Clinical trial NCT06212999: A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa
Official title: A Phase 3, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hidradenitis Suppurativa (HS)
Keywords: Hidradenitis Suppurativa
Hidradenitis
Acne inversa
HS
Povorcitinib
Long-Term Extension (LTE)
INCB054707
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2024-01-19
Enrollment: 960
Sex: ALL
Minimum age (years): 18
Standard ages: 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 long-term safety and efficacy of povorcitinib in participants with moderate to severe hidradenitis suppurativa who completed the 54 weeks of study treatment within the originating parent Phase 3 studies (INCB 54707-301 \[NCT05620823\] or INCB 54707-302 \[NCT05620836\]).


Eligibility criteria: Inclusion Criteria:

* Completion of the study treatment period of the originating parent study (INCB 54707-301 or INCB 54707-302).
* Agreement to use contraception.
* Willing and able to comply with the study protocol and procedures.
* Further inclusion criteria apply.

Exclusion Criteria:

* Participation in the extension study could expose the participant to an undue safety risk.
* Women who are pregnant (or who are considering pregnancy) or breastfeeding.
* Further exclusion criteria apply.

Primary outcomes:
measure: Proportion of participants with Treatment-Emergent Adverse Events (TEAEs)
timeFrame: up to approximately 56 weeks
Secondary outcomes:
measure: Proportion of participants with Serious Treatment-Emergent Adverse Events (TEAEs)
timeFrame: up to approximately 56 weeks
measure: Proportion of participants with TEAEs leading to study drug discontinuation
timeFrame: up to approximately 56 weeks
measure: Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR)
timeFrame: up to approximately 56 weeks
measure: Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
timeFrame: up to approximately 56 weeks
measure: Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 90 (HiSCR90)
timeFrame: up to approximately 56 weeks
measure: Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 100 (HiSCR100)
timeFrame: up to approximately 56 weeks
measure: Proportion of participants with flare at each visit
timeFrame: up to approximately 56 weeks
measure: Time to first flare
timeFrame: up to approximately 56 weeks
measure: Mean change from baseline of parent study in Hidradenitis Suppurativa Quality of Life (HiSQoL) score at each visit
timeFrame: up to approximately 56 weeks
measure: Mean change from baseline of parent study in Dermatology Life Quality Index (DLQI) score at each visit
timeFrame: up to approximately 56 weeks
measure: Proportion of participants with no increase in abscess and inflammatory nodule (AN) count relative to Week 54 at each visit
timeFrame: up to approximately 56 weeks
measure: Proportion of participants with no increase in abscess, inflammatory nodule, and draining tunnel (ANdT) count relative to Week 54 at each visit
timeFrame: up to approximately 56 weeks
measure: Proportion of participants with no increase in draining tunnel count relative to Week 54 at each visit
timeFrame: up to approximately 56 weeks
measure: Proportion of participants with a total AN count of 0, 1, or 2 at each visit
timeFrame: up to approximately 56 weeks
measure: Proportion of participants with a total ANdT count of 0, 1, or 2 at each visit
timeFrame: up to approximately 56 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Investigative Site US303
state: Arizona
city: Scottsdale
country: United States
facility: Investigative Site US240
state: Arizona
city: Fort Smith
country: United States
facility: Investigative Site US307
state: Arkansas
city: Rogers
country: United States
facility: Investigative Site US214
state: Arkansas
city: Laguna Niguel
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facility: Investigative Site US315
state: California
city: Los Angeles
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city: Oakland
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city: Miami
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city: Quincy
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city: Waterford
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facility: Investigative Site US217
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city: Saint Louis
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city: Omaha
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city: Portsmouth
country: United States
facility: Investigative Site US318
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city: East Windsor
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city: Cincinnati
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city: Murfreesboro
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facility: Investigative Site US232
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facility: Investigative Site US235
state: Texas
city: Bellaire
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facility: Investigative Site US218
state: Texas
city: Bellaire
country: United States
facility: Investigative Site US340
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city: Pflugerville
country: United States
facility: Investigative Site US238
state: Texas
city: Plano
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facility: Investigative Site US300
state: Texas
city: San Antonio
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city: Norfolk
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state: Virginia
city: Spokane
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state: Washington
city: Kogarah
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city: Kotara
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state: New South Wales
city: Liverpool
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city: Woolloongabba
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city: Woolloongabba
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city: Carlton
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city: Melbourne
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city: Inssbruck
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facility: Investigative Site AT306
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country: Austria
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country: Belgium
facility: Investigative Site BE300
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country: Belgium
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country: Belgium
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country: Bulgaria
facility: Investigative Site BG204
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country: Bulgaria
facility: Investigative Site BG201
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country: Canada
facility: Investigative Site CA202
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city: Edmonton
country: Canada
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state: British Columbia
city: Winnipeg
country: Canada
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state: Manitoba
city: Fredericton
country: Canada
facility: Investigative Site CA205
state: New Brunswick
city: Barrie
country: Canada
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city: Hamilton
country: Canada
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city: London
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city: Mississauga
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city: Peterborough
country: Canada
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city: Richmond Hill
country: Canada
facility: Investigative Site CA208
state: Ontario
city: Montreal
country: Canada
facility: Investigative Site CA307
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city: St-jérôme
country: Canada
facility: Investigative Site CA206
state: Quebec
city: St. John's
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country: Czechia
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country: Czechia
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country: Denmark
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country: Denmark
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country: France
facility: Investigative Site FR303
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country: France
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city: Hamburg
country: Germany
facility: Investigative Site DE303
city: Hannover
country: Germany
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city: Merzig
country: Germany
facility: Investigative Site DE206
city: Athens
country: Greece
facility: Investigative Site GR300
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country: Greece
facility: Investigative Site GR303
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country: Greece
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country: Italy
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country: Italy
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country: Italy
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city: Ostrowiec Swietokrzyski
country: Poland
facility: Investigative Site PL304
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: Wroclaw
country: Poland
facility: Investigative Site PL301
city: Wroclaw
country: Poland
facility: Investigative Site PL302
city: Alicante
country: Spain
facility: Investigative Site ES203
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: 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: Madrid
country: Spain
facility: Investigative Site ES305
city: Manises
country: Spain
facility: Investigative Site ES200
city: Pontevedra
country: Spain
facility: Investigative Site ES300
city: Santiago de Compostela
country: Spain
facility: Investigative Site ES304
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:
affiliation: Incyte Corporation
name: Incyte Medical Monitor
role: STUDY_DIRECTOR
References: