Back to resultsA Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa (HS) (STOP-HS2)
Primary Purpose
Hidradenitis Suppurativa (HS)
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Povorcitinib
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hidradenitis Suppurativa (HS) focused on measuring Hidradenitis Suppurativa, HS, INCB054707, Povorcitinib, Acne inversa, Hidradenitis
Eligibility Criteria
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.
Sites / Locations
- Investigative Site US214Recruiting
- Investigative Site US223Recruiting
- Investigative Site US226Recruiting
- Investigative Site US222Recruiting
- Investigative Site US233
- Investigative Site US228Recruiting
- Investigative Site US227Recruiting
- Investigative Site US204Recruiting
- Investigative Site US200Recruiting
- Investigative Site US201Recruiting
- Investigative Site US220Recruiting
- Investigative Site US206Recruiting
- Investigative Site US209Recruiting
- Investigative Site US207Recruiting
- Investigative Site US229Recruiting
- Investigative Site US224
- Investigative Site US208Recruiting
- Investigative Site US225
- Investigative Site US221Recruiting
- Investigative Site US213Recruiting
- Investigative Site US217Recruiting
- Investigative Site US212Recruiting
- Investigative Site US230Recruiting
- Investigative Site US202Recruiting
- Investigative Site US210Recruiting
- Investigative Site US205Recruiting
- Investigative Site US215Recruiting
- Investigative Site US203Recruiting
- Investigative Site US232
- Investigative Site US218Recruiting
- Investigative Site AU205Recruiting
- Investigative Site AU203Recruiting
- Investigative Site AU206
- Investigative Site AU207
- Investigative Site BG203Recruiting
- Investigative Site BG202Recruiting
- Investigative Site BG200Recruiting
- Investigative Site BG204Recruiting
- Investigative Site BG201Recruiting
- Investigative Site CA202Recruiting
- Investigative Site CA204Recruiting
- Investigative Site CA200Recruiting
- Investigative Site CA205Recruiting
- Investigative Site CA207Recruiting
- Investigative Site CA206Recruiting
- Investigative Site CA203Recruiting
- Investigative Site DK201
- Investigative Site DK200
- Investigative Site FR200Recruiting
- Investigative Site FR205Recruiting
- Investigative Site FR204Recruiting
- Investigative Site FR203Recruiting
- Investigative Site FR206
- Investigative Site FR201Recruiting
- Investigative Site DE203
- Investigative Site DE208Recruiting
- Investigative Site DE200Recruiting
- Investigative Site DE204Recruiting
- Investigative Site DE206Recruiting
- Investigative Site IT200Recruiting
- Investigative Site IT204Recruiting
- Investigative Site IT207Recruiting
- Investigative Site IT202Recruiting
- Investigative Site IT206Recruiting
- Investigative Site IT205Recruiting
- Investigative Site PL203Recruiting
- Investigative Site PL200Recruiting
- Investigative Site PL201Recruiting
- Investigative Site PL202Recruiting
- Investigative Site ES203Recruiting
- Investigative Site ES202
- Investigative Site ES204Recruiting
- Investigative Site ES205Recruiting
- Investigative Site ES200Recruiting
- Investigative Site GB202
- Investigative Site GB204
- Investigative Site GB203
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 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.
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
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
Defined as mean change of abscess(es) count relative to baseline.
Percentage change from baseline in abscess count
Percent Change from baseline in number of abscess(es)
Mean change from baseline in inflammatory nodule count
Defined as mean change of inflammatory nodule count relative to baseline.
Percentage change from baseline in inflammatory nodule count
Defined as percent change from baseline in number of inflammatory nodule(s)
Mean change from baseline in draining tunnel count
Defined as mean change of draining tunnel count relative to baseline.
Percentage change from baseline in draining tunnel count
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 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
1. Study Identification
Unique Protocol Identification Number
NCT05620836
Brief Title
A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa (HS)
Acronym
STOP-HS2
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
February 22, 2023 (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, HS, INCB054707, Povorcitinib, Acne inversa, Hidradenitis
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 at Week 12 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
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
Description
Defined as mean change of abscess(es) count relative to baseline.
