A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa
- Registration Number
- NCT06212999
- Lead Sponsor
- Incyte Corporation
- 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 \[NCT05620836\]).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 960
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort A Povorcitinib Povorcitinib at the protocol-defined dose strength based on cohort assignment. Cohort B Povorcitinib Povorcitinib at the protocol-defined dose strength based on cohort assignment. Cohort C Povorcitinib Povorcitinib at the protocol-defined dose strength based on cohort assignment.
- Primary Outcome Measures
Name Time Method Proportion of participants with Treatment-Emergent Adverse Events (TEAEs) up to approximately 56 weeks TEAE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug.
- Secondary Outcome Measures
Name Time Method Proportion of participants with Serious Treatment-Emergent Adverse Events (TEAEs) up to approximately 56 weeks Serious TEAE is defined as any untoward medical occurrence that, at any dose, meet at least one of the following criteria: (a) results in death; (b) is life-threatening; (c) requires inpatient hospitalization or prolongation of existing hospitalization; (d) results in persistent or significant disability/incapacity; (e) is a congenital anomaly/birth defect; (f) is an important medical event.
Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 90 (HiSCR90) up to approximately 56 weeks HiSCR90 is defined as at least a 90% reduction from baseline of parent study in the total AN count, with no increase from baseline of parent study in abscess or draining tunnel count.
Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 100 (HiSCR100) up to approximately 56 weeks HiSCR100 is defined as a 100% reduction from baseline of parent study in the total AN count, with no increase from baseline of parent study in abscess or draining tunnel count.
Proportion of participants with flare at each visit up to approximately 56 weeks Flare is defined as at least a 25% increase in the total AN count with a minimum increase of 2 ANs relative to Week 54.
Mean change from baseline of parent study in Hidradenitis Suppurativa Quality of Life (HiSQoL) score at each visit up to approximately 56 weeks The HiSQoL is a HS-specific, health-related quality of life (QoL) instrument. The HiSQoL total score ranges from 0 to 68, with higher scores indicating higher disease impact on QoL.
Proportion of participants with no increase in abscess, inflammatory nodule, and draining tunnel (ANdT) count relative to Week 54 at each visit up to approximately 56 weeks ANdT count is defined as the total sum of abscesses, inflammatory nodules, and draining tunnels.
Mean change from baseline of parent study in Dermatology Life Quality Index (DLQI) score at each visit up to approximately 56 weeks The DLQI is a skin disease specific questionnaire aimed at the evaluation of how symptoms and treatment affect participants' health-related quality of life (QoL). The DLQI total score ranges from 0 to 30, with higher scores indicating lower skin health related QoL.
Proportion of participants with TEAEs leading to study drug discontinuation up to approximately 56 weeks Defined as any TEAE that leads to discontinuation of study drug.
Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR) up to approximately 56 weeks HiSCR is defined as at least a 50% reduction from baseline of parent study in the total abscess and inflammatory nodule (AN) count, with no increase from baseline of parent study in abscess or draining tunnel count.
Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) up to approximately 56 weeks HiSCR75 is defined as at least a 75% reduction from baseline of parent study in the total AN count, with no increase from baseline of parent study in abscess or draining tunnel count.
Time to first flare up to approximately 56 weeks Time to first flare during the long-term extension study.
Proportion of participants with no increase in abscess and inflammatory nodule (AN) count relative to Week 54 at each visit up to approximately 56 weeks Proportion of participants with no increase in draining tunnel count relative to Week 54 at each visit up to approximately 56 weeks Proportion of participants with a total AN count of 0, 1, or 2 at each visit up to approximately 56 weeks AN count defined as the total sum of abscesses and inflammatory nodules.
Proportion of participants with a total ANdT count of 0, 1, or 2 at each visit up to approximately 56 weeks ANdT count is defined as the total sum of abscesses, inflammatory nodules, and draining tunnels.
