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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-507204-31-00 | Registry Identifier | EU CT Number |
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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]).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | Povorcitinib at the protocol-defined dose strength based on cohort assignment. |
|
| Cohort B | Experimental | Povorcitinib at the protocol-defined dose strength based on cohort assignment. |
|
| Cohort C | Experimental | Povorcitinib at the protocol-defined dose strength based on cohort assignment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Povorcitinib | Drug | Oral; Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with Treatment-Emergent Adverse Events (TEAEs) | 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. | up to approximately 56 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with Serious Treatment-Emergent Adverse Events (TEAEs) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Incyte Medical Monitor | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site US303 | Phoenix | Arizona | 85006 | United States | ||
| Investigative Site US240 |
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| Label | URL |
|---|---|
| A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa (STOP-HS LTE) | 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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Cohort C is open-label.
| up to approximately 56 weeks |
| Proportion of participants with TEAEs leading to study drug discontinuation | Defined as any TEAE that leads to discontinuation of study drug. | up to approximately 56 weeks |
| Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR) | 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. | up to approximately 56 weeks |
| Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) | 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. | up to approximately 56 weeks |
| Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 90 (HiSCR90) | 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. | up to approximately 56 weeks |
| Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 100 (HiSCR100) | 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. | up to approximately 56 weeks |
| Proportion of participants with flare at each visit | 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. | up to approximately 56 weeks |
| Time to first flare | Time to first flare during the long-term extension study. | up to approximately 56 weeks |
| Mean change from baseline of parent study in Hidradenitis Suppurativa Quality of Life (HiSQoL) score at each visit | 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. | up to approximately 56 weeks |
| Mean change from baseline of parent study 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. | up to approximately 56 weeks |
| 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 abscess, inflammatory nodule, and draining tunnel (ANdT) count relative to Week 54 at each visit | ANdT count is defined as the total sum of abscesses, inflammatory nodules, and draining tunnels. | 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 | AN count defined as the total sum of abscesses and inflammatory nodules. | up to approximately 56 weeks |
| Proportion of participants with a total ANdT count of 0, 1, or 2 at each visit | ANdT count is defined as the total sum of abscesses, inflammatory nodules, and draining tunnels. | up to approximately 56 weeks |
| Scottsdale |
| Arizona |
| 85255 |
| United States |
| Investigative Site US307 | Fort Smith | Arkansas | 72916 | United States |
| Investigative Site US214 | Rogers | Arkansas | 72758 | United States |
| Investigative Site US315 | Laguna Niguel | California | 92677 | United States |
| Investigative Site US223 | Los Angeles | California | 90033 | United States |
| Investigative Site US222 | Oakland | California | 94611 | United States |
| Investigative Site US226 | San Diego | California | 92103 | United States |
| Investigative Site US309 | Clearwater | Florida | 33614 | United States |
| Investigative Site US317 | Hialeah | Florida | 33012-3618 | United States |
