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

August 24, 2026 updated by: Incyte Corporation

A Phase 3, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa

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]).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

617

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Charlestown, New South Wales, Australia, 02290
        • Investigative Site AU203
      • Kogarah, New South Wales, Australia, 02217
        • Investigative Site AU205
      • Liverpool, New South Wales, Australia, 02170
        • Investigative Site AU200
    • Queensland
      • Woolloongabba, Queensland, Australia, 04102
        • Investigative Site AU206
      • Woolloongabba, Queensland, Australia, 04102
        • Investigative Site AU207
    • Victoria
      • Carlton, Victoria, Australia, 03053
        • Investigative Site AU201
      • Melbourne, Victoria, Australia, 03002
        • Investigative Site AU204
  • Austria
      • Inssbruck, Austria, 06020
        • Investigative Site AT306
      • Vienna, Austria, 01090
        • Investigative Site AT305
  • Belgium
      • Brussels, Belgium, 01070
        • Investigative Site BE300
      • Ghent, Belgium, 09000
        • Investigative Site BE301
      • Liège, Belgium, 04000
        • Investigative Site BE302
  • Bulgaria
      • Sofia, Bulgaria, 01407
        • Investigative Site BG203
      • Sofia, Bulgaria, 01463
        • Investigative Site BG202
      • Sofia, Bulgaria, 01510
        • Investigative Site BG200
      • Sofia, Bulgaria, 01606
        • Investigative Site BG204
      • Stara Zagora, Bulgaria, 06000
        • Investigative Site BG201
  • Canada
      • St. John's, Canada, A1A 4Y3
        • Investigative Site CA203
    • Alberta
      • Calgary, Alberta, Canada, T3E 0B2
        • Investigative Site CA202
      • Edmonton, Alberta, Canada, T6G 1C3
        • Investigative Site CA204
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 0C6
        • Investigative Site CA200
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3M 3Z4
        • Investigative Site CA301
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 1G9
        • Investigative Site CA205
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • Investigative Site CA304
      • Hamilton, Ontario, Canada, L8L 3C3
        • Investigative Site CA308
      • London, Ontario, Canada, N6H 5L5
        • Investigative Site CA303
      • Mississauga, Ontario, Canada, L4W 0C2
        • Investigative Site CA207
      • Peterborough, Ontario, Canada, K9J 5K2
        • Investigative Site CA302
      • Richmond Hill, Ontario, Canada, L4B 1L1
        • Investigative Site CA208
    • Quebec
      • Montreal, Quebec, Canada, H2X 2V1
        • Investigative Site CA307
      • Saint-Jérôme, Quebec, Canada, J7Z 7E2
        • Investigative Site CA206
  • Czechia
      • Ostrava - Poruba, Czechia, 708 52
        • Investigative Site CZ301
      • Prague, Czechia, 150 06
        • Investigative Site CZ300
  • Denmark
      • Roskilde, Denmark, 04000
        • Investigative Site DK201
      • Århus N, Denmark, 08200
        • Investigative Site DK200
  • France
      • Bordeaux, France, 33000
        • Investigative Site FR305
      • Brest, France, 29609
        • Investigative Site FR303
      • Dijon, France, 21000
        • Investigative Site FR205
      • Le Mans, France, 72037
        • Investigative Site FR307
      • Lyon, France, 69437
        • Investigative Site FR204
      • Marseille, France, 13385
        • Investigative Site FR304
      • Nantes, France, 44093
        • Investigative Site FR302
      • Nice, France, 06200
        • Investigative Site FR203
      • Paris, France, 75010
        • Investigative Site FR300
      • Reims, France, 51100
        • Investigative Site FR206
      • Rouen, France, 76031
        • Investigative Site FR202
      • Saint-Priest-en-Jarez, France, 42270
        • Investigative Site FR301
      • Toulouse, France, 31059
        • Investigative Site FR306
  • Germany
      • Berlin, Germany, 10117
        • Investigative Site DE202
      • Bochum, Germany, 44791
        • Investigative Site DE203
      • Darmstadt, Germany, 64283
        • Investigative Site DE305
      • Dessau, Germany, 06847
        • Investigative Site DE201
      • Dresden, Germany, 01307
        • Investigative Site DE302
      • Düsseldorf, Germany, 40225
        • Investigative Site DE306
      • Erlangen, Germany, 91054
        • Investigative Site DE207
      • Frankfurt, Germany, 60590
        • Investigative Site DE301
      • Göttingen, Germany, 37075
        • Investigative Site DE208
      • Hamburg, Germany, 20246
        • Investigative Site DE303
      • Hanover, Germany, 30159
        • Investigative Site DE300
      • Heidelberg, Germany, 69120
        • Investigative Site DE205
      • Kiel, Germany, 24105
        • Investigative Site DE200
      • Memmingen, Germany, 87700
        • Investigative Site DE307
      • Merzig, Germany, 66663
        • Investigative Site DE206
  • Greece
      • Athens, Greece, 12462
        • Investigative Site GR300
      • Athens, Greece, 16121
        • Investigative Site GR303
      • Thessaloniki, Greece, 56403
        • Investigative Site GR302
  • Italy
      • Ancona, Italy, 60126
        • Investigative Site IT200
      • Catania, Italy, 95123
        • Investigative Site IT207
      • Milan, Italy, 20122
        • Investigative Site IT202
      • Pisa, Italy, 56126
        • Investigative Site IT206
      • Roma, Italy, 00136
        • Investigative Site IT205
      • Rozzano, Italy, 20089
        • Investigative Site IT201
  • Japan
      • Ginowan-shi, Japan, 901-2725
        • Investigative Site JP301
      • Itabashi-ku, Japan, 173-8610
        • Investigative Site JP304
      • Kurume-shi, Japan, 830-0011
        • Investigative Site JP305
      • Kyoto, Japan, 602-8566
        • Investigative Site JP300
      • Niigata, Japan, 951-8520
        • Investigative Site JP303
      • Sapporo, Japan, 060-8648
        • Investigative Site JP308
      • Sendai, Japan, 980-8574
        • Investigative Site JP302
      • Shinjuku-ku, Japan, 160-0023
        • Investigative Site JP309
  • Netherlands
      • Breda, Netherlands, 4818 CK
        • Investigative Site NL302
      • Groningen, Netherlands, 9713 GZ
        • Investigative Site NL303
      • Rotterdam, Netherlands, 3015 GD
        • Investigative Site NL301
  • Poland
      • Lublin, Poland, 20573
        • Investigative Site PL203
      • Ostrowiec Świętokrzyski, Poland, 27-400
        • Investigative Site PL304