Trial Locations
- Locations (172)
Investigative Site ES301
🇪🇸Granada, Spain
Investigative Site DE301
🇩🇪Frankfurt, Germany
Investigative Site DE208
🇩🇪Goettingen, Germany
Investigative Site DE303
🇩🇪Hamburg, Germany
Investigative Site DE300
🇩🇪Hannover, Germany
Investigative Site DE205
🇩🇪Heidelberg, Germany
Investigative Site DE200
🇩🇪Kiel, Germany
Investigative Site DE307
🇩🇪Memmingen, Germany
Investigative Site DE206
🇩🇪Merzig, Germany
Investigative Site GR300
🇬🇷Athens, Greece
Investigative Site GR303
🇬🇷Athens, Greece
Investigative Site JP301
🇯🇵Ginowan-shi, Japan
Investigative Site JP304
🇯🇵Itabashi-ku, Japan
Investigative Site BG200
🇧🇬Sofia, Bulgaria
Investigative Site BG204
🇧🇬Sofia, Bulgaria
Investigative Site FR205
🇫🇷Dijon, France
Investigative Site FR307
🇫🇷Le Mans Cedex 9, France
Investigative Site FR206
🇫🇷Reims, France
Investigative Site FR202
🇫🇷Rouen Cedex, France
Investigative Site DE203
🇩🇪Bochum, Germany
Investigative Site DE305
🇩🇪Darmstadt, Germany
Investigative Site DE201
🇩🇪Dessau-rosslau, Germany
Investigative Site DE302
🇩🇪Dresden, Germany
Investigative Site DE306
🇩🇪Duesseldorf, Germany
Investigative Site FR204
🇫🇷Lyon Cedex 03, France
Investigative Site FR304
🇫🇷Marseille Cedex 5, France
Investigative Site BG201
🇧🇬Stara Zagora, Bulgaria
Investigative Site DE207
🇩🇪Erlangen, Germany
Investigative Site CA202
🇨🇦Calgary, Alberta, Canada
Investigative Site DK201
🇩🇰Roskilde, Denmark
Investigative Site FR305
🇫🇷Bordeaux, France
Investigative Site FR303
🇫🇷Brest Cedex 2, France
Investigative Site US320
🇺🇸Hollywood, Florida, United States
Investigative Site US316
🇺🇸Maitland, Florida, United States
Investigative Site DK200
🇩🇰Aarhus, Denmark
Investigative Site US303
🇺🇸Phoenix, Arizona, United States
Investigative Site US240
🇺🇸Scottsdale, Arizona, United States
Investigative Site US307
🇺🇸Fort Smith, Arkansas, United States
Investigative Site US214
🇺🇸Rogers, Arkansas, United States
Investigative Site US315
🇺🇸Laguna Niguel, California, United States
Investigative Site US223
🇺🇸Los Angeles, California, United States
Investigative Site US222
🇺🇸Oakland, California, United States
Investigative Site US226
🇺🇸San Diego, California, United States
Investigative Site US233
🇺🇸Washington, District of Columbia, United States
Investigative Site US228
🇺🇸Brandon, Florida, United States
Investigative Site US309
🇺🇸Clearwater, Florida, United States
Investigative Site US317
🇺🇸Hialeah, Florida, United States
Investigative Site US306
🇺🇸Hollywood, Florida, United States
Investigative Site BG202
🇧🇬Sofia, Bulgaria
Investigative Site FR302
🇫🇷Nantes, France
Investigative Site US227
🇺🇸Margate, Florida, United States
Investigative Site US204
🇺🇸Miami, Florida, United States
Investigative Site US236
🇺🇸Miami, Florida, United States
Investigative Site US321
🇺🇸North Miami Beach, Florida, United States
Investigative Site US200
🇺🇸Ocala, Florida, United States
Investigative Site US201
🇺🇸Tampa, Florida, United States
Investigative Site US311
🇺🇸Marietta, Georgia, United States
Investigative Site US220
🇺🇸West Dundee, Illinois, United States