| Investigative Site US306 | Hollywood | Florida | 33021 | United States |
| Investigative Site US320 | Hollywood | Florida | 33021 | United States |
| Investigative Site US316 | Maitland | Florida | 32751 | 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 US321 | North Miami Beach | Florida | 33162-4708 | United States |
| Investigative Site US200 | Ocala | Florida | 34470 | United States |
| Investigative Site US228 | Tampa | Florida | 33609 | United States |
| Investigative Site US201 | Tampa | Florida | 33613 | United States |
| Investigative Site US311 | Marietta | Georgia | 30060 | United States |
| Investigative Site US220 | West Dundee | Illinois | 60118 | United States |
| Investigative Site US206 | Indianapolis | Indiana | 46250 | United States |
| Investigative Site US337 | Indianapolis | Indiana | 46250 | United States |
| Investigative Site US341 | Bowling Green | Kentucky | 42104 | United States |
| Investigative Site US209 | Louisville | Kentucky | 40241 | United States |
| Investigative Site US305 | Baton Rouge | Louisiana | 70809 | United States |
| Investigative Site US207 | Metairie | Louisiana | 70006 | United States |
| Investigative Site US229 | New Orleans | Louisiana | 70115 | United States |
| Investigative Site US224 | Baltimore | Maryland | 21287 | United States |
| Investigative Site US325 | Marriottsville | Maryland | 21104 | United States |
| Investigative Site US225 | Boston | Massachusetts | 02115 | United States |
| Investigative Site US304 | Boston | Massachusetts | 02215 | United States |
| Investigative Site US310 | Brighton | Massachusetts | 02135 | United States |
| Investigative Site US221 | Quincy | Massachusetts | 02169 | United States |
| Investigative Site US213 | Fort Gratiot | Michigan | 48059 | United States |
| Investigative Site US217 | Waterford | Michigan | 48328 | United States |
| Investigative Site US212 | Minneapolis | Minnesota | 55455 | United States |
| Investigative Site US302 | St Louis | Missouri | 63110 | United States |
| Investigative Site US318 | Portsmouth | New Hampshire | 03801 | United States |
| Investigative Site US230 | East Windsor | New Jersey | 08520 | United States |
| Investigative Site US324 | Kew Gardens | New York | 11415 | United States |
| Investigative Site US202 | New York | New York | 10028 | United States |
| Investigative Site US210 | Rochester | New York | 14620 | United States |
| Investigative Site US205 | Chapel Hill | North Carolina | 27516 | United States |
| Investigative Site US215 | Bexley | Ohio | 43209 | 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 US203 | Gahanna | Ohio | 43230 | United States |
| Investigative Site US301 | Portland | Oregon | 97201 | 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 US340 | Bellaire | Texas | 77401 | United States |
| Investigative Site US238 | Pflugerville | Texas | 78660 | United States |
| Investigative Site US300 | Plano | Texas | 75025 | United States |
| Investigative Site US234 | San Antonio | Texas | 78213 | United States |
| Investigative Site US313 | Norfolk | Virginia | 23502 | United States |
| Investigative Site US308 | Spokane | Washington | 99202 | United States |
| Investigative Site AU203 | Charlestown | New South Wales | 02290 | Australia |
| Investigative Site AU205 | Kogarah | New South Wales | 02217 | Australia |
| Investigative Site AU200 | Liverpool | New South Wales | 02170 | 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 AT306 | Inssbruck | 06020 | Austria |
| Investigative Site AT305 | Vienna | 01090 | Austria |
| Investigative Site BE300 | Brussels | 01070 | Belgium |
| Investigative Site BE301 | Ghent | 09000 | Belgium |
| Investigative Site BE302 | Liège | 04000 | Belgium |
| 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 CA301 | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| Investigative Site CA205 | Fredericton | New Brunswick | E3B 1G9 | Canada |
| Investigative Site CA304 | Barrie | Ontario | L4M 7G1 | Canada |
| Investigative Site CA308 | Hamilton | Ontario | L8L 3C3 | Canada |
| Investigative Site CA303 | London | Ontario | N6H 5L5 | Canada |
| Investigative Site CA207 | Mississauga | Ontario | L4W 0C2 | Canada |
| Investigative Site CA302 | Peterborough | Ontario | K9J 5K2 | Canada |
