A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa
- Conditions
- Hidradenitis Suppurativa (HS)
- Interventions
- Drug: Placebo
- Registration Number
- NCT05620823
- 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
- 608
- 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.
- Presence of > 20 draining tunnels (fistulas) at either the screening or baseline visit.
- Women who are pregnant (or who are considering pregnancy) or breastfeeding.
- Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.
- Laboratory values outside of the protocol-defined ranges.
- Further exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Povorcitinib Dose B Povorcitinib Participants will receive Povorcitinib Dose B 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 A Povorcitinib Participants will receive Povorcitinib Dose A 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 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 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 who achieve Skin Pain NRS30 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.
Mean change from baseline in inflammatory nodule count at each visit 54 weeks Defined as mean change of inflammatory nodule count relative to baseline.
Mean change from baseline in draining tunnel count at each visit. 54 weeks Defined as mean change of draining tunnel count 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).
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).
Mean change from baseline in Dermatology Life Quality Index (DLQI) score at each visit 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.
Mean change from baseline in abscess count at each visit. 54 weeks Defined as mean change of Abscess count relative to baseline.
Percentage change from baseline in abscess count at every visit 54 weeks Percent change from baseline in number of abscess(es)
Percentage change from baseline in inflammatory nodule count at each visit. 54 weeks Defined as percent change from baseline in number of inflammatory nodule(s)
Percentage change from baseline in draining tunnel count at each visit. 54 weeks Defined as percent change from baseline in number of draining tunnel(s)
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
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 24 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 24 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 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 at Week 24 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.
Related Research Topics
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Trial Locations
- Locations (104)
Investigative Site US303
🇺🇸Phoenix, Arizona, United States
Investigative Site US335
🇺🇸Arkansas, Arkansas, United States
Investigative Site US315
🇺🇸Laguna Niguel, California, United States
Investigative Site US307
🇺🇸Fort Smith, Arkansas, United States
Investigative Site US326
🇺🇸Los Angeles, California, United States
Investigative Site US306
🇺🇸Boca Raton, Florida, United States
Investigative Site US321
🇺🇸North Miami Beach, Florida, United States
Investigative Site US316
🇺🇸Orlando, Florida, United States
Investigative Site US328
🇺🇸Tampa, Florida, United States
Investigative Site US336
🇺🇸Tampa, Florida, United States
Investigative Site US323
🇺🇸San Francisco, California, United States
Investigative Site US320
🇺🇸Boca Raton, Florida, United States
Investigative Site US317
🇺🇸Hialeah, Florida, United States
Investigative Site US311
🇺🇸Marietta, Georgia, United States
Investigative Site US319
🇺🇸Skokie, Illinois, United States
Investigative Site US337
🇺🇸Indianapolis, Indiana, United States
Investigative Site US341
🇺🇸Bowling Green, Kentucky, United States
Investigative Site US333
🇺🇸Baltimore, Maryland, United States
Investigative Site US325
🇺🇸Columbia, Maryland, United States
Investigative Site US318
🇺🇸Beverly, Massachusetts, United States
Investigative Site US304