Investigative Site US206
🇺🇸Indianapolis, Indiana, United States
Investigative Site US337
🇺🇸Indianapolis, Indiana, United States
Investigative Site US341
🇺🇸Bowling Green, Kentucky, United States
Investigative Site US209
🇺🇸Louisville, Kentucky, United States
Investigative Site US305
🇺🇸Baton Rouge, Louisiana, United States
Investigative Site US207
🇺🇸Metairie, Louisiana, United States
Investigative Site US229
🇺🇸New Orleans, Louisiana, United States
Investigative Site US224
🇺🇸Baltimore, Maryland, United States
Investigative Site US325
🇺🇸Marriottsville, Maryland, United States
Investigative Site US225
🇺🇸Boston, Massachusetts, United States
Investigative Site US304
🇺🇸Boston, Massachusetts, United States
Investigative Site US310
🇺🇸Brighton, Massachusetts, United States
Investigative Site US221
🇺🇸Quincy, Massachusetts, United States
Investigative Site US213
🇺🇸Fort Gratiot, Michigan, United States
Investigative Site US217
🇺🇸Waterford, Michigan, United States
Investigative Site US212
🇺🇸Minneapolis, Minnesota, United States
Investigative Site US302
🇺🇸Saint Louis, Missouri, United States
Investigative Site US239
🇺🇸Omaha, Nebraska, United States
Investigative Site US318
🇺🇸Portsmouth, New Hampshire, United States
Investigative Site US230
🇺🇸East Windsor, New Jersey, United States
Investigative Site US324
🇺🇸Kew Gardens, New York, United States
Investigative Site US202
🇺🇸New York, New York, United States
Investigative Site US210
🇺🇸Rochester, New York, United States
Investigative Site US205
🇺🇸Chapel Hill, North Carolina, United States
Investigative Site US215
🇺🇸Bexley, Ohio, United States
Investigative Site US339
🇺🇸Bexley, Ohio, United States
Investigative Site US330
🇺🇸Boardman, Ohio, United States
Investigative Site US314
🇺🇸Cincinnati, Ohio, United States
Investigative Site US312
🇺🇸Cleveland, Ohio, United States
Investigative Site US203
🇺🇸Gahanna, Ohio, United States
Investigative Site US301
🇺🇸Portland, Oregon, United States
Investigative Site US232
🇺🇸Murfreesboro, Tennessee, United States
Investigative Site US235
🇺🇸Arlington, Texas, United States
Investigative Site US218
🇺🇸Bellaire, Texas, United States
Investigative Site US340
🇺🇸Bellaire, Texas, United States
Investigative Site US238
🇺🇸Pflugerville, Texas, United States
Investigative Site US300
🇺🇸Plano, Texas, United States
Investigative Site US234
🇺🇸San Antonio, Texas, United States
Investigative Site US313
🇺🇸Norfolk, Virginia, United States
Investigative Site US308
🇺🇸Spokane, Washington, United States
Investigative Site AU205
🇦🇺Kogarah, New South Wales, Australia
Investigative Site AU203
🇦🇺Kotara, New South Wales, Australia
Investigative Site AU200
🇦🇺Liverpool, New South Wales, Australia
Investigative Site AU206
🇦🇺Woolloongabba, Queensland, Australia
Investigative Site AU207
🇦🇺Woolloongabba, Queensland, Australia
Investigative Site AU201
🇦🇺Carlton, Victoria, Australia
Investigative Site AU204
🇦🇺Melbourne, Victoria, Australia
Investigative Site AT306
🇦🇹Inssbruck, Austria
Investigative Site AT303
🇦🇹Vienna, Austria
Investigative Site AT305
🇦🇹Vienna, Austria
