A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa (HS) (STOP-HS2)

A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa

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.

Study Overview

• Status: Recruiting
• Conditions: Hidradenitis Suppurativa (HS)
• Intervention / Treatment: Drug: Povorcitinib; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Incyte Corporation Call Center (US); Phone Number: 1.855.463.3463; Email: medinfo@incyte.com
• Study Contact Backup: Name: Incyte Corporation Call Center (ex-US); Phone Number: +800 00027423; Email: eumedinfo@incyte.com

Study Locations

• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 02217
      • Recruiting
      • Investigative Site AU205
    • Kotara, New South Wales, Australia, 02289
      • Recruiting
      • Investigative Site AU203
    • Liverpool, New South Wales, Australia, 02170
      • Recruiting
      • Investigative Site AU200
  • Queensland
    • Benowa, Queensland, Australia, 04217
      • Recruiting
      • Investigative Site AU202
    • Woolloongabba, Queensland, Australia, 04102
      • Recruiting
      • Investigative Site AU207
    • Woolloongabba, Queensland, Australia, 04102
      • Recruiting
      • Investigative Site AU206
  • Victoria
    • Carlton, Victoria, Australia, 03053
      • Recruiting
      • Investigative Site AU201
    • Melbourne, Victoria, Australia, 03002
      • Recruiting
      • Investigative Site AU204
• Bulgaria
  • Sofia, Bulgaria, 01510
    • Recruiting
    • Investigative Site BG200
  • Sofia, Bulgaria, 01463
    • Recruiting
    • Investigative Site BG202
  • Sofia, Bulgaria, 01407
    • Recruiting
    • Investigative Site BG203
  • Sofia, Bulgaria, 01606
    • Recruiting
    • Investigative Site BG204
  • Stara Zagora, Bulgaria, 06000
    • Recruiting
    • Investigative Site BG201
• Canada
  • Quebec, Canada, G1V 4T3
    • Not yet recruiting
    • Investigative Site CA209
  • St. John's, Canada, A1A 4Y3
    • Recruiting
    • Investigative Site CA203
  • Alberta
    • Calgary, Alberta, Canada, T3E 0B2
      • Recruiting
      • Investigative Site CA202
    • Edmonton, Alberta, Canada, T6G 1C3
      • Recruiting
      • Investigative Site CA204
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 0C6
      • Recruiting
      • Investigative Site CA200
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 1G9
      • Recruiting
      • Investigative Site CA205
  • Ontario
    • Mississauga, Ontario, Canada, L4W 0C2
      • Recruiting
      • Investigative Site CA207
    • Richmond Hill, Ontario, Canada, L4C 9M7
      • Not yet recruiting
      • Investigative Site CA208
  • Quebec
    • St-jérôme, Quebec, Canada, J7Z 7E2
      • Recruiting
      • Investigative Site CA206
• Denmark
  • Roskilde, Denmark, 04000
    • Recruiting
    • Investigative Site DK201
  • Århus N, Denmark, 08200
    • Recruiting
    • Investigative Site DK200
• France
  • Antony, France, 92160
    • Recruiting
    • Investigative Site FR200
  • Dijon, France, 21000
    • Recruiting
    • Investigative Site FR205
  • Lyon, France, 69003
    • Recruiting
    • Investigative Site FR204
  • Nice Cedex 3, France, 06200
    • Recruiting
    • Investigative Site FR203
  • Reims, France, 51100
    • Recruiting
    • Investigative Site FR206
  • Rouen Cedex, France, 76031
    • Recruiting
    • Investigative Site FR202
  • Toulon, France, 83000
    • Recruiting
    • Investigative Site FR201
• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Investigative Site DE202
  • Bochum, Germany, 44791
    • Recruiting
    • Investigative Site DE203
  • Dessau, Germany, 06847
    • Recruiting
    • Investigative Site DE201
  • Erlangen, Germany, 91054
    • Recruiting
    • Investigative Site DE207
  • Gottingen, Germany, 37075
    • Recruiting
    • Investigative Site DE208
  • Heidelberg, Germany, 69120
    • Recruiting
    • Investigative Site DE205
  • Kiel, Germany, 24105
    • Recruiting
    • Investigative Site DE200
  • Luebeck, Germany, 23538
    • Recruiting
    • Investigative Site DE204
  • Mainz, Germany, 55131
    • Recruiting
    • Investigative Site DE206
  • MA
    • Frankfurt Am Main, MA, Germany, 60590
      • Recruiting
      • Investigative Site US225
• Italy
  • Ancona, Italy, 60126
    • Recruiting
    • Investigative Site IT200
  • Brescia, Italy, 25124
    • Recruiting
    • Investigative Site IT204
  • Catania, Italy, 95123
    • Recruiting
    • Investigative Site IT207
  • Milano, Italy, 20122
    • Recruiting
    • Investigative Site IT202
  • Napoli, Italy, 80131
    • Recruiting
    • Investigative Site IT203
  • Pisa, Italy, 56126
    • Recruiting
    • Investigative Site IT206
  • Roma, Italy, 00168
    • Recruiting
    • Investigative Site IT205
  • Rozzano, Italy, 20089
    • Recruiting
    • Investigative Site IT201
• Poland
  • Lublin, Poland, 20573
    • Recruiting
    • Investigative Site PL203
  • Rzeszow, Poland, 35-055
    • Recruiting
    • Investigative Site PL200
  • Warszawa, Poland, 02-962
    • Recruiting
    • Investigative Site PL202