      • Rzeszów, Poland, 35-055
        • Investigative Site PL200
      • Warsaw, Poland, 02-507
        • Investigative Site PL201
      • Warsaw, Poland, 02-962
        • Investigative Site PL202
      • Wroclaw, Poland, 50-566
        • Investigative Site PL301
      • Wroclaw, Poland, 51-503
        • Investigative Site PL302
  • Spain
      • Alicante, Spain, 03010
        • Investigative Site ES203
      • Badalona, Spain, 08916
        • Investigative Site ES302
      • Barcelona, Spain, 08003
        • Investigative Site ES303
      • Granada, Spain, 18014
        • Investigative Site ES301
      • Las Palmas de Gran Canaria, Spain, 35010
        • Investigative Site ES202
      • Madrid, Spain, 28040
        • Investigative Site ES205
      • Madrid, Spain, 28041
        • Investigative Site ES305
      • Madrid, Spain, 28009
        • Investigative Site ES201
      • Manises, Spain, 46940
        • Investigative Site ES200
      • Pontevedra, Spain, 36001
        • Investigative Site ES300
      • Santiago de Compostela, Spain, 15706
        • Investigative Site ES304
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Investigative Site GB202
      • Dudley, United Kingdom, DY1 2HQ
        • Investigative Site GB200
      • Salford, United Kingdom, M6 8HD
        • Investigative Site GB203
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Investigative Site US303
      • Scottsdale, Arizona, United States, 85255
        • Investigative Site US240
    • Arkansas
      • Fort Smith, Arkansas, United States, 72916
        • Investigative Site US307
      • Rogers, Arkansas, United States, 72758
        • Investigative Site US214
    • California
      • Laguna Niguel, California, United States, 92677
        • Investigative Site US315
      • Los Angeles, California, United States, 90033
        • Investigative Site US223
      • Oakland, California, United States, 94611
        • Investigative Site US222
      • San Diego, California, United States, 92103
        • Investigative Site US226
    • Florida
      • Clearwater, Florida, United States, 33614
        • Investigative Site US309
      • Hialeah, Florida, United States, 33012-3618
        • Investigative Site US317
      • Hollywood, Florida, United States, 33021
        • Investigative Site US306
      • Hollywood, Florida, United States, 33021
        • Investigative Site US320
      • Maitland, Florida, United States, 32751
        • Investigative Site US316
      • Margate, Florida, United States, 33063
        • Investigative Site US227
      • Miami, Florida, United States, 33125
        • Investigative Site US204
      • Miami, Florida, United States, 33173
        • Investigative Site US236
      • North Miami Beach, Florida, United States, 33162-4708
        • Investigative Site US321
      • Ocala, Florida, United States, 34470
        • Investigative Site US200
      • Tampa, Florida, United States, 33613
        • Investigative Site US201
      • Tampa, Florida, United States, 33609
        • Investigative Site US228
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Investigative Site US311
    • Illinois
      • West Dundee, Illinois, United States, 60118
        • Investigative Site US220
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Investigative Site US206
      • Indianapolis, Indiana, United States, 46250
        • Investigative Site US337
    • Kentucky
      • Bowling Green, Kentucky, United States, 42104
        • Investigative Site US341
      • Louisville, Kentucky, United States, 40241
        • Investigative Site US209
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Investigative Site US305
      • Metairie, Louisiana, United States, 70006
        • Investigative Site US207
      • New Orleans, Louisiana, United States, 70115
        • Investigative Site US229
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Investigative Site US224
      • Marriottsville, Maryland, United States, 21104
        • Investigative Site US325
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Investigative Site US304
      • Boston, Massachusetts, United States, 02115
        • Investigative Site US225
      • Brighton, Massachusetts, United States, 02135
        • Investigative Site US310
      • Quincy, Massachusetts, United States, 02169
        • Investigative Site US221
    • Michigan
      • Fort Gratiot, Michigan, United States, 48059
        • Investigative Site US213
      • Waterford, Michigan, United States, 48328
        • Investigative Site US217
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Investigative Site US212
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Investigative Site US302
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Investigative Site US318
    • New Jersey
      • East Windsor, New Jersey, United States, 08520
        • Investigative Site US230
    • New York
      • Kew Gardens, New York, United States, 11415
        • Investigative Site US324
      • New York, New York, United States, 10028
        • Investigative Site US202
      • Rochester, New York, United States, 14620
        • Investigative Site US210
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27516
        • Investigative Site US205
    • Ohio
      • Bexley, Ohio, United States, 43209
        • Investigative Site US215
      • Bexley, Ohio, United States, 43209
        • Investigative Site US339
      • Boardman, Ohio, United States, 44512
        • Investigative Site US330
      • Cincinnati, Ohio, United States, 45219
        • Investigative Site US314
      • Cleveland, Ohio, United States, 44106
        • Investigative Site US312
      • Gahanna, Ohio, United States, 43230
        • Investigative Site US203
    • Oregon
      • Portland, Oregon, United States, 97201
        • Investigative Site US301
    • Tennessee
      • Murfreesboro, Tennessee, United States, 37130
        • Investigative Site US232
    • Texas
      • Arlington, Texas, United States, 76011
        • Investigative Site US235
      • Bellaire, Texas, United States, 77401
        • Investigative Site US218
      • Bellaire, Texas, United States, 77401
        • Investigative Site US340
      • Pflugerville, Texas, United States, 78660
        • Investigative Site US238
      • Plano, Texas, United States, 75025
        • Investigative Site US300
      • San Antonio, Texas, United States, 78213
        • Investigative Site US234
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Investigative Site US313
    • Washington
      • Spokane, Washington, United States, 99202
        • Investigative Site US308