Investigative Site BE300
🇧🇪Brussels, Belgium
Investigative Site BE306
🇧🇪Gent, Belgium
Investigative Site BE301
🇧🇪Ghent, Belgium
Investigative Site BE302
🇧🇪Liege, Belgium
Investigative Site BG203
🇧🇬Sofia, Bulgaria
Investigative Site CA204
🇨🇦Edmonton, Alberta, Canada
Investigative Site CA200
🇨🇦Surrey, British Columbia, Canada
Investigative Site CA301
🇨🇦Winnipeg, Manitoba, Canada
Investigative Site CA205
🇨🇦Fredericton, New Brunswick, Canada
Investigative Site CA304
🇨🇦Barrie, Ontario, Canada
Investigative Site CA308
🇨🇦Hamilton, Ontario, Canada
Investigative Site CA303
🇨🇦London, Ontario, Canada
Investigative Site CA207
🇨🇦Mississauga, Ontario, Canada
Investigative Site CA302
🇨🇦Peterborough, Ontario, Canada
Investigative Site CA208
🇨🇦Richmond Hill, Ontario, Canada
Investigative Site CA307
🇨🇦Montreal, Quebec, Canada
Investigative Site CA206
🇨🇦St-jérôme, Quebec, Canada
Investigative Site CA203
🇨🇦St. John's, Canada
Investigative Site CZ301
🇨🇿Ostrava - Poruba, Czechia
Investigative Site CZ300
🇨🇿Praha 5, Czechia
Investigative Site FR203
🇫🇷Nice Cedex 3, France
Investigative Site FR300
🇫🇷Paris, France
Investigative Site FR301
🇫🇷Saint Priest En Jarez, France
Investigative Site FR306
🇫🇷Toulouse Cedex 9, France
Investigative Site DE202
🇩🇪Berlin, Germany
Investigative Site GR302
🇬🇷Thessaloniki, Greece
Investigative Site IT200
🇮🇹Ancona, Italy
Investigative Site IT207
🇮🇹Catania, Italy
Investigative Site IT202
🇮🇹Milano, Italy
Investigative Site IT206
🇮🇹Pisa, Italy
Investigative Site IT205
🇮🇹Roma, Italy
Investigative Site IT201
🇮🇹Rozzano, Italy
Investigative Site JP305
🇯🇵Kurume, Japan
Investigative Site JP300
🇯🇵Kyoto-shi, Japan
Investigative Site JP303
🇯🇵Niigata-shi, Japan
Investigative Site JP308
🇯🇵Sapporo-shi, Japan
Investigative Site JP302
🇯🇵Sendai-shi, Japan
Investigative Site JP309
🇯🇵Shinjuku-ku, Japan
Investigative Site NL302
🇳🇱Breda, Netherlands
Investigative Site NL303
🇳🇱Groningen, Netherlands
Investigative Site NL301
🇳🇱Rotterdam, Netherlands
Investigative Site PL203
🇵🇱Lublin, Poland
Investigative Site PL304
🇵🇱Ostrowiec Swietokrzyski, Poland
Investigative Site PL200
🇵🇱Rzeszow, Poland
Investigative Site PL201
🇵🇱Warszawa, Poland
Investigative Site PL202
🇵🇱Warszawa, Poland
Investigative Site PL301
🇵🇱Wroclaw, Poland
Investigative Site PL302
🇵🇱Wroclaw, Poland
Investigative Site ES203
🇪🇸Alicante, Spain
Investigative Site ES302
🇪🇸Badalona, Spain
Investigative Site ES303
🇪🇸Barcelona, Spain
Investigative Site ES202
🇪🇸Las Palmas de Gran Canaria, Spain
Investigative Site ES204
🇪🇸Madrid, Spain
Investigative Site ES201
🇪🇸Madrid, Spain
Investigative Site ES205
🇪🇸Madrid, Spain
Investigative Site ES305
🇪🇸Madrid, Spain
Investigative Site ES200
🇪🇸Manises, Spain
Investigative Site ES300
🇪🇸Pontevedra, Spain
Investigative Site ES304
🇪🇸Santiago de Compostela, Spain
Investigative Site GB202
🇬🇧Birmingham, United Kingdom
Investigative Site GB200
🇬🇧Dudley, United Kingdom
Investigative Site GB201
🇬🇧Leeds, United Kingdom
Investigative Site GB204
🇬🇧London, United Kingdom
Investigative Site GB203
🇬🇧Salford, United Kingdom