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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-501753-36-00 | 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 US240 | Scottsdale | Arizona | 85255 | United States | ||
| Investigative Site US237 |
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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 (HS) | 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 at Week 12 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 | 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 | Defined as mean change of abscess(es) count relative to baseline. | 54 weeks |
| Percentage change from baseline in abscess count | Percent Change from baseline in number of abscess(es) | 54 weeks |
| Mean change from baseline in inflammatory nodule count | Defined as mean change of inflammatory nodule count relative to baseline. | 54 weeks |
| Percentage change from baseline in inflammatory nodule count | Defined as percent change from baseline in number of inflammatory nodule(s) | 54 weeks |
| Mean change from baseline in draining tunnel count | Defined as mean change of draining tunnel count relative to baseline. | 54 weeks |
| Percentage change from baseline in draining tunnel count | 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 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 |
| Scottsdale |
| Arizona |
| 85259 |
| United States |
| Investigative Site US214 | Arkansas City | Arkansas | 72758 | United States |
| Investigative Site US242 | Fayetteville | Arkansas | 72703 | United States |
| Investigative Site US223 | Los Angeles | California | 90033 | United States |
| Investigative Site US226 | San Diego | California | 92103 | United States |
| Investigative Site US222 | San Francisco | California | 94118 | United States |
| Investigative Site US233 | Washington D.C. | District of Columbia | 20060 | United States |
| Investigative Site US228 | Brandon | Florida | 33511 | United States |
| Investigative Site US227 | Margate | Florida | 33063 | United States |
| Investigative Site US204 | Miami | Florida | 33125 | United States |
| Investigative Site US236 | Miami | Florida | 33173 | United States |
| Investigative Site US200 | Ocala | Florida | 34470 | United States |
| Investigative Site US201 | Tampa | Florida | 33613 | United States |
| Investigative Site US220 | West Dundee | Illinois | 60118 | United States |
| Investigative Site US206 | Indianapolis | Indiana | 46250 | United States |
| Investigative Site US241 | Iowa City | Iowa | 52242 | United States |
| Investigative Site US209 | Louisville | Kentucky | 40241 | United States |
| Investigative Site US207 | Metairie | Louisiana | 70006 | United States |
| Investigative Site US229 | New Orleans | Louisiana | 70115 | United States |
| Investigative Site US224 | Baltimore | Maryland | 21224 | United States |
| Investigative Site US208 | Beverly | Massachusetts | 01915 | United States |
| Investigative Site US221 | Quincy | Massachusetts | 02169 | United States |
| Investigative Site US213 | Detroit | Michigan | 48084 | United States |
| Investigative Site US217 | Waterford | Michigan | 48328 | United States |
| Investigative Site US212 | Minneapolis | Minnesota | 55455 | United States |
| Investigative Site US239 | Omaha | Nebraska | 68144 | United States |
| Investigative Site US230 | Hightstown | New Jersey | 08520 | United States |
| Investigative Site US202 | New York | New York | 10003 | United States |
| Investigative Site US210 | Rochester | New York | 14642 | United States |
| Investigative Site US205 | Chapel Hill | North Carolina | 27516 | United States |
| Investigative Site US215 | Bexley | Ohio | 43209 | United States |
| Investigative Site US203 | Columbus | Ohio | 43210 | United States |
| Investigative Site US232 | Murfreesboro | Tennessee | 37130 | United States |
| Investigative Site US235 | Arlington | Texas | 76011 | United States |
| Investigative Site US218 | Bellaire | Texas | 77401 | United States |
| Investigative Site US238 | Pflugerville | Texas | 78660 | United States |