Time Frame
54 weeks
Title
Percentage change from baseline in abscess count
Description
Percent Change from baseline in number of abscess(es)
Time Frame
54 weeks
Title
Mean change from baseline in inflammatory nodule count
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
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
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
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 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:
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.
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 US214
City
Arkansas
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US223
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US226
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US222
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US233
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site US228
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US227
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US204
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US200
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US201
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US220
City
West Dundee
State/Province
Illinois
ZIP/Postal Code
60118
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US206
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US209
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US207
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US229
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US224
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site US208
City
Beverly
State/Province
Massachusetts
ZIP/Postal Code
01915
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US225
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site US221
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US213
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US217
City
Waterford
State/Province
Michigan
ZIP/Postal Code
48328
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US212
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US230
City
Hightstown
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US202
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US210
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US205
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27516
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US215
City
Bexley
State/Province
Ohio
ZIP/Postal Code
43209
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US203
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site US232
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site US218
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site AU205
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
02217
Country
Australia
Individual Site Status
Recruiting
Facility Name
Investigative Site AU203
City
Kotara
State/Province
New South Wales
ZIP/Postal Code
02289
Country
Australia
Individual Site Status
Recruiting
Facility Name
Investigative Site AU206
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
04102
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site AU207
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
04102
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site BG203
City
Sofia
ZIP/Postal Code
01407
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigative Site BG202
City
Sofia
ZIP/Postal Code
01463
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigative Site BG200
City
Sofia
ZIP/Postal Code
01510
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigative Site BG204
City
Sofia
ZIP/Postal Code
01606
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigative Site BG201
City
Stara Zagora
ZIP/Postal Code
06000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigative Site CA202
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3E 0B2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigative Site CA204
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1C3
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigative Site CA200
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 0C6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigative Site CA205
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 1G9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigative Site CA207
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4W 0C2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigative Site CA206
City
St-jérôme
State/Province
Quebec
ZIP/Postal Code
J7Z 7E2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigative Site CA203
City
St. John's
ZIP/Postal Code
A1A 4Y3
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigative Site DK201
City
Roskilde
ZIP/Postal Code
04000
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site DK200
City
Århus N
ZIP/Postal Code
08200
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site FR200
City
Antony
ZIP/Postal Code
92160
Country
France
Individual Site Status
Recruiting
Facility Name
Investigative Site FR205
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Name
Investigative Site FR204
City
Lyon
ZIP/Postal Code
69003
Country
France
Individual Site Status
Recruiting
Facility Name
Investigative Site FR203
City
Nice Cedex 3
ZIP/Postal Code
06200
Country
France
Individual Site Status
Recruiting
Facility Name
Investigative Site FR206
City
Reims
ZIP/Postal Code
51100
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site FR201
City
Toulon
ZIP/Postal Code
83000
Country
France
Individual Site Status
Recruiting
Facility Name
Investigative Site DE203
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site DE208
City
Gottingen
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigative Site DE200
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigative Site DE204
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigative Site DE206
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigative Site IT200
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigative Site IT204
City
Brescia
ZIP/Postal Code
25124
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigative Site IT207
City
Catania
ZIP/Postal Code
95123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigative Site IT202
City
Milano
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigative Site IT206
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigative Site IT205
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigative Site PL203
City
Lublin
ZIP/Postal Code
20573
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigative Site PL200
City
Rzeszow
ZIP/Postal Code
35-055
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigative Site PL201
City
Warszawa
ZIP/Postal Code
02-807
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigative Site PL202
City
Warszawa
ZIP/Postal Code
02-962
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigative Site ES203
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigative Site ES202
City
Las Palmas de Gran Canaria
ZIP/Postal Code
35019
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site ES204
City
Madrid
ZIP/Postal Code
28005
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigative Site ES205
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigative Site ES200
City
Manises
ZIP/Postal Code
46940
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigative Site GB202
City
Birmingham
ZIP/Postal Code
B15 2GW
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site GB204
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site GB203
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Individual Site Status
Not yet 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 (HS)
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