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

Primary Purpose

Hidradenitis Suppurativa (HS)

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Povorcitinib
Placebo
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa (HS) focused on measuring Hidradenitis Suppurativa, Hidradenitis, Acne inversa, HS, INCB054707, Povorcitinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigative Site US303Recruiting
  • Investigative Site US307Recruiting
  • Investigative Site US315Recruiting
  • Investigative Site US323
  • Investigative Site US306Recruiting
  • Investigative Site US320Recruiting
  • Investigative Site US317Recruiting
  • Investigative Site US321Recruiting
  • Investigative Site US316Recruiting
  • Investigative Site US311Recruiting
  • Investigative Site US319Recruiting
  • Investigative Site US318Recruiting
  • Investigative Site US304Recruiting
  • Investigative Site US310Recruiting
  • Investigative Site US302Recruiting
  • Investigative Site US324Recruiting
  • Investigative Site US314Recruiting
  • Investigative Site US312Recruiting
  • Investigative Site US301Recruiting
  • Investigative Site US300Recruiting
  • Investigative Site US313Recruiting
  • Investigative Site US308Recruiting
  • Investigative Site AT304
  • Investigative Site AT306
  • Investigative Site AT302
  • Investigative Site AT303
  • Investigative Site AT305
  • Investigative Site AT301Recruiting
  • Investigative Site AT300
  • Investigative Site BE304Recruiting
  • Investigative Site BE300
  • Investigative Site BE301Recruiting
  • Investigative Site BE306Recruiting
  • Investigative Site BE305Recruiting
  • Investigative Site BE302
  • Investigative Site BE303Recruiting
  • Investigative Site CA301Recruiting
  • Investigative Site CA304Recruiting
  • Investigative Site CA303Recruiting
  • Investigative Site CA302Recruiting
  • Investigative Site CA306Recruiting
  • Investigative Site CA307Recruiting
  • Investigative Site CZ301Recruiting
  • Investigative Site CZ300Recruiting
  • Investigative Site FR305Recruiting
  • Investigative Site FR303Recruiting
  • Investigative Site FR307Recruiting
  • Investigative Site FR304
  • Investigative Site FR302Recruiting
  • Investigative Site FR301Recruiting
  • Investigative Site FR306Recruiting
  • Investigative Site DE305Recruiting
  • Investigative Site DE302Recruiting
  • Investigative Site DE306
  • Investigative Site DE301
  • Investigative Site DE303Recruiting
  • Investigative Site DE300Recruiting
  • Investigative Site DE304Recruiting
  • Investigative Site DE307
  • Investigative Site GR300Recruiting
  • Investigative Site GR303Recruiting
  • Investigative Site GR301Recruiting
  • Investigative Site JP304Recruiting
  • Investigative Site JP305
  • Investigative Site JP300Recruiting
  • Investigative Site JP301Recruiting
  • Investigative Site JP303Recruiting
  • Investigative Site JP307Recruiting
  • Investigative Site JP308Recruiting
  • Investigative Site JP302Recruiting
  • Investigative Site JP309Recruiting
  • Investigative Site JP306
  • Investigative Site NL302Recruiting
  • Investigative Site NL303Recruiting
  • Investigative Site NL301Recruiting
  • Investigative Site PL303Recruiting
  • Investigative Site PL301Recruiting
  • Investigative Site PL302Recruiting
  • Investigative Site ES302Recruiting
  • Investigative Site ES303Recruiting
  • Investigative Site ES301Recruiting
  • Investigative Site ES305Recruiting
  • Investigative Site ES300Recruiting
  • Investigative Site ES304Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Povorcitinib Dose A

Povorcitinib Dose B

Placebo

Arm Description

Participants will receive Povorcitinib Dose A for 54 weeks.

Participants will receive Povorcitinib Dose B for 54 weeks.

Participants will receive Placebo for 12 weeks, followed by Povorcitinib (Dose A or Dose B) for 42 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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).
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.
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).
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.
Mean change from baseline in abscess count at each visit.
Defined as mean change of Abscess count relative to baseline.
Percentage change from baseline in abscess count at every visit
Percent change from baseline in number of abscess(es)
Mean change from baseline in inflammatory nodule count at each visit
Defined as mean change of inflammatory nodule count relative to baseline.
Percentage change from baseline in inflammatory nodule count at each visit.
Defined as percent change from baseline in number of inflammatory nodule(s)
Mean change from baseline in draining tunnel count at each visit.
Defined as mean change of draining tunnel count relative to baseline.
Percentage change from baseline in draining tunnel count at each visit.
Defined as percent change from baseline in number of draining tunnel(s)
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.
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.
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.
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.
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
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.
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.
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.
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.
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.

