A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa (HS)
- Conditions
- Hidradenitis Suppurativa (HS)
- Interventions
- Drug: Placebo
- Registration Number
- NCT05620836
- Lead Sponsor
- Incyte Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 619
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Povorcitinib Dose A Povorcitinib Participants will receive Povorcitinib Dose A for 54 weeks. Placebo Placebo Participants will receive Placebo for 12 weeks, followed by Povorcitinib (Dose A or Dose B) for 42 weeks. Povorcitinib Dose B Povorcitinib Participants will receive Povorcitinib Dose B for 54 weeks.
- Primary Outcome Measures
Name Time Method Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR) Week 12 HiSCR is defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.
- Secondary Outcome Measures
Name Time Method Mean change from baseline in Dermatology Life Quality Index (DLQI) score 54 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.
Extension Period: Proportion of participants who achieve HiSCR Week 54 HiSCR is defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.
Proportion of participants who achieve Skin Pain NRS30 at Week 12 among participants with baseline Skin Pain NRS score ≥ 3. Week 12 Participants with a Skin Pain score of at least 3 at baseline and who achieve at Week 12 Skin Pain NRS30, defined as at least a 30% reduction and at least 1-unit reduction from baseline in the Skin Pain NRS.
Proportion of participants with a ≥ 4-point increase from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) score Week 12 Participants with a baseline FACIT-F score ≤ 48 and who experience at least a 4-point increase in FACIT-F score at Week 12, relative to baseline. The FACIT-F scale is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days, with scores ranging from 0 (worst fatigue) to 52 (no fatigue).
Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) Week 12 HiSCR75 is defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.
Proportion of participants with flare 12 Weeks Participants who experience at least 1 flare over 12 weeks; flare is defined as at least a 25% increase in the total abscess and inflammatory nodule count with a minimum increase of 2 relative to baseline.
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 Week 12 Participants with a Skin Pain score of at least 3 at baseline and who experience at least a 3-point decrease in Skin Pain score at Week 12, relative to baseline. Skin Pain is an 11-point NRS, ranging from 0 (no skin pain) to 10 (worst skin pain).
Mean change from baseline in abscess count 54 weeks Defined as mean change of abscess(es) count relative to baseline.
Mean change from baseline in draining tunnel count 54 weeks Defined as mean change of draining tunnel count relative to baseline.
Percentage change from baseline in draining tunnel count 54 weeks Defined as Percent change from baseline in number of draining tunnel(s)
Percentage change from baseline in abscess count 54 weeks Percent Change from baseline in number of abscess(es)
Mean change from baseline in inflammatory nodule count 54 weeks Defined as mean change of inflammatory nodule count relative to baseline.
Percentage change from baseline in inflammatory nodule count 54 weeks Defined as percent change from baseline in number of inflammatory nodule(s)
Extension Period: Proportion of participants who achieve HiSCR75 Week 54 HiSCR75 is defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.
Extension Period: Proportion of participants with flare From Week 12 through Week 54 Participants who experience at least 1 flare over the period under assessment; flare is defined as at least a 25% increase in the total abscess and inflammatory nodule count with a minimum increase of 2 relative to baseline
Extension Period: Proportion of participants who achieved Skin Pain NRS30 among participants with baseline Skin Pain NRS score ≥ 3. Week 54 Participants with a Skin Pain score of at least 3 at baseline and who achieve Skin Pain NRS30, defined as at least a 30% reduction and at least 1-unit reduction from baseline in the Skin Pain NRS.
Extension Period: Proportion of participants who achieve maintenance of HiSCR or greater response at each visit From Week 12 through Week 54 Maintenance of response defined as participants who achieve HiSCR at Week 12 and maintain it or achieve greater response at each visit during the EXT period.
Extension Period: Proportion of participants who achieve maintenance of HiSCR75 or greater response at each visit From Week 12 through Week 54 Maintenance of response defined as participants who achieve HiSCR75 at Week 12 and maintain it or achieve greater response at each visit during the EXT period.