| Investigative Site CA208 | Richmond Hill | Ontario | L4B 1L1 | Canada |
| Investigative Site CA307 | Montreal | Quebec | H2X 2V1 | Canada |
| Investigative Site CA206 | Saint-Jérôme | Quebec | J7Z 7E2 | Canada |
| Investigative Site CA203 | St. John's | A1A 4Y3 | Canada |
| Investigative Site CZ301 | Ostrava - Poruba | 708 52 | Czechia |
| Investigative Site CZ300 | Prague | 150 06 | Czechia |
| Investigative Site DK200 | Århus N | 08200 | Denmark |
| Investigative Site DK201 | Roskilde | 04000 | Denmark |
| Investigative Site FR305 | Bordeaux | 33000 | France |
| Investigative Site FR303 | Brest | 29609 | France |
| Investigative Site FR205 | Dijon | 21000 | France |
| Investigative Site FR307 | Le Mans | 72037 | France |
| Investigative Site FR204 | Lyon | 69437 | France |
| Investigative Site FR304 | Marseille | 13385 | France |
| Investigative Site FR302 | Nantes | 44093 | France |
| Investigative Site FR203 | Nice | 06200 | France |
| Investigative Site FR300 | Paris | 75010 | France |
| Investigative Site FR206 | Reims | 51100 | France |
| Investigative Site FR202 | Rouen | 76031 | France |
| Investigative Site FR301 | Saint-Priest-en-Jarez | 42270 | France |
| Investigative Site FR306 | Toulouse | 31059 | France |
| Investigative Site DE202 | Berlin | 10117 | Germany |
| Investigative Site DE203 | Bochum | 44791 | Germany |
| Investigative Site DE305 | Darmstadt | 64283 | Germany |
| Investigative Site DE201 | Dessau | 06847 | Germany |
| Investigative Site DE302 | Dresden | 01307 | Germany |
| Investigative Site DE306 | Düsseldorf | 40225 | Germany |
| Investigative Site DE207 | Erlangen | 91054 | Germany |
| Investigative Site DE301 | Frankfurt | 60590 | Germany |
| Investigative Site DE208 | Göttingen | 37075 | Germany |
| Investigative Site DE303 | Hamburg | 20246 | Germany |
| Investigative Site DE300 | Hanover | 30159 | Germany |
| Investigative Site DE205 | Heidelberg | 69120 | Germany |
| Investigative Site DE200 | Kiel | 24105 | Germany |
| Investigative Site DE307 | Memmingen | 87700 | Germany |
| Investigative Site DE206 | Merzig | 66663 | Germany |
| Investigative Site GR300 | Athens | 12462 | Greece |
| Investigative Site GR303 | Athens | 16121 | Greece |
| Investigative Site GR302 | Thessaloniki | 56403 | Greece |
| Investigative Site IT200 | Ancona | 60126 | Italy |
| Investigative Site IT207 | Catania | 95123 | Italy |
| Investigative Site IT202 | Milan | 20122 | Italy |
| Investigative Site IT206 | Pisa | 56126 | Italy |
| Investigative Site IT205 | Roma | 00136 | Italy |
| Investigative Site IT201 | Rozzano | 20089 | Italy |
| Investigative Site JP301 | Ginowan-shi | 901-2725 | Japan |
| 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 JP303 | Niigata | 951-8520 | 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 NL302 | Breda | 4818 CK | Netherlands |
| Investigative Site NL303 | Groningen | 9713 GZ | Netherlands |
| Investigative Site NL301 | Rotterdam | 3015 GD | Netherlands |
| Investigative Site PL203 | Lublin | 20573 | Poland |
| Investigative Site PL304 | Ostrowiec Świętokrzyski | 27-400 | Poland |
| Investigative Site PL200 | Rzeszów | 35-055 | Poland |
| Investigative Site PL201 | Warsaw | 02-507 | Poland |
| Investigative Site PL202 | Warsaw | 02-962 | Poland |
| Investigative Site PL301 | Wroclaw | 50-566 | Poland |
| Investigative Site PL302 | Wroclaw | 51-503 | Poland |
| Investigative Site ES203 | Alicante | 03010 | Spain |
| Investigative Site ES302 | Badalona | 08916 | Spain |
| Investigative Site ES303 | Barcelona | 08003 | Spain |
| Investigative Site ES301 | Granada | 18014 | Spain |
| Investigative Site ES202 | Las Palmas de Gran Canaria | 35010 | Spain |
| Investigative Site ES201 | Madrid | 28009 | Spain |
| Investigative Site ES205 | Madrid | 28040 | Spain |
| Investigative Site ES305 | Madrid | 28041 | Spain |
| Investigative Site ES200 | Manises | 46940 | Spain |
| Investigative Site ES300 | Pontevedra | 36001 | Spain |
| Investigative Site ES304 | Santiago de Compostela | 15706 | Spain |
| Investigative Site GB202 | Birmingham | B15 2TH | United Kingdom |
| Investigative Site GB200 | Dudley | DY1 2HQ | 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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