroke, moderate to severe heart failure, cerebrovascular accident, myocardial infarction, or other significant cardiovascular diseases; Q-wave interval abnormalities; disseminated herpes zoster or dermatomal herpes zoster; disseminated herpes simplex; chronic/recurrent infections; malignancies.
* Evidence of infection with TB, HBV, HCV or HIV.
* History of failure to JAK inhibitor treatment of any inflammatory disease.
* Laboratory values outside of the protocol-defined ranges.
* Other 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 at Week 12 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
timeFrame: 54 weeks
measure: Mean change from baseline in abscess count
timeFrame: 54 weeks
measure: Percentage change from baseline in abscess count
timeFrame: 54 weeks
measure: Mean change from baseline in inflammatory nodule count
timeFrame: 54 weeks
measure: Percentage change from baseline in inflammatory nodule count
timeFrame: 54 weeks
measure: Mean change from baseline in draining tunnel count
timeFrame: 54 weeks
measure: Percentage change from baseline in draining tunnel count
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: Scottsdale
country: United States
facility: Investigative Site US240
state: Arizona
city: Scottsdale
country: United States
facility: Investigative Site US237
state: Arizona
city: Arkansas
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facility: Investigative Site US214
state: Arkansas
city: Fayetteville
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facility: Investigative Site US242
state: Arkansas
city: Los Angeles
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facility: Investigative Site US223
state: California
city: San Diego
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facility: Investigative Site US226
state: California
city: San Francisco
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facility: Investigative Site US222
state: California
city: Washington
country: United States
facility: Investigative Site US233
state: District of Columbia
city: Brandon
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facility: Investigative Site US228
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city: Margate
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facility: Investigative Site US227
state: Florida
city: Miami
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facility: Investigative Site US204
state: Florida
city: Miami
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facility: Investigative Site US236
state: Florida
city: Ocala
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facility: Investigative Site US200
state: Florida
city: Tampa
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facility: Investigative Site US201
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city: West Dundee
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facility: Investigative Site US220
state: Illinois
city: Indianapolis
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state: Indiana
city: Iowa City
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facility: Investigative Site US241
state: Iowa
city: Louisville
country: United States
facility: Investigative Site US209
state: Kentucky
city: Metairie
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facility: Investigative Site US207
state: Louisiana
city: New Orleans
country: United States
facility: Investigative Site US229
state: Louisiana
city: Baltimore
country: United States
facility: Investigative Site US224
state: Maryland
city: Beverly
country: United States
facility: Investigative Site US208
state: Massachusetts
city: Quincy
country: United States
facility: Investigative Site US221
state: Massachusetts
city: Detroit
country: United States
facility: Investigative Site US213
state: Michigan
city: Waterford
country: United States
facility: Investigative Site US217
state: Michigan
city: Minneapolis
country: United States
facility: Investigative Site US212
state: Minnesota
city: Omaha
country: United States
facility: Investigative Site US239
state: Nebraska
city: Hightstown
country: United States
facility: Investigative Site US230
state: New Jersey
city: New York
country: United States
facility: Investigative Site US202
state: New York
city: Rochester
country: United States
facility: Investigative Site US210
state: New York
city: Chapel Hill
country: United States
facility: Investigative Site US205
state: North Carolina
city: Bexley
country: United States
facility: Investigative Site US215
state: Ohio
city: Columbus
country: United States
facility: Investigative Site US203
state: Ohio
city: Murfreesboro
country: United States
facility: Investigative Site US232
state: Tennessee
city: Arlington
country: United States
facility: Investigative Site US235
state: Texas
