A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa

Status: Active_not_recruiting
Location: See all (102) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arkansas
Investigative Site US335
Arkansas City
Investigative Site US307
Fort Smith
Arizona
Investigative Site US303
Phoenix
California
Investigative Site US315
Laguna Niguel
Investigative Site US326
Los Angeles
Investigative Site US323
San Francisco
Florida
Investigative Site US306
Boca Raton
Investigative Site US320
Boca Raton
Investigative Site US317
Hialeah
Investigative Site US338
Margate
Investigative Site US321
North Miami Beach
Investigative Site US316
Orlando
Investigative Site US328
Tampa
Investigative Site US336
Tampa
Georgia
Investigative Site US311
Marietta
Illinois
Investigative Site US327
Chicago
Investigative Site US319
Skokie
Indiana
Investigative Site US337
Indianapolis
Kentucky
Investigative Site US341
Bowling Green
Louisiana
Investigative Site US334
Metairie
Massachusetts
Investigative Site US318
Beverly
Investigative Site US304
Boston
Investigative Site US310
Brighton
Maryland
Investigative Site US333
Baltimore
Investigative Site US325
Columbia
Missouri
Investigative Site US302
St Louis
New Mexico
Investigative Site US331
Albuquerque
New York
Investigative Site US324
Kew Gardens
Ohio
Investigative Site US339
Bexley
Investigative Site US330
Boardman
Investigative Site US314
Cincinnati
Investigative Site US312
Cleveland
Oregon
Investigative Site US301
Portland
Texas
Investigative Site US340
Bellaire
Investigative Site US300
Plano
Virginia
Investigative Site US313
Norfolk
Washington
Investigative Site US308
Spokane
Other Locations
Austria
Investigative Site AT304
Graz
Investigative Site 00A
Innsbruck
Investigative Site AT306
Innsbruck
Investigative Site AT302
Linz
Investigative Site AT300
Vienna
Investigative Site AT301
Vienna
Investigative Site AT305
Vienna
Belgium
Investigative Site BE300
Brussels
Investigative Site BE304
Brussels
Investigative Site BE301
Ghent
Investigative Site BE306
Ghent
Investigative Site BE305
Leuven
Investigative Site BE302
Liège
Investigative Site BE303
Namur
Canada
Investigative Site CA304
Barrie
Investigative Site CA308
Hamilton
Investigative Site CA306
Laval
Investigative Site CA303
London
Investigative Site CA307
Montreal
Investigative Site CA302
Peterborough
Investigative Site CA309
Québec
Investigative Site CA301
Winnipeg
France
Investigative Site FR305
Bordeaux
Investigative Site FR303
Brest
Investigative Site FR307
Le Mans
Investigative Site FR304
Marseille
Investigative Site FR302
Nantes
Investigative Site FR300
Paris
Investigative Site FR301
Saint-priest-en-jarez
Investigative Site FR306
Toulouse
Germany
Investigative Site DE305
Darmstadt
Investigative Site DE302
Dresden
Investigative Site DE306
Düsseldorf
Investigative Site DE301
Frankfurt Am Main
Investigative Site DE303
Hamburg
Investigative Site DE300
Hanover
Investigative Site DE304
Langenau
Investigative Site DE307
Memmingen
Greece
Investigative Site GR300
Athens
Investigative Site GR303
Athens
Investigative Site GR301
Thessaloniki
Investigative Site GR302
Thessaloniki
Japan
Investigative Site JP304
Itabashi-ku
Investigative Site JP305
Kurume-shi
Investigative Site JP300
Kyoto
Investigative Site JP301
Nakagami-gun
Investigative Site JP303
Niigata
Investigative Site JP307
Nishinomiya-shi
Investigative Site JP308
Sapporo
Investigative Site JP302
Sendai
Investigative Site JP309
Shinjuku-ku
Investigative Site JP306
Tsukuba
Netherlands
Investigative Site NL302
Breda
Investigative Site NL303
Groningen
Investigative Site NL301
Rotterdam
Poland
Investigative Site PL304
Ostrowiec
Investigative Site PL303
Poznan
Investigative Site PL301
Wroclaw
Investigative Site PL302
Wroclaw
Spain
Investigative Site ES302
Badalona
Investigative Site ES303
Barcelona
Investigative Site ES301
Granada
Investigative Site ES305
Madrid
Investigative Site ES300
Pontevedra
Investigative Site ES304
Santiago De Compostela
Time Frame
Start Date: 2022-12-19
Completion Date: 2026-01-30
Participants
Target number of participants: 608
Treatments
Experimental: Povorcitinib Dose A
Participants will receive Povorcitinib Dose A for 54 weeks.
Experimental: Povorcitinib Dose B
Participants will receive Povorcitinib Dose B for 54 weeks.
Placebo_comparator: Placebo
Participants will receive Placebo for 12 weeks, followed by Povorcitinib (Dose A or Dose B) for 42 weeks.
Related Therapeutic Areas
Sponsors
Leads: Incyte Corporation

This content was sourced from clinicaltrials.gov

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