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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-501752-29-00 | Registry Identifier | EU CT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Povorcitinib Dose A | Experimental | Participants will receive Povorcitinib Dose A for 54 weeks. |
|
| Povorcitinib Dose B | Experimental | Participants will receive Povorcitinib Dose B for 54 weeks. |
|
| Placebo | Placebo Comparator | Participants will receive Placebo for 12 weeks, followed by Povorcitinib (Dose A or Dose B) for 42 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Povorcitinib | Drug | Oral; Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR) | 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. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) | 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. | Week 12 |
| Proportion of participants with flare |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site US303 | Phoenix | Arizona | 85006 | United States | ||
| Investigative Site US335 |
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| Label | URL |
|---|---|
| A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa | View source |
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Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
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Participants will be randomized 1:1:1 to Povorcitinib Dose A, Povorcitinib Dose B, or placebo once a day (QD); participants who complete the placebo controlled (PC) 12-week period may continue to a 42-week extension(EXT) period with Povorcitinib (Dose A or Dose B) QD.
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| Placebo | Drug | Oral; Tablet |
|
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. |
| 12 weeks |
| 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. | 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). | Week 12 |
| Proportion of participants who achieve Skin Pain NRS30 among participants with baseline Skin Pain NRS score ≥ 3. | 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. | Week 12 |
| Proportion of participants with a ≥ 4-point increase from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT F) score | 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). | Week 12 |
| Mean change from baseline in Dermatology Life Quality Index (DLQI) score at each visit | 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. | 54 weeks |
| Mean change from baseline in abscess count at each visit. | Defined as mean change of Abscess count relative to baseline. | 54 weeks |
| Percentage change from baseline in abscess count at every visit | Percent change from baseline in number of abscess(es) | 54 weeks |
| Mean change from baseline in inflammatory nodule count at each visit | Defined as mean change of inflammatory nodule count relative to baseline. | 54 weeks |
| Percentage change from baseline in inflammatory nodule count at each visit. | Defined as percent change from baseline in number of inflammatory nodule(s) | 54 weeks |
| Mean change from baseline in draining tunnel count at each visit. | Defined as mean change of draining tunnel count relative to baseline. | 54 weeks |
| Percentage change from baseline in draining tunnel count at each visit. | Defined as percent change from baseline in number of draining tunnel(s) | 54 weeks |
| Extension Period: Proportion of participants who achieve HiSCR | 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. | Week 24 |
| Extension Period: Proportion of participants who achieve HiSCR75 | 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. | Week 24 |
| Extension Period: Proportion of participants with flare | 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. | From Week 12 through Week 24 |
| Extension Period: Proportion of participants who achieved Skin Pain NRS30 among participants with baseline Skin Pain NRS score ≥ 3 | Skin Pain NRS30 defined as at least a 30% reduction and at least 1-unit reduction from baseline in the Skin Pain NRS. | Week 24 |
| Extension Period: Proportion of participants who achieve HiSCR | 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 | Week 54 |
| Extension Period: Proportion of participants who achieve HiSCR75 | 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. | Week 54 |
| Extension Period : Proportion of participants with flare | 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. | From Week 12 through Week 54 |
| Extension Period: Proportion of participants who achieved Skin Pain NRS30 among participants with baseline Skin Pain NRS score ≥ 3. | 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. | Week 54 |
| Extension Period:Proportion of participants who achieve maintenance of HiSCR or greater response at each visit | 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. | From Week 12 through Week 54 |
| Extension Period : Proportion of participants who achieve maintenance of HiSCR75 or greater response at each visit | 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. | From Week 12 through Week 54 |
| Arkansas City |
| Arkansas |
| 72758 |
| United States |
| Investigative Site US307 | Fort Smith | Arkansas | 72916 | United States |
| Investigative Site US315 | Laguna Niguel | California | 92677 | United States |
| Investigative Site US326 | Los Angeles | California | 90045 | United States |
| Investigative Site US323 | San Francisco | California | 94118 | United States |
| Investigative Site US306 | Boca Raton | Florida | 33486 | United States |
| Investigative Site US320 | Boca Raton | Florida | 33486 | United States |
| Investigative Site US317 | Hialeah | Florida | 33012-3618 | United States |
| Investigative Site US338 | Margate | Florida | 33063 | United States |
| Investigative Site US321 | North Miami Beach | Florida | 33162-4708 | United States |
| Investigative Site US316 | Orlando | Florida | 32819 | United States |
| Investigative Site US328 | Tampa | Florida | 33612 | United States |