| Investigative Site US234 | San Antonio | Texas | 78213 | United States |
| Investigative Site AU205 | Kogarah | New South Wales | 02217 | Australia |
| Investigative Site AU203 | Kotara | New South Wales | 02289 | Australia |
| Investigative Site AU200 | Liverpool | New South Wales | 02170 | Australia |
| Investigative Site AU202 | Benowa | Queensland | 04217 | Australia |
| Investigative Site AU206 | Woolloongabba | Queensland | 04102 | Australia |
| Investigative Site AU207 | Woolloongabba | Queensland | 04102 | Australia |
| Investigative Site AU201 | Carlton | Victoria | 03053 | Australia |
| Investigative Site AU204 | Melbourne | Victoria | 03002 | Australia |
| Investigative Site BG203 | Sofia | 01407 | Bulgaria |
| Investigative Site BG202 | Sofia | 01463 | Bulgaria |
| Investigative Site BG200 | Sofia | 01510 | Bulgaria |
| Investigative Site BG204 | Sofia | 01606 | Bulgaria |
| Investigative Site BG201 | Stara Zagora | 06000 | Bulgaria |
| Investigative Site CA202 | Calgary | Alberta | T3E 0B2 | Canada |
| Investigative Site CA204 | Edmonton | Alberta | T6G 1C3 | Canada |
| Investigative Site CA200 | Surrey | British Columbia | V3V 0C6 | Canada |
| Investigative Site CA205 | Fredericton | New Brunswick | E3B 1G9 | Canada |
| Investigative Site CA207 | Mississauga | Ontario | L4W 0C2 | Canada |
| Investigative Site CA208 | Richmond Hill | Ontario | L4C 9M7 | Canada |
| Investigative Site CA206 | Saint-Jérôme | Quebec | J7Z 7E2 | Canada |
| Investigative Site CA203 | St. John's | A1A 4Y3 | Canada |
| Investigative Site DK200 | Århus N | 08200 | Denmark |
| Investigative Site DK201 | Roskilde | 04000 | Denmark |
| Investigative Site FR200 | Antony | 92160 | France |
| Investigative Site FR205 | Dijon | 21000 | France |
| Investigative Site FR204 | Lyon | 69003 | France |
| Investigative Site FR203 | Nice | 06200 | France |
| Investigative Site FR206 | Reims | 51100 | France |
| Investigative Site FR202 | Rouen | 76031 | France |
| Investigative Site FR201 | Toulon | 83000 | France |
| Investigative Site US225 | Frankfurt am Main | MA | 60590 | Germany |
| Investigative Site DE202 | Berlin | 10117 | Germany |
| Investigative Site DE203 | Bochum | 44791 | Germany |
| Investigative Site DE201 | Dessau | 06847 | Germany |
| Investigative Site DE207 | Erlangen | 91054 | Germany |
| Investigative Site DE208 | Göttingen | 37075 | Germany |
| Investigative Site DE205 | Heidelberg | 69120 | Germany |
| Investigative Site DE200 | Kiel | 24105 | Germany |
| Investigative Site DE204 | Lübeck | 23538 | Germany |
| Investigative Site DE206 | Mainz | 55131 | Germany |
| Investigative Site IT200 | Ancona | 60126 | Italy |
| Investigative Site IT204 | Brescia | 25124 | Italy |
| Investigative Site IT207 | Catania | 95123 | Italy |
| Investigative Site IT202 | Milan | 20122 | Italy |
| Investigative Site IT203 | Naples | 80131 | Italy |
| Investigative Site IT206 | Pisa | 56126 | Italy |
| Investigative Site IT205 | Roma | 00168 | Italy |
| Investigative Site IT201 | Rozzano | 20089 | Italy |
| Investigative Site PL203 | Lublin | 20573 | Poland |
| Investigative Site PL200 | Rzeszów | 35-055 | Poland |
| Investigative Site PL201 | Warsaw | 02-507 | Poland |
| Investigative Site PL202 | Warsaw | 02-962 | Poland |
| Investigative Site ES203 | Alicante | 03010 | Spain |
| Investigative Site ES202 | Las Palmas de Gran Canaria | 35019 | Spain |
| Investigative Site ES204 | Madrid | 28005 | Spain |
| Investigative Site ES201 | Madrid | 28007 | Spain |
| Investigative Site ES205 | Madrid | 28040 | Spain |
| Investigative Site ES200 | Manises | 46940 | Spain |
| Investigative Site GB202 | Birmingham | B15 2GW | United Kingdom |
| Investigative Site GB200 | Dudley | DY1 2HQ | United Kingdom |
| Investigative Site GB201 | Leeds | LS1 3EX | United Kingdom |
| Investigative Site GB204 | London | SE1 7EH | United Kingdom |
| Investigative Site GB203 | Salford | M6 8HD | United Kingdom |
| 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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