Full Information

First Posted
November 10, 2022
Last Updated
October 18, 2023
Sponsor
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05620823
Brief Title
A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa
Acronym
STOP-HS1
Official Title
A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 19, 2022 (Actual)
Primary Completion Date
March 11, 2025 (Anticipated)
Study Completion Date
January 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa (HS)
Keywords
Hidradenitis Suppurativa, Hidradenitis, Acne inversa, HS, INCB054707, Povorcitinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized 1:1:1 to Povorcitinib Dose A, Povorcitinib Dose B, or placebo once a day (QD); participants who complete the placebo controlled (PC) 12-week period may continue to a 42-week extension(EXT) period with Povorcitinib (Dose A or Dose B) QD.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Povorcitinib Dose A
Arm Type
Experimental
Arm Description
Participants will receive Povorcitinib Dose A for 54 weeks.
Arm Title
Povorcitinib Dose B
Arm Type
Experimental
Arm Description
Participants will receive Povorcitinib Dose B for 54 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive Placebo for 12 weeks, followed by Povorcitinib (Dose A or Dose B) for 42 weeks.
Intervention Type
Drug
Intervention Name(s)
Povorcitinib
Other Intervention Name(s)
INCB054707
Intervention Description
Oral; Tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral; Tablet
Primary Outcome Measure Information:
Title
Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR)
Description
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.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
Description
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.
Time Frame
Week 12
Title
Proportion of participants with flare
Description
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.
Time Frame
12 weeks
Title
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.
Description
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).
Time Frame
Week 12
Title
Proportion of participants who achieve Skin Pain NRS30 among participants with baseline Skin Pain NRS score ≥ 3.
Description
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.
Time Frame
Week 12
Title
Proportion of participants with a ≥ 4-point increase from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT F) score
Description
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).
Time Frame
Week 12
Title
Mean change from baseline in Dermatology Life Quality Index (DLQI) score at each visit
Description
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.
Time Frame
54 weeks
Title
Mean change from baseline in abscess count at each visit.
Description
Defined as mean change of Abscess count relative to baseline.
Time Frame
54 weeks
Title
Percentage change from baseline in abscess count at every visit
Description
Percent change from baseline in number of abscess(es)
Time Frame
54 weeks
Title
Mean change from baseline in inflammatory nodule count at each visit
Description
Defined as mean change of inflammatory nodule count relative to baseline.
Time Frame
54 weeks
Title
Percentage change from baseline in inflammatory nodule count at each visit.
Description
Defined as percent change from baseline in number of inflammatory nodule(s)
Time Frame
54 weeks
Title
Mean change from baseline in draining tunnel count at each visit.
Description
Defined as mean change of draining tunnel count relative to baseline.
Time Frame
54 weeks
Title
Percentage change from baseline in draining tunnel count at each visit.
Description
Defined as percent change from baseline in number of draining tunnel(s)
Time Frame
54 weeks
Title
Extension Period: Proportion of participants who achieve HiSCR
Description
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.
Time Frame
Week 24
Title
Extension Period: Proportion of participants who achieve HiSCR75
Description
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.
Time Frame
Week 24
Title
Extension Period: Proportion of participants with flare
Description
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.
Time Frame
From Week 12 through Week 24
Title
Extension Period: Proportion of participants who achieved Skin Pain NRS30 among participants with baseline Skin Pain NRS score ≥ 3
Description
Skin Pain NRS30 defined as at least a 30% reduction and at least 1-unit reduction from baseline in the Skin Pain NRS.
Time Frame
Week 24
Title
Extension Period: Proportion of participants who achieve HiSCR
Description
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
Time Frame
Week 54
Title
Extension Period: Proportion of participants who achieve HiSCR75
Description
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.
Time Frame
Week 54
Title
Extension Period : Proportion of participants with flare
Description
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.
Time Frame
From Week 12 through Week 54
Title
Extension Period: Proportion of participants who achieved Skin Pain NRS30 among participants with baseline Skin Pain NRS score ≥ 3.
Description
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.
Time Frame
Week 54
Title
Extension Period:Proportion of participants who achieve maintenance of HiSCR or greater response at each visit
Description
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.
Time Frame
From Week 12 through Week 54
Title
Extension Period : Proportion of participants who achieve maintenance of HiSCR75 or greater response at each visit
Description
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.
Time Frame
From Week 12 through Week 54