| Investigative Site US336 | Tampa | Florida | 33613 | United States |
| Investigative Site US311 | Marietta | Georgia | 30060-1047 | United States |
| Investigative Site US327 | Chicago | Illinois | 60612 | United States |
| Investigative Site US319 | Skokie | Illinois | 60077 | United States |
| Investigative Site US337 | Indianapolis | Indiana | 46250 | United States |
| Investigative Site US341 | Bowling Green | Kentucky | 42103 | United States |
| Investigative Site US334 | Metairie | Louisiana | 70006 | United States |
| Investigative Site US333 | Baltimore | Maryland | 21287 | United States |
| Investigative Site US325 | Columbia | Maryland | 21045 | United States |
| Investigative Site US318 | Beverly | Massachusetts | 01915 | United States |
| Investigative Site US304 | Boston | Massachusetts | 02215 | United States |
| Investigative Site US310 | Brighton | Massachusetts | 02135 | United States |
| Investigative Site US302 | St Louis | Missouri | 63110 | United States |
| Investigative Site US331 | Albuquerque | New Mexico | 87102 | United States |
| Investigative Site US324 | Kew Gardens | New York | 11415 | United States |
| Investigative Site US339 | Bexley | Ohio | 43209 | United States |
| Investigative Site US330 | Boardman | Ohio | 44512 | United States |
| Investigative Site US314 | Cincinnati | Ohio | 45219 | United States |
| Investigative Site US312 | Cleveland | Ohio | 44106 | United States |
| Investigative Site US301 | Portland | Oregon | 97223 | United States |
| Investigative Site US340 | Bellaire | Texas | 77401 | United States |
| Investigative Site US300 | Plano | Texas | 75025 | United States |
| Investigative Site US313 | Norfolk | Virginia | 23502 | United States |
| Investigative Site US308 | Spokane | Washington | 99202 | United States |
| Investigative Site AT304 | Graz | 08036 | Austria |
| Investigative Site 00A | Innsbruck | 06020 | Austria |
| Investigative Site AT306 | Innsbruck | 06020 | Austria |
| Investigative Site AT302 | Linz | 04020 | Austria |
| Investigative Site AT305 | Vienna | 01090 | Austria |
| Investigative Site AT301 | Vienna | 01100 | Austria |
| Investigative Site AT300 | Vienna | 01130 | Austria |
| Investigative Site BE300 | Brussels | 01070 | Belgium |
| Investigative Site BE304 | Brussels | 01200 | Belgium |
| Investigative Site BE301 | Ghent | 09000 | Belgium |
| Investigative Site BE306 | Ghent | 09000 | Belgium |
| Investigative Site BE305 | Leuven | 03000 | Belgium |
| Investigative Site BE302 | Liège | 04000 | Belgium |
| Investigative Site BE303 | Namur | 05000 | Belgium |
| Investigative Site CA301 | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| Investigative Site CA304 | Barrie | Ontario | L4M 1G7 | Canada |
| Investigative Site CA308 | Hamilton | Ontario | L8L 3C3 | Canada |
| Investigative Site CA303 | London | Ontario | N6H 5L5 | Canada |
| Investigative Site CA302 | Peterborough | Ontario | K9J 5K2 | Canada |
| Investigative Site CA306 | Laval | Quebec | H7N 6L2 | Canada |
| Investigative Site CA307 | Montreal | Quebec | H2K 4L5 | Canada |
| Investigative Site CA309 | Québec | Quebec | G1V 4T3 | Canada |
| Investigative Site CZ301 | Ostrava - Poruba | 708 52 | Czechia |
| Investigative Site CZ300 | Prague | 150 06 | Czechia |
| Investigative Site FR305 | Bordeaux | 33000 | France |
| Investigative Site FR303 | Brest | 29609 | France |
| Investigative Site FR307 | Le Mans | 72037 | France |
| Investigative Site FR304 | Marseille | 13385 | France |
| Investigative Site FR302 | Nantes | 44093 | France |
| Investigative Site FR300 | Paris | 75010 | France |
| Investigative Site FR301 | Saint-Priest-en-Jarez | 42270 | France |
| Investigative Site FR306 | Toulouse | 31059 | France |
| Investigative Site DE305 | Darmstadt | 64283 | Germany |
| Investigative Site DE302 | Dresden | 01307 | Germany |
| Investigative Site DE306 | Düsseldorf | 40225 | Germany |
| Investigative Site DE301 | Frankfurt am Main | 60590 | Germany |
| Investigative Site DE303 | Hamburg | 20246 | Germany |
| Investigative Site DE300 | Hanover | 30519 | Germany |
| Investigative Site DE304 | Langenau | 89129 | Germany |
| Investigative Site DE307 | Memmingen | 87700 | Germany |
| Investigative Site GR300 | Athens | 12462 | Greece |
| Investigative Site GR303 | Athens | 16121 | Greece |
| Investigative Site GR301 | Thessaloniki | 54643 | Greece |
| Investigative Site GR302 | Thessaloniki | 56403 | Greece |
| Investigative Site JP304 | Itabashi-ku | 173-8610 | Japan |
| Investigative Site JP305 | Kurume-shi | 830-0011 | Japan |
| Investigative Site JP300 | Kyoto | 602-8566 | Japan |
| Investigative Site JP301 | Nakagami-gun | 903-0215 | Japan |
| Investigative Site JP303 | Niigata | 951-8520 | Japan |
| Investigative Site JP307 | Nishinomiya-shi | 663-8186 | Japan |
| Investigative Site JP308 | Sapporo | 060-8648 | Japan |
| Investigative Site JP302 | Sendai | 980-8574 | Japan |
| Investigative Site JP309 | Shinjuku-ku | 160-0023 | Japan |
| Investigative Site JP306 | Tsukuba | 305-8576 | Japan |
| Investigative Site NL302 | Breda | 4818 CK | Netherlands |
| Investigative Site NL303 | Groningen | 9713 GZ | Netherlands |
| Investigative Site NL301 | Rotterdam | 3015 GD | Netherlands |
| Investigative Site PL304 | Ostrowiec | 27-400 | Poland |
| Investigative Site PL303 | Poznan | 60-529 | Poland |
| Investigative Site PL301 | Wroclaw | 50-566 | Poland |
| Investigative Site PL302 | Wroclaw | 51-318 | Poland |
| Investigative Site ES302 | Badalona | 08916 | Spain |
| Investigative Site ES303 | Barcelona | 08003 | Spain |
| Investigative Site ES301 | Granada | 18014 | Spain |
| Investigative Site ES305 | Madrid | 28041 | Spain |
| Investigative Site ES300 | Pontevedra | 36001 | Spain |
| Investigative Site ES304 | Santiago de Compostela | 15706 | Spain |
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| D016575 | Hidradenitis |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D013543 | Sweat Gland Diseases |
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