Trial Locations
- Locations (101)
Investigative Site US240
🇺🇸Scottsdale, Arizona, United States
Investigative Site US237
🇺🇸Scottsdale, Arizona, United States
Investigative Site US214
🇺🇸Arkansas, Arkansas, United States
Investigative Site US242
🇺🇸Fayetteville, Arkansas, United States
Investigative Site US223
🇺🇸Los Angeles, California, United States
Investigative Site US226
🇺🇸San Diego, California, United States
Investigative Site US222
🇺🇸San Francisco, California, United States
Investigative Site US233
🇺🇸Washington, District of Columbia, United States
Investigative Site US228
🇺🇸Brandon, Florida, United States
Investigative Site US227
🇺🇸Margate, Florida, United States
Investigative Site US204
🇺🇸Miami, Florida, United States
Investigative Site US236
🇺🇸Miami, Florida, United States
Investigative Site US200
🇺🇸Ocala, Florida, United States
Investigative Site US201
🇺🇸Tampa, Florida, United States
Investigative Site US220
🇺🇸West Dundee, Illinois, United States
Investigative Site US206
🇺🇸Indianapolis, Indiana, United States
Investigative Site US241
🇺🇸Iowa City, Iowa, United States
Investigative Site US209
🇺🇸Louisville, Kentucky, 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 US208
🇺🇸Beverly, Massachusetts, United States
Investigative Site US221
🇺🇸Quincy, Massachusetts, United States
Investigative Site US213
🇺🇸Detroit, Michigan, United States
Investigative Site US217
🇺🇸Waterford, Michigan, United States
Investigative Site US212
🇺🇸Minneapolis, Minnesota, United States
Investigative Site US239
🇺🇸Omaha, Nebraska, United States
Investigative Site US230
🇺🇸Hightstown, New Jersey, 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 US203
🇺🇸Columbus, Ohio, 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 US238
🇺🇸Pflugerville, Texas, United States
Investigative Site US234
🇺🇸San Antonio, Texas, 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 AU202
🇦🇺Benowa, Queensland, 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 BG203
🇧🇬Sofia, Bulgaria
Investigative Site BG202
🇧🇬Sofia, Bulgaria
Investigative Site BG200
🇧🇬Sofia, Bulgaria
Investigative Site BG204
🇧🇬Sofia, Bulgaria
Investigative Site BG201
🇧🇬Stara Zagora, Bulgaria
Investigative Site CA202
🇨🇦Calgary, Alberta, Canada
Investigative Site CA204
🇨🇦Edmonton, Alberta, Canada
Investigative Site CA200
🇨🇦Surrey, British Columbia, Canada
Investigative Site CA205
🇨🇦Fredericton, New Brunswick, Canada
Investigative Site CA207
🇨🇦Mississauga, Ontario, Canada
Investigative Site CA208
🇨🇦Richmond Hill, Ontario, Canada
Investigative Site CA206
🇨🇦St-jérôme, Quebec, Canada
Investigative Site CA203
🇨🇦St. John's, Canada
Investigative Site DK201
🇩🇰Roskilde, Denmark
Investigative Site DK200
🇩🇰Århus N, Denmark
Investigative Site FR200
🇫🇷Antony, France
Investigative Site FR205
🇫🇷Dijon, France
Investigative Site FR204
🇫🇷Lyon, France
Investigative Site FR203
🇫🇷Nice Cedex 3, France
Investigative Site FR206
🇫🇷Reims, France
Investigative Site FR202
🇫🇷Rouen Cedex, France
Investigative Site FR201
🇫🇷Toulon, France
Investigative Site US225
🇩🇪Frankfurt Am Main, MA, Germany
Investigative Site DE202
🇩🇪Berlin, Germany
Investigative Site DE203
🇩🇪Bochum, Germany
Investigative Site DE201
🇩🇪Dessau, Germany
Investigative Site DE207
🇩🇪Erlangen, Germany
Investigative Site DE208
🇩🇪Gottingen, Germany
Investigative Site DE205
🇩🇪Heidelberg, Germany
Investigative Site DE200
🇩🇪Kiel, Germany
Investigative Site DE204
🇩🇪Luebeck, Germany
Investigative Site DE206
🇩🇪Mainz, Germany
Investigative Site IT200
🇮🇹Ancona, Italy
Investigative Site IT204
🇮🇹Brescia, Italy
Investigative Site IT207
🇮🇹Catania, Italy
Investigative Site IT202
🇮🇹Milano, Italy
Investigative Site IT203
🇮🇹Napoli, Italy
Investigative Site IT206
🇮🇹Pisa, Italy
Investigative Site IT205
🇮🇹Roma, Italy
Investigative Site IT201
🇮🇹Rozzano, Italy
Investigative Site PL203
🇵🇱Lublin, Poland
Investigative Site PL200
🇵🇱Rzeszow, Poland
Investigative Site PL201
🇵🇱Warszawa, Poland
Investigative Site PL202
🇵🇱Warszawa, Poland
Investigative Site ES203
🇪🇸Alicante, 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 ES200
🇪🇸Manises, 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