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A
Povorcitinib at the protocol-defined dose strength based on cohort assignment.
Drug: Povorcitinib
Oral; Tablet
Other Names:
  • INCB054707
Experimental: Cohort B
Povorcitinib at the protocol-defined dose strength based on cohort assignment.
Drug: Povorcitinib
Oral; Tablet
Other Names:
  • INCB054707
Experimental: Cohort C
Povorcitinib at the protocol-defined dose strength based on cohort assignment.
Drug: Povorcitinib
Oral; Tablet
Other Names:
  • INCB054707

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with Treatment-Emergent Adverse Events (TEAEs)
Time Frame: up to approximately 56 weeks
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with Serious Treatment-Emergent Adverse Events (TEAEs)
Time Frame: up to approximately 56 weeks
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.
up to approximately 56 weeks
Proportion of participants with TEAEs leading to study drug discontinuation
Time Frame: up to approximately 56 weeks
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)
Time Frame: up to approximately 56 weeks
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)
Time Frame: up to approximately 56 weeks
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)
Time Frame: up to approximately 56 weeks
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)
Time Frame: up to approximately 56 weeks
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
Time Frame: up to approximately 56 weeks
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 Frame: up to approximately 56 weeks
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
Time Frame: up to approximately 56 weeks
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
Time Frame: up to approximately 56 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.
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
Time Frame: up to approximately 56 weeks
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
Time Frame: up to approximately 56 weeks
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
Time Frame: up to approximately 56 weeks
up to approximately 56 weeks
Proportion of participants with a total AN count of 0, 1, or 2 at each visit
Time Frame: up to approximately 56 weeks
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
Time Frame: up to approximately 56 weeks
ANdT count is defined as the total sum of abscesses, inflammatory nodules, and draining tunnels.
up to approximately 56 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Investigators

  • Study Director: Incyte Medical Monitor, Incyte Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2024

Primary Completion (Estimated)

December 26, 2026

Study Completion (Estimated)

December 26, 2026

Study Registration Dates

First Submitted

January 9, 2024

First Submitted That Met QC Criteria

January 9, 2024

First Posted (Actual)

January 19, 2024

Study Record Updates

Last Update Posted (Actual)

August 25, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCB 54707-312
  • 2023 (U.S. NIH Grant/Contract: GRAMMY Museum Foundation)
  • 2023-507204-31-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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