city: Bellaire
country: United States
facility: Investigative Site US218
state: Texas
city: Pflugerville
country: United States
facility: Investigative Site US238
state: Texas
city: San Antonio
country: United States
facility: Investigative Site US234
state: Texas
city: Kogarah
country: Australia
facility: Investigative Site AU205
state: New South Wales
city: Kotara
country: Australia
facility: Investigative Site AU203
state: New South Wales
city: Liverpool
country: Australia
facility: Investigative Site AU200
state: New South Wales
city: Benowa
country: Australia
facility: Investigative Site AU202
state: Queensland
city: Woolloongabba
country: Australia
facility: Investigative Site AU206
state: Queensland
city: Woolloongabba
country: Australia
facility: Investigative Site AU207
state: Queensland
city: Carlton
country: Australia
facility: Investigative Site AU201
state: Victoria
city: Melbourne
country: Australia
facility: Investigative Site AU204
state: Victoria
city: Sofia
country: Bulgaria
facility: Investigative Site BG203
city: Sofia
country: Bulgaria
facility: Investigative Site BG202
city: Sofia
country: Bulgaria
facility: Investigative Site BG200
city: Sofia
country: Bulgaria
facility: Investigative Site BG204
city: Stara Zagora
country: Bulgaria
facility: Investigative Site BG201
city: Calgary
country: Canada
facility: Investigative Site CA202
state: Alberta
city: Edmonton
country: Canada
facility: Investigative Site CA204
state: Alberta
city: Surrey
country: Canada
facility: Investigative Site CA200
state: British Columbia
city: Fredericton
country: Canada
facility: Investigative Site CA205
state: New Brunswick
city: Mississauga
country: Canada
facility: Investigative Site CA207
state: Ontario
city: Richmond Hill
country: Canada
facility: Investigative Site CA208
state: Ontario
city: St-jérôme
country: Canada
facility: Investigative Site CA206
state: Quebec
city: St. John's
country: Canada
facility: Investigative Site CA203
city: Roskilde
country: Denmark
facility: Investigative Site DK201
city: Århus N
country: Denmark
facility: Investigative Site DK200
city: Antony
country: France
facility: Investigative Site FR200
city: Dijon
country: France
facility: Investigative Site FR205
city: Lyon
country: France
facility: Investigative Site FR204
city: Nice Cedex 3
country: France
facility: Investigative Site FR203
city: Reims
country: France
facility: Investigative Site FR206
city: Rouen Cedex
country: France
facility: Investigative Site FR202
city: Toulon
country: France
facility: Investigative Site FR201
city: Frankfurt Am Main
country: Germany
facility: Investigative Site US225
state: MA
city: Berlin
country: Germany
facility: Investigative Site DE202
city: Bochum
country: Germany
facility: Investigative Site DE203
city: Dessau
country: Germany
facility: Investigative Site DE201
city: Erlangen
country: Germany
facility: Investigative Site DE207
city: Gottingen
country: Germany
facility: Investigative Site DE208
city: Heidelberg
country: Germany
facility: Investigative Site DE205
city: Kiel
country: Germany
facility: Investigative Site DE200
city: Luebeck
country: Germany
facility: Investigative Site DE204
city: Mainz
country: Germany
facility: Investigative Site DE206
city: Ancona
country: Italy
facility: Investigative Site IT200
city: Brescia
country: Italy
facility: Investigative Site IT204
city: Catania
country: Italy
facility: Investigative Site IT207
city: Milano
country: Italy
facility: Investigative Site IT202
city: Napoli
country: Italy
facility: Investigative Site IT203
city: Pisa
country: Italy
facility: Investigative Site IT206
city: Roma
country: Italy
facility: Investigative Site IT205
city: Rozzano
country: Italy
facility: Investigative Site IT201
city: Lublin
country: Poland
facility: Investigative Site PL203
city: Rzeszow
country: Poland
facility: Investigative Site PL200
city: Warszawa
country: Poland
facility: Investigative Site PL201
city: Warszawa
country: Poland
facility: Investigative Site PL202
city: Alicante
country: Spain
facility: Investigative Site ES203
city: Las Palmas de Gran Canaria
country: Spain
facility: Investigative Site ES202
city: Madrid
country: Spain
facility: Investigative Site ES204
city: Madrid
country: Spain
facility: Investigative Site ES201
city: Madrid
country: Spain
facility: Investigative Site ES205
city: Manises
country: Spain
facility: Investigative Site ES200
city: Birmingham
country: United Kingdom
facility: Investigative Site GB202
city: Dudley
country: United Kingdom
facility: Investigative Site GB200
city: Leeds
country: United Kingdom
facility: Investigative Site GB201
city: London
country: United Kingdom
facility: Investigative Site GB204
city: Salford
country: United Kingdom
facility: Investigative Site GB203
Study officials:
References: