A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified February 2026 by Incyte Corporation
Sponsor
Incyte Corporation
Information Provided by (Responsible Party)
Incyte Corporation
Clinicaltrials.gov Identifier
NCT06212999
Other Study ID Numbers:
INCB 54707-312
First Submitted
January 8, 2024
First Posted
January 18, 2024
Last Update Posted
March 22, 2026
Last Verified
February 2026

ClinicalTrials.gov processed this data on March 2026Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Hidradenitis Suppurativa (HS)
Drug: PovorcitinibDrug: PovorcitinibDrug: Povorcitinib

Study Design

Study TypeInterventional
Actual Enrollment617 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA Phase 3, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa
Study Start DateJanuary 29, 2024
Actual Primary Completion Date7mos 3d from now
Actual Study Completion Date7mos 3d from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Cohort A
Povorcitinib at the protocol-defined dose strength based on cohort assignment.
Drug: Povorcitinib
Oral; Tablet
Cohort B
Povorcitinib at the protocol-defined dose strength based on cohort assignment.
Drug: Povorcitinib
Oral; Tablet
Cohort C
Povorcitinib at the protocol-defined dose strength based on cohort assignment.
Drug: Povorcitinib
Oral; Tablet

Outcome Measures

Primary Outcome Measures
  1. 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.
Secondary Outcome Measures
  1. 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.
  2. Proportion of participants with TEAEs leading to study drug discontinuation
    Defined as any TEAE that leads to discontinuation of study drug.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. Time to first flare
    Time to first flare during the long-term extension study.
  9. 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.
  10. 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.
  11. Proportion of participants with no increase in abscess and inflammatory nodule (AN) count relative to Week 54 at each visit
  12. 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.
  13. Proportion of participants with no increase in draining tunnel count relative to Week 54 at each visit
  14. 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.
  15. 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.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Completion of the study treatment period of the originating parent study (INCB 54707-301 or INCB 54707-302).
Agreement to use contraception.
Willing and able to comply with the study protocol and procedures.
Further inclusion criteria apply.
Exclusion Criteria
Participation in the extension study could expose the participant to an undue safety risk.
Women who are pregnant (or who are considering pregnancy) or breastfeeding.
Further exclusion criteria apply.

Contacts and Locations

Sponsors and CollaboratorsIncyte Corporation
Locations
Investigative Site US303 | Phoenix Arizona, United States, 85006Investigative Site US240 | Scottsdale Arizona, United States, 85255Investigative Site US307 | Fort Smith Arkansas, United States, 72916Investigative Site US214 | Rogers Arkansas, United States, 72758Investigative Site US315 | Laguna Niguel California, United States, 92677Investigative Site US223 | Los Angeles California, United States, 90033Investigative Site US222 | Oakland California, United States, 94611Investigative Site US226 | San Diego California, United States, 92103Investigative Site US309 | Clearwater Florida, United States, 33614Investigative Site US317 | Hialeah Florida, United States, 33012-3618Investigative Site US306 | Hollywood Florida, United States, 33021Investigative Site US320 | Hollywood Florida, United States, 33021Investigative Site US316 | Maitland Florida, United States, 32751Investigative Site US227 | Margate Florida, United States, 33063Investigative Site US204 | Miami Florida, United States, 33125Investigative Site US236 | Miami Florida, United States, 33173Investigative Site US321 | North Miami Beach Florida, United States, 33162-4708Investigative Site US200 | Ocala Florida, United States, 34470Investigative Site US228 | Tampa Florida, United States, 33609Investigative Site US201 | Tampa Florida, United States, 33613Investigative Site US311 | Marietta Georgia, United States, 30060Investigative Site US220 | West Dundee Illinois, United States, 60118Investigative Site US206 | Indianapolis Indiana, United States, 46250Investigative Site US337 | Indianapolis Indiana, United States, 46250Investigative Site US341 | Bowling Green Kentucky, United States, 42104Investigative Site US209 | Louisville Kentucky, United States, 40241Investigative Site US305 | Baton Rouge Louisiana, United States, 70809Investigative Site US207 | Metairie Louisiana, United States, 70006Investigative Site US229 | New Orleans Louisiana, United States, 70115Investigative Site US224 | Baltimore Maryland, United States, 21287Investigative Site US325 | Marriottsville Maryland, United States, 21104Investigative Site US225 | Boston Massachusetts, United States, 02115Investigative Site US304 | Boston Massachusetts, United States, 02215Investigative Site US310 | Brighton Massachusetts, United States, 02135Investigative Site US221 | Quincy Massachusetts, United States, 02169Investigative Site US213 | Fort Gratiot Michigan, United States, 48059Investigative Site US217 | Waterford Michigan, United States, 48328Investigative Site US212 | Minneapolis Minnesota, United States, 55455Investigative Site US302 | St Louis Missouri, United States, 63110Investigative Site US318 | Portsmouth New Hampshire, United States, 03801Investigative Site US230 | East Windsor New Jersey, United States, 08520Investigative Site US324 | Kew Gardens New York, United States, 11415Investigative Site US202 | New York New York, United States, 10028Investigative Site US210 | Rochester New York, United States, 14620Investigative Site US205 | Chapel Hill North Carolina, United States, 27516Investigative Site US215 | Bexley Ohio, United States, 43209Investigative Site US339 | Bexley Ohio, United States, 43209Investigative Site US330 | Boardman Ohio, United States, 44512Investigative Site US314 | Cincinnati Ohio, United States, 45219Investigative Site US312 | Cleveland Ohio, United States, 44106Investigative Site US203 | Gahanna Ohio, United States, 43230Investigative Site US301 | Portland Oregon, United States, 97201Investigative Site US232 | Murfreesboro Tennessee, United States, 37130Investigative Site US235 | Arlington Texas, United States, 76011Investigative Site US218 | Bellaire Texas, United States, 77401Investigative Site US340 | Bellaire Texas, United States, 77401Investigative Site US238 | Pflugerville Texas, United States, 78660Investigative Site US300 | Plano Texas, United States, 75025Investigative Site US234 | San Antonio Texas, United States, 78213Investigative Site US313 | Norfolk Virginia, United States, 23502Investigative Site US308 | Spokane Washington, United States, 99202Investigative Site AU203 | Charlestown New South Wales, Australia, 02290Investigative Site AU205 | Kogarah New South Wales, Australia, 02217Investigative Site AU200 | Liverpool New South Wales, Australia, 02170Investigative Site AU206 | Woolloongabba Queensland, Australia, 04102Investigative Site AU207 | Woolloongabba Queensland, Australia, 04102Investigative Site AU201 | Carlton Victoria, Australia, 03053Investigative Site AU204 | Melbourne Victoria, Australia, 03002Investigative Site AT306 | Inssbruck , Austria, 06020Investigative Site AT305 | Vienna , Austria, 01090Investigative Site BE300 | Brussels , Belgium, 01070Investigative Site BE301 | Ghent , Belgium, 09000Investigative Site BE302 | Liège , Belgium, 04000Investigative Site BG203 | Sofia , Bulgaria, 01407Investigative