A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa (STOP-HS1)

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: Placebo; Drug: Povorcitinib

• 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

• Austria
  • Graz, Austria, 08036
    • Recruiting
    • Investigative Site AT304
  • Innsbruck, Austria, 06020
    • Recruiting
    • Investigative Site AT306
  • Innsbruck, Austria, 06020
    • Recruiting
    • Investigative Site 00A
  • Linz, Austria, 04020
    • Recruiting
    • Investigative Site AT302
  • Vienna, Austria, 01090
    • Recruiting
    • Investigative Site AT305
  • Wien, Austria, 01100
    • Recruiting
    • Investigative Site AT301
• Belgium
  • Brussels, Belgium, 01200
    • Recruiting
    • Investigative Site BE304
  • Bruxelles, Belgium, 01070
    • Recruiting
    • Investigative Site BE300
  • Gent, Belgium, 09000
    • Recruiting
    • Investigative Site BE306
  • Ghent, Belgium, 09000
    • Recruiting
    • Investigative Site BE301
  • Leuven, Belgium, 03000
    • Recruiting
    • Investigative Site BE305
  • Liege, Belgium, 04000
    • Recruiting
    • Investigative Site BE302
  • Namur, Belgium, 05000
    • Recruiting
    • Investigative Site BE303
• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Recruiting
      • Investigative Site CA301
  • Ontario
    • Barrie, Ontario, Canada, L4M 1G7
      • Recruiting
      • Investigative Site CA304
    • Hamilton, Ontario, Canada, L8L 3C3
      • Not yet recruiting
      • Investigative Site CA308
    • London, Ontario, Canada, N6H 5L5
      • Recruiting
      • Investigative Site CA303
    • Peterborough, Ontario, Canada, K9J 5K2
      • Recruiting
      • Investigative Site CA302
  • Quebec
    • Laval, Quebec, Canada, H7N 6L2
      • Recruiting
      • Investigative Site CA306
    • Montreal, Quebec, Canada, H2K 4L5
      • Recruiting
      • Investigative Site CA307
• Czechia
  • Ostrava - Poruba, Czechia, 708 52
    • Recruiting
    • Investigative Site CZ301
  • Praha 5, Czechia, 150 06
    • Recruiting
    • Investigative Site CZ300
• France
  • Bordeaux, France, 33000
    • Recruiting
    • Investigative Site FR305
  • Brest Cedex 2, France, 29609
    • Recruiting
    • Investigative Site FR303
  • Le Mans Cedex, France, 72037
    • Recruiting
    • Investigative Site FR307
  • Marseille, France, 13385
    • Recruiting
    • Investigative Site FR304
  • Nantes Cedex 1, France, 44093
    • Recruiting
    • Investigative Site FR302
  • Paris, France, 75010
    • Recruiting
    • Investigative Site FR300
  • Saint Priest En Jarez, France, 42270
    • Recruiting
    • Investigative Site FR301
  • Toulouse Cedex 9, France, 31059
    • Recruiting
    • Investigative Site FR306
• Germany
  • Darmstadt, Germany, 64283
    • Recruiting
    • Investigative Site DE305
  • Dresden, Germany, 01307
    • Recruiting
    • Investigative Site DE302
  • Duesseldorf, Germany, 40225
    • Recruiting
    • Investigative Site DE306
  • Frankfurt Am Main, Germany, 60590
    • Recruiting
    • Investigative Site DE301
  • Hamburg, Germany, 20246
    • Recruiting
    • Investigative Site DE303
  • Hannover, Germany, 30519
    • Recruiting
    • Investigative Site DE300
  • Langenau, Germany, 89129
    • Recruiting
    • Investigative Site DE304
  • Memmingen, Germany, 87700
    • Recruiting
    • Investigative Site DE307
• Greece
  • Athens, Greece, 12462
    • Recruiting
    • Investigative Site GR300
  • Athens, Greece, 16121
    • Recruiting
    • Investigative Site GR303
  • Thessaloniki, Greece, 54643
    • Recruiting
    • Investigative Site GR301
  • Thessaloniki, Greece, 56403
    • Recruiting
    • Investigative Site GR302
• Japan
  • Itabashi-ku, Japan, 173-8610
    • Recruiting
    • Investigative Site JP304
  • Kurume-shi, Japan, 830-0011
    • Recruiting
    • Investigative Site JP305
  • Kyoto-shi, Japan, 602-8566
    • Recruiting
    • Investigative Site JP300
  • Nakagami-gun, Japan, 903-0215
    • Recruiting
    • Investigative Site JP301
  • Niigata-shi, Japan, 951-8520
    • Recruiting
    • Investigative Site JP303
  • Nishinomiya-shi, Japan, 663-8186
    • Recruiting
    • Investigative Site JP307
  • Sapporo-shi, Japan, 060-8648
    • Recruiting
    • Investigative Site JP308
  • Sendai-shi, Japan, 980-8574
    • Recruiting
    • Investigative Site JP302
  • Shinjuku-ku, Japan, 160-0023
    • Recruiting
    • Investigative Site JP309
  • Tsukuba-shi, Japan, 305-8576
    • Recruiting
    • Investigative Site JP306
• Netherlands
  • Breda, Netherlands, 4818 CK
    • Recruiting
    • Investigative Site NL302
  • Groningen, Netherlands, 9713 GZ
    • Recruiting
    • Investigative Site NL303
  • Rotterdam, Netherlands, 3015 GD
    • Recruiting
    • Investigative Site NL301
• Poland
  • Ostrowiec, Poland, 27-400
    • Recruiting
    • Investigative Site PL304
  • Poznan, Poland, 60-529
    • Recruiting
    • Investigative Site PL303
  • Wroclaw, Poland, 50-566
    • Recruiting
    • Investigative Site PL301
  • Wroclaw, Poland, 51-318
    • Recruiting
    • Investigative Site PL302
• Spain
  • Badalona, Spain, 08916
    • Recruiting
    • Investigative Site ES302
  • Barcelona, Spain, 08003
    • Recruiting
    • Investigative Site ES303
  • Granada, Spain, 18014
    • Recruiting
    • Investigative Site ES301
  • Madrid, Spain, 28041
    • Recruiting
    • Investigative Site ES305
  • Pontevedra, Spain, 36001
    • Recruiting
    • Investigative Site ES300
  • Santiago de Compostela, Spain, 15706
    • Recruiting
    • Investigative Site ES304
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Recruiting
      • Investigative Site US303
  • Arkansas
    • Fort Smith, Arkansas, United States, 72916
      • Recruiting
      • Investigative Site US307
  • California
    • Laguna Niguel, California, United States, 92677
      • Recruiting
      • Investigative Site US315
    • Los Angeles, California, United States, 90045
      • Recruiting
      • Investigative Site US326
    • San Francisco, California, United States, 94118
      • Recruiting
      • Investigative Site US323
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Recruiting
      • Investigative Site US306
    • Boca Raton, Florida, United States, 33486
      • Recruiting
      • Investigative Site US320
    • Hialeah, Florida, United States, 33012-3618
      • Recruiting
      • Investigative Site US317
    • North Miami Beach, Florida, United States, 33162-4708
      • Recruiting
      • Investigative Site US321
    • Orlando, Florida, United States, 32819
      • Recruiting
      • Investigative Site US316
    • Tampa, Florida, United States, 33612
      • Not yet recruiting
      • Investigative Site US328
  • Georgia
    • Marietta, Georgia, United States, 30060-1047
      • Recruiting
      • Investigative Site US311
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Not yet recruiting
      • Investigative Site US327
    • Skokie, Illinois, United States, 60077
      • Recruiting
      • Investigative Site US319
  • Maryland
    • Columbia, Maryland, United States, 21045
      • Not yet recruiting
      • Investigative Site US325
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915
      • Recruiting
      • Investigative Site US318
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Investigative Site US304
    • Brighton, Massachusetts, United States, 02135
      • Recruiting
      • Investigative Site US310
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Investigative Site US302
  • New York
    • Kew Gardens, New York, United States, 11415
      • Recruiting
      • Investigative Site US324
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • Investigative Site US314
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • Investigative Site US312
  • Oregon
    • Portland, Oregon, United States, 97223
      • Recruiting
      • Investigative Site US301
  • Texas
    • Plano, Texas, United States, 75025
      • Recruiting
      • Investigative Site US300
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Recruiting
      • Investigative Site US313
  • Washington
    • Spokane, Washington, United States, 99202
      • Recruiting
      • Investigative Site US308