🇺🇸Boston, Massachusetts, United States
Investigative Site US338
🇺🇸Margate, Florida, United States
Investigative Site US327
🇺🇸Chicago, Illinois, United States
Investigative Site US334
🇺🇸Metairie, Louisiana, United States
Investigative Site US310
🇺🇸Brighton, Massachusetts, United States
Investigative Site US302
🇺🇸Saint Louis, Missouri, United States
Investigative Site US331
🇺🇸Albuquerque, New Mexico, United States
Investigative Site US324
🇺🇸Kew Gardens, New York, 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 US301
🇺🇸Portland, Oregon, United States
Investigative Site US308
🇺🇸Spokane, Washington, United States
Investigative Site AT304
🇦🇹Graz, Austria
Investigative Site 00A
🇦🇹Innsbruck, Austria
Investigative Site US340
🇺🇸Bellaire, Texas, United States
Investigative Site US300
🇺🇸Plano, Texas, United States
Investigative Site US313
🇺🇸Norfolk, Virginia, United States
Investigative Site AT306
🇦🇹Innsbruck, Austria
Investigative Site AT302
🇦🇹Linz, Austria
Investigative Site AT305
🇦🇹Vienna, Austria
Investigative Site AT301
🇦🇹Wien, Austria
Investigative Site AT300
🇦🇹Wien, Austria
Investigative Site BE304
🇧🇪Brussels, Belgium
Investigative Site BE300
🇧🇪Bruxelles, Belgium
Investigative Site BE306
🇧🇪Gent, Belgium
Investigative Site BE301
🇧🇪Ghent, Belgium
Investigative Site BE305
🇧🇪Leuven, Belgium
Investigative Site BE302
🇧🇪Liege, Belgium
Investigative Site BE303
🇧🇪Namur, Belgium
Investigative Site CA301
🇨🇦Winnipeg, Manitoba, Canada
Investigative Site CA304
🇨🇦Barrie, Ontario, Canada
Investigative Site CA308
🇨🇦Hamilton, Ontario, Canada
Investigative Site CA303
🇨🇦London, Ontario, Canada
Investigative Site CA302
🇨🇦Peterborough, Ontario, Canada
Investigative Site CA306
🇨🇦Laval, Quebec, Canada
Investigative Site CA307
🇨🇦Montreal, Quebec, Canada
Investigative Site CA309
🇨🇦Quebec, Canada
Investigative Site CZ301
🇨🇿Ostrava - Poruba, Czechia
Investigative Site CZ300
🇨🇿Praha 5, Czechia
Investigative Site FR305
🇫🇷Bordeaux, France
Investigative Site FR303
🇫🇷Brest Cedex 2, France
Investigative Site FR307
🇫🇷Le Mans Cedex, France
Investigative Site FR304
🇫🇷Marseille, France
Investigative Site FR302
🇫🇷Nantes Cedex 1, France
Investigative Site FR300
🇫🇷Paris, France
Investigative Site FR301
🇫🇷Saint Priest En Jarez, France
Investigative Site FR306
🇫🇷Toulouse Cedex 9, France
Investigative Site DE305
🇩🇪Darmstadt, Germany
Investigative Site DE302
🇩🇪Dresden, Germany
Investigative Site DE306
🇩🇪Duesseldorf, Germany
Investigative Site DE301
🇩🇪Frankfurt Am Main, Germany
Investigative Site DE303
🇩🇪Hamburg, Germany
Investigative Site DE300
🇩🇪Hannover, Germany
Investigative Site DE304
🇩🇪Langenau, Germany
Investigative Site DE307
🇩🇪Memmingen, Germany
Investigative Site GR300
🇬🇷Athens, Greece
Investigative Site GR303
🇬🇷Athens, Greece
Investigative Site GR301
🇬🇷Thessaloniki, Greece
Investigative Site GR302
🇬🇷Thessaloniki, Greece
Investigative Site JP304
🇯🇵Itabashi-ku, Japan
Investigative Site JP305
🇯🇵Kurume-shi, Japan
Investigative Site JP300
🇯🇵Kyoto-shi, Japan
Investigative Site JP301
🇯🇵Nakagami-gun, Japan
Investigative Site JP303
🇯🇵Niigata-shi, Japan
Investigative Site JP307
🇯🇵Nishinomiya-shi, Japan
Investigative Site JP308
🇯🇵Sapporo-shi, Japan
Investigative Site JP302
🇯🇵Sendai-shi, Japan
Investigative Site JP309
🇯🇵Shinjuku-ku, Japan
Investigative Site JP306
🇯🇵Tsukuba-shi, Japan
Investigative Site NL302
🇳🇱Breda, Netherlands
Investigative Site NL303
🇳🇱Groningen, Netherlands
Investigative Site NL301
🇳🇱Rotterdam, Netherlands
Investigative Site PL304
🇵🇱Ostrowiec, Poland
Investigative Site PL303
🇵🇱Poznan, Poland
Investigative Site PL301
🇵🇱Wroclaw, Poland
Investigative Site PL302
🇵🇱Wroclaw, Poland
Investigative Site ES302
🇪🇸Badalona, Spain
Investigative Site ES303
🇪🇸Barcelona, Spain
Investigative Site ES301
🇪🇸Granada, Spain
Investigative Site ES305
🇪🇸Madrid, Spain
Investigative Site ES300
🇪🇸Pontevedra, Spain
Investigative Site ES304
🇪🇸Santiago de Compostela, Spain