  • Warszawa, Poland, 02-807
    • Recruiting
    • Investigative Site PL201
• Spain
  • Alicante, Spain, 03010
    • Recruiting
    • Investigative Site ES203
  • Las Palmas de Gran Canaria, Spain, 35019
    • Recruiting
    • Investigative Site ES202
  • Madrid, Spain, 28005
    • Recruiting
    • Investigative Site ES204
  • Madrid, Spain, 28040
    • Recruiting
    • Investigative Site ES205
  • Madrid, Spain, 28007
    • Recruiting
    • Investigative Site ES201
  • Manises, Spain, 46940
    • Recruiting
    • Investigative Site ES200
• United Kingdom
  • Birmingham, United Kingdom, B15 2GW
    • Recruiting
    • Investigative Site GB202
  • Dudley, United Kingdom, DY1 2HQ
    • Recruiting
    • Investigative Site GB200
  • Leeds, United Kingdom, LS1 3EX
    • Recruiting
    • Investigative Site GB201
  • London, United Kingdom, SE1 7EH
    • Recruiting
    • Investigative Site GB204
  • Salford, United Kingdom, M6 8HD
    • Recruiting
    • Investigative Site GB203
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Not yet recruiting
      • Investigative Site US237
    • Scottsdale, Arizona, United States, 85255
      • Not yet recruiting
      • Investigative Site US240
  • Arkansas
    • Arkansas, Arkansas, United States, 72758
      • Recruiting
      • Investigative Site US214
    • Fayetteville, Arkansas, United States, 72703
      • Not yet recruiting
      • Investigative Site US242
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • Investigative Site US223
    • San Diego, California, United States, 92103
      • Recruiting
      • Investigative Site US226
    • San Francisco, California, United States, 94118
      • Recruiting
      • Investigative Site US222
  • District of Columbia
    • Washington, District of Columbia, United States, 20060
      • Not yet recruiting
      • Investigative Site US233
  • Florida
    • Brandon, Florida, United States, 33511
      • Recruiting
      • Investigative Site US228
    • Margate, Florida, United States, 33063
      • Recruiting
      • Investigative Site US227
    • Miami, Florida, United States, 33125
      • Recruiting
      • Investigative Site US204
    • Miami, Florida, United States, 33173
      • Not yet recruiting
      • Investigative Site US236
    • Ocala, Florida, United States, 34470
      • Recruiting
      • Investigative Site US200
    • Tampa, Florida, United States, 33613
      • Recruiting
      • Investigative Site US201
  • Illinois
    • West Dundee, Illinois, United States, 60118
      • Recruiting
      • Investigative Site US220
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Recruiting
      • Investigative Site US206
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Not yet recruiting
      • Investigative Site US241
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Recruiting
      • Investigative Site US209
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Recruiting
      • Investigative Site US207
    • New Orleans, Louisiana, United States, 70115
      • Recruiting
      • Investigative Site US229
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Recruiting
      • Investigative Site US224
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915
      • Recruiting
      • Investigative Site US208
    • Quincy, Massachusetts, United States, 02169
      • Recruiting
      • Investigative Site US221
  • Michigan
    • Detroit, Michigan, United States, 48084
      • Recruiting
      • Investigative Site US213
    • Waterford, Michigan, United States, 48328
      • Recruiting
      • Investigative Site US217
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • Investigative Site US212
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Not yet recruiting
      • Investigative Site US239
  • New Jersey
    • Hightstown, New Jersey, United States, 08520
      • Recruiting
      • Investigative Site US230
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Not yet recruiting
      • Investigative Site US243
  • New York
    • New York, New York, United States, 10003
      • Recruiting
      • Investigative Site US202
    • Rochester, New York, United States, 14642
      • Recruiting
      • Investigative Site US210
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27516
      • Recruiting
      • Investigative Site US205
  • Ohio
    • Bexley, Ohio, United States, 43209
      • Recruiting
      • Investigative Site US215
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Investigative Site US203
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37130
      • Recruiting
      • Investigative Site US232
  • Texas
    • Arlington, Texas, United States, 76011
      • Not yet recruiting
      • Investigative Site US235
    • Bellaire, Texas, United States, 77401
      • Recruiting
      • Investigative Site US218
    • Pflugerville, Texas, United States, 78660
      • Not yet recruiting
      • Investigative Site US238
    • San Antonio, Texas, United States, 78213
      • Not yet recruiting
      • Investigative Site US234