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Diagnosis of moderate to severe HS for at least 3 months prior to the screening visit.
• Total abscess and inflammatory nodule count of at least 5 at both the screening and baseline visits
• HS lesions in at least 2 distinct anatomical areas (examples include but are not limited to left and right axilla or left and right inguinocrural fold), 1 of which must be at least Hurley Stage II or Hurley Stage III, at both the screening and baseline visits
• Documented history of inadequate response to at least a 3-month course of at least 1 conventional systemic therapy (oral antibiotic or biologic drug) for HS (or demonstrated intolerance to, or have a contraindication to, a conventional systemic therapy for treatment of their HS).
• Agreement to NOT use topical and systemic antibiotics for treatment of HS during the placebo-controlled period.
• Agreement to NOT use a diluted bleach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on the areas affected by HS lesions during the placebo-controlled period. Note: Over-the-counter soap and water is allowed.
• Agreement to use contraception
• Willing and able to comply with the study protocol and procedures.
• Further inclusion criteria apply.

Exclusion Criteria:

• Presence of > 20 draining tunnels (fistulas) at either the screening or baseline visit.
• Women who are pregnant (or who are considering pregnancy) or breastfeeding.
• Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.
• Laboratory values outside of the protocol-defined ranges.
• Further 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
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 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 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.	54 weeks
Mean change from baseline in abscess count at each visit.	Defined as mean change of Abscess count relative to baseline.	54 weeks
Percentage change from baseline in abscess count at every visit	Percent change from baseline in number of abscess(es)	54 weeks
Mean change from baseline in inflammatory nodule count at each visit	Defined as mean change of inflammatory nodule count relative to baseline.	54 weeks
Percentage change from baseline in inflammatory nodule count at each visit.	Defined as percent change from baseline in number of inflammatory nodule(s)	54 weeks
Mean change from baseline in draining tunnel count at each visit.	Defined as mean change of draining tunnel count relative to baseline.	54 weeks
Percentage change from baseline in draining tunnel count at each visit.	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 at Week 24 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): December 19, 2022
• 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 54707-301

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