Site BG202 | Sofia , Bulgaria, 01463Investigative Site BG200 | Sofia , Bulgaria, 01510Investigative Site BG204 | Sofia , Bulgaria, 01606Investigative Site BG201 | Stara Zagora , Bulgaria, 06000Investigative Site CA202 | Calgary Alberta, Canada, T3E 0B2Investigative Site CA204 | Edmonton Alberta, Canada, T6G 1C3Investigative Site CA200 | Surrey British Columbia, Canada, V3V 0C6Investigative Site CA301 | Winnipeg Manitoba, Canada, R3M 3Z4Investigative Site CA205 | Fredericton New Brunswick, Canada, E3B 1G9Investigative Site CA304 | Barrie Ontario, Canada, L4M 7G1Investigative Site CA308 | Hamilton Ontario, Canada, L8L 3C3Investigative Site CA303 | London Ontario, Canada, N6H 5L5Investigative Site CA207 | Mississauga Ontario, Canada, L4W 0C2Investigative Site CA302 | Peterborough Ontario, Canada, K9J 5K2Investigative Site CA208 | Richmond Hill Ontario, Canada, L4B 1L1Investigative Site CA307 | Montreal Quebec, Canada, H2X 2V1Investigative Site CA206 | Saint-Jérôme Quebec, Canada, J7Z 7E2Investigative Site CA203 | St. John's , Canada, A1A 4Y3Investigative Site CZ301 | Ostrava - Poruba , Czechia, 708 52Investigative Site CZ300 | Prague , Czechia, 150 06Investigative Site DK200 | Århus N , Denmark, 08200Investigative Site DK201 | Roskilde , Denmark, 04000Investigative Site FR305 | Bordeaux , France, 33000Investigative Site FR303 | Brest , France, 29609Investigative Site FR205 | Dijon , France, 21000Investigative Site FR307 | Le Mans , France, 72037Investigative Site FR204 | Lyon , France, 69437Investigative Site FR304 | Marseille , France, 13385Investigative Site FR302 | Nantes , France, 44093Investigative Site FR203 | Nice , France, 06200Investigative Site FR300 | Paris , France, 75010Investigative Site FR206 | Reims , France, 51100Investigative Site FR202 | Rouen , France, 76031Investigative Site FR301 | Saint-Priest-en-Jarez , France, 42270Investigative Site FR306 | Toulouse , France, 31059Investigative Site DE202 | Berlin , Germany, 10117Investigative Site DE203 | Bochum , Germany, 44791Investigative Site DE305 | Darmstadt , Germany, 64283Investigative Site DE201 | Dessau , Germany, 06847Investigative Site DE302 | Dresden , Germany, 01307Investigative Site DE306 | Düsseldorf , Germany, 40225Investigative Site DE207 | Erlangen , Germany, 91054Investigative Site DE301 | Frankfurt , Germany, 60590Investigative Site DE208 | Göttingen , Germany, 37075Investigative Site DE303 | Hamburg , Germany, 20246Investigative Site DE300 | Hanover , Germany, 30159Investigative Site DE205 | Heidelberg , Germany, 69120Investigative Site DE200 | Kiel , Germany, 24105Investigative Site DE307 | Memmingen , Germany, 87700Investigative Site DE206 | Merzig , Germany, 66663Investigative Site GR300 | Athens , Greece, 12462Investigative Site GR303 | Athens , Greece, 16121Investigative Site GR302 | Thessaloniki , Greece, 56403Investigative Site IT200 | Ancona , Italy, 60126Investigative Site IT207 | Catania , Italy, 95123Investigative Site IT202 | Milan , Italy, 20122Investigative Site IT206 | Pisa , Italy, 56126Investigative Site IT205 | Roma , Italy, 00136Investigative Site IT201 | Rozzano , Italy, 20089Investigative Site JP301 | Ginowan-shi , Japan, 901-2725Investigative Site JP304 | Itabashi-ku , Japan, 173-8610Investigative Site JP305 | Kurume-shi , Japan, 830-0011Investigative Site JP300 | Kyoto , Japan, 602-8566Investigative Site JP303 | Niigata , Japan, 951-8520Investigative Site JP308 | Sapporo , Japan, 060-8648Investigative Site JP302 | Sendai , Japan, 980-8574Investigative Site JP309 | Shinjuku-ku , Japan, 160-0023Investigative Site NL302 | Breda , Netherlands, 4818 CKInvestigative Site NL303 | Groningen , Netherlands, 9713 GZInvestigative Site NL301 | Rotterdam , Netherlands, 3015 GDInvestigative Site PL203 | Lublin , Poland, 20573Investigative Site PL304 | Ostrowiec Świętokrzyski , Poland, 27-400Investigative Site PL200 | Rzeszów , Poland, 35-055Investigative Site PL201 | Warsaw , Poland, 02-507Investigative Site PL202 | Warsaw , Poland, 02-962Investigative Site PL301 | Wroclaw , Poland, 50-566Investigative Site PL302 | Wroclaw , Poland, 51-503Investigative Site ES203 | Alicante , Spain, 03010Investigative Site ES302 | Badalona , Spain, 08916Investigative Site ES303 | Barcelona , Spain, 08003Investigative Site ES301 | Granada , Spain, 18014Investigative Site ES202 | Las Palmas de Gran Canaria , Spain, 35010Investigative Site ES201 | Madrid , Spain, 28009Investigative Site ES205 | Madrid , Spain, 28040Investigative Site ES305 | Madrid , Spain, 28041Investigative Site ES200 | Manises , Spain, 46940Investigative Site ES300 | Pontevedra , Spain, 36001Investigative Site ES304 | Santiago de Compostela , Spain, 15706Investigative Site GB202 | Birmingham , United Kingdom, B15 2THInvestigative Site GB200 | Dudley , United Kingdom, DY1 2HQInvestigative Site GB203 | Salford , United Kingdom, M6 8HD
Investigators
Study Director: Incyte Medical Monitor, Incyte Corporation