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Incyte Corporation Call Center (US)
Phone
1.855.463.3463
Email
medinfo@incyte.com
First Name & Middle Initial & Last Name or Official Title & Degree
Incyte Corporation Call Center (ex-US)
Phone
+800 00027423
Email
eumedinfo@incyte.com
Facility Information:
Facility Name
Investigative Site US303
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US307
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72916
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US315
City
Laguna Niguel
State/Province
California
ZIP/Postal Code
92677
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US323
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site US306
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US320
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US317
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012-3618
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US321
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162-4708
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US316
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US311
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060-1047
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US319
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US318
City
Beverly
State/Province
Massachusetts
ZIP/Postal Code
01915
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US304
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US310
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US302
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US324
City
Kew Gardens
State/Province
New York
ZIP/Postal Code
11415
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US314
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US312
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US301
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US300
City
Plano
State/Province
Texas
ZIP/Postal Code
75025
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US313
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US308
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site AT304
City
Graz
ZIP/Postal Code
08036
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site AT306
City
Innsbruck
ZIP/Postal Code
06020
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site AT302
City
Linz
ZIP/Postal Code
04020
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site AT303
City
Vienna
ZIP/Postal Code
01030
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site AT305
City
Vienna
ZIP/Postal Code
01090
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site AT301
City
Wien
ZIP/Postal Code
01100
Country
Austria
Individual Site Status
Recruiting
Facility Name
Investigative Site AT300
City
Wien
ZIP/Postal Code
01130
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site BE304
City
Brussels
ZIP/Postal Code
01200
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Investigative Site BE300
City
Bruxelles
ZIP/Postal Code
01070
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site BE301
City
Gent
ZIP/Postal Code
09000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Investigative Site BE306
City
Gent
ZIP/Postal Code
09000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Investigative Site BE305
City
Leuven
ZIP/Postal Code
03000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Investigative Site BE302
City
Liege
ZIP/Postal Code
04000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site BE303
City
Namur
ZIP/Postal Code
05000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Investigative Site CA301
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigative Site CA304
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 1G7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigative Site CA303
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 5L5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigative Site CA302
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigative Site CA306
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7N 6L2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigative Site CA307
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2K 4L5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigative Site CZ301
City
Ostrava - Poruba
ZIP/Postal Code
708 52
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Investigative Site CZ300
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Investigative Site FR305
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Name
Investigative Site FR303
City
Brest Cedex 2
ZIP/Postal Code
29609
Country
France
Individual Site Status
Recruiting
Facility Name
Investigative Site FR307
City
Le Mans Cedex
ZIP/Postal Code
72037
Country
France
Individual Site Status
Recruiting
Facility Name
Investigative Site FR304
City
Marseille
ZIP/Postal Code
13385
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site FR302
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Name
Investigative Site FR301
City
Saint Priest En Jarez
ZIP/Postal Code
42270
Country
France
Individual Site Status
Recruiting
Facility Name
Investigative Site FR306
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
Investigative Site DE305
City
Darmstadt
ZIP/Postal Code
64283
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigative Site DE302
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigative Site DE306
City
Duesseldorf
ZIP/Postal Code
40225
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site DE301
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site DE303
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigative Site DE300
City
Hannover
ZIP/Postal Code
30519
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigative Site DE304
City
Langenau
ZIP/Postal Code
89129
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigative Site DE307
City
Memmingen
ZIP/Postal Code
87700
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site GR300
City
Athens
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Name
Investigative Site GR303
City
Athens
ZIP/Postal Code
16121
Country
Greece
Individual Site Status
Recruiting
Facility Name
Investigative Site GR301
City
Thessaloniki
ZIP/Postal Code
54643
Country
Greece
Individual Site Status
Recruiting
Facility Name
Investigative Site JP304
City
Itabashi-ku
ZIP/Postal Code
173-8610
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigative Site JP305
City
Kurume-shi
ZIP/Postal Code
830-0011
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site JP300
City
Kyoto-shi
ZIP/Postal Code
602-8566
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigative Site JP301
City
Nakagami-gun
ZIP/Postal Code
903-0215
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigative Site JP303
City
Niigata-shi
ZIP/Postal Code
951-8520
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigative Site JP307
City
Nishinomiya-shi
ZIP/Postal Code
663-8186
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigative Site JP308
City
Sapporo-shi
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigative Site JP302
City
Sendai-shi
ZIP/Postal Code
980-8574
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigative Site JP309
City
Shinjuku-ku
ZIP/Postal Code
160-0023
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigative Site JP306
City
Tsukuba-shi
ZIP/Postal Code
305-8576
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site NL302
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Investigative Site NL303
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Investigative Site NL301
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Investigative Site PL303
City
Poznan
ZIP/Postal Code
60-529
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigative Site PL301
City
Wroclaw
ZIP/Postal Code
50-566
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigative Site PL302
City
Wroclaw
ZIP/Postal Code
51-318
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigative Site ES302
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigative Site ES303
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigative Site ES301
City
Granada
ZIP/Postal Code
18014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigative Site ES305
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigative Site ES300
City
Pontevedra
ZIP/Postal Code
36001
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigative Site ES304
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.incyte.com/our-company/compliance-and-transparency

Learn more about this trial

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

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