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male and female participants ≥ 18 years of age.
• Diagnosis of moderate to severe HS ≥ 3 months prior to Screening visit.
• HS lesions present in ≥ 2 distinct anatomic areas, 1 of which must be at least Hurley Stage II or Hurley Stage III, at both the Screening and Baseline visits.
• Total abscess and inflammatory nodule (AN) count ≥ 5 at both the Screening and Baseline visits.
• History of inadequate response to an appropriate course of at least 1 conventional systemic therapy for HS (or demonstrated intolerance to, or have a contraindication to, a conventional systemic therapy for HS)
• Agree to not use certain topical antiseptics on the areas affected by HS lesions during the placebo-controlled period.
• Willingness to avoid pregnancy or fathering children.
• Other inclusion criteria apply.

Exclusion Criteria:

• Draining tunnel count of > 20 at Screening or Baseline visits.
• Women who are pregnant (or who are considering pregnancy) or breastfeeding.
• Medical history including thrombocytopenia, coagulopathy or platelet dysfunction; venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, stroke, moderate to severe heart failure, cerebrovascular accident, myocardial infarction, or other significant cardiovascular diseases; Q-wave interval abnormalities; disseminated herpes zoster or dermatomal herpes zoster; disseminated herpes simplex; chronic/recurrent infections; malignancies.
• Evidence of infection with TB, HBV, HCV or HIV.
• History of failure to JAK inhibitor treatment of any inflammatory disease.
• Laboratory values outside of the protocol-defined ranges.
• Other exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Povorcitinib Dose A; Participants will receive Povorcitinib Dose A for 54 weeks.	Drug: Povorcitinib; Oral, Tablet; Other Names: INCB054707
Experimental: Povorcitinib Dose B; Participants will receive Povorcitinib Dose B for 54 weeks.	Drug: Povorcitinib; Oral, Tablet; Other Names: INCB054707
Placebo Comparator: Placebo; Participants will receive Placebo for 12 weeks, followed by Povorcitinib (Dose A or Dose B) for 42 weeks.	Drug: Placebo; Oral, Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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 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
Proportion of participants with flare	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 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 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

Collaborators and Investigators

• Sponsor: Incyte Corporation

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2023
• Primary Completion (Estimated): March 11, 2025
• Study Completion (Estimated): January 30, 2026

Study Registration Dates

• First Submitted: November 10, 2022
• First Submitted That Met QC Criteria: November 10, 2022
• First Posted (Actual): November 17, 2022

Study Record Updates

• Last Update Posted (Estimated): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: HS; Hidradenitis Suppurativa; Acne inversa; INCB054707; Hidradenitis; Povorcitinib
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis
• Other Study ID Numbers: INCB 54707-302

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