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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05620836




Registration number
NCT05620836
Ethics application status
Date submitted
10/11/2022
Date registered
17/11/2022
Date last updated
26/03/2025

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa (HS)
Scientific title
A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa
Secondary ID [1] 0 0
INCB 54707-302
Universal Trial Number (UTN)
Trial acronym
STOP-HS2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hidradenitis Suppurativa (HS) 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Povorcitinib
Treatment: Drugs - Placebo

Experimental: Povorcitinib Dose A - Participants will receive Povorcitinib Dose A for 54 weeks.

Experimental: Povorcitinib Dose B - Participants will receive Povorcitinib Dose B for 54 weeks.

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


Treatment: Drugs: Povorcitinib
Oral, Tablet

Treatment: Drugs: Placebo
Oral, Tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR)
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Proportion of participants with flare
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
12 Weeks
Secondary outcome [3] 0 0
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
Assessment method [3] 0 0
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).
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Proportion of participants who achieve Skin Pain NRS30 at Week 12 among participants with baseline Skin Pain NRS score = 3.
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Proportion of participants with a = 4-point increase from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) score
Assessment method [5] 0 0
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).
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Mean change from baseline in Dermatology Life Quality Index (DLQI) score
Assessment method [6] 0 0
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.
Timepoint [6] 0 0
54 weeks
Secondary outcome [7] 0 0
Mean change from baseline in abscess count
Assessment method [7] 0 0
Defined as mean change of abscess(es) count relative to baseline.
Timepoint [7] 0 0
54 weeks
Secondary outcome [8] 0 0
Percentage change from baseline in abscess count
Assessment method [8] 0 0
Percent Change from baseline in number of abscess(es)
Timepoint [8] 0 0
54 weeks
Secondary outcome [9] 0 0
Mean change from baseline in inflammatory nodule count
Assessment method [9] 0 0
Defined as mean change of inflammatory nodule count relative to baseline.
Timepoint [9] 0 0
54 weeks
Secondary outcome [10] 0 0
Percentage change from baseline in inflammatory nodule count
Assessment method [10] 0 0
Defined as percent change from baseline in number of inflammatory nodule(s)
Timepoint [10] 0 0
54 weeks
Secondary outcome [11] 0 0
Mean change from baseline in draining tunnel count
Assessment method [11] 0 0
Defined as mean change of draining tunnel count relative to baseline.
Timepoint [11] 0 0
54 weeks
Secondary outcome [12] 0 0
Percentage change from baseline in draining tunnel count
Assessment method [12] 0 0
Defined as Percent change from baseline in number of draining tunnel(s)
Timepoint [12] 0 0
54 weeks
Secondary outcome [13] 0 0
Extension Period: Proportion of participants who achieve HiSCR
Assessment method [13] 0 0
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.
Timepoint [13] 0 0
Week 24
Secondary outcome [14] 0 0
Extension Period: Proportion of participants who achieve HiSCR75
Assessment method [14] 0 0
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.
Timepoint [14] 0 0
Week 24
Secondary outcome [15] 0 0
Extension Period: Proportion of participants with flare
Assessment method [15] 0 0
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.
Timepoint [15] 0 0
From Week 12 through Week 24
Secondary outcome [16] 0 0
Extension Period: Proportion of participants who achieved Skin Pain NRS30 among participants with baseline Skin Pain NRS score = 3.
Assessment method [16] 0 0
Skin Pain NRS30 defined as at least a 30% reduction and at least 1-unit reduction from baseline in the Skin Pain NRS.
Timepoint [16] 0 0
Week 24
Secondary outcome [17] 0 0
Extension Period: Proportion of participants who achieve HiSCR
Assessment method [17] 0 0
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.
Timepoint [17] 0 0
Week 54
Secondary outcome [18] 0 0
Extension Period: Proportion of participants who achieve HiSCR75
Assessment method [18] 0 0
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.
Timepoint [18] 0 0
Week 54
Secondary outcome [19] 0 0
Extension Period: Proportion of participants with flare
Assessment method [19] 0 0
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
Timepoint [19] 0 0
From Week 12 through Week 54
Secondary outcome [20] 0 0
Extension Period: Proportion of participants who achieved Skin Pain NRS30 among participants with baseline Skin Pain NRS score = 3.
Assessment method [20] 0 0
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.
Timepoint [20] 0 0
Week 54
Secondary outcome [21] 0 0
Extension Period: Proportion of participants who achieve maintenance of HiSCR or greater response at each visit
Assessment method [21] 0 0
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.
Timepoint [21] 0 0
From Week 12 through Week 54
Secondary outcome [22] 0 0
Extension Period: Proportion of participants who achieve maintenance of HiSCR75 or greater response at each visit
Assessment method [22] 0 0
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.
Timepoint [22] 0 0
From Week 12 through Week 54

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Draining tunnel count of > 20 at Screening or Baseline visits.
* Women who are pregnant (or who are considering pregnancy) or breastfeeding.
* Medical history including thrombocytopenia, coagulopathy or platelet dysfunction; venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, stroke, moderate to severe heart failure, cerebrovascular accident, myocardial infarction, or other significant cardiovascular diseases; Q-wave interval abnormalities; disseminated herpes zoster or dermatomal herpes zoster; disseminated herpes simplex; chronic/recurrent infections; malignancies.
* Evidence of infection with TB, HBV, HCV or HIV.
* History of failure to JAK inhibitor treatment of any inflammatory disease.
* Laboratory values outside of the protocol-defined ranges.
* Other exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/01/2026
Actual
Sample size
Target
Accrual to date
Final
619
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Investigative Site AU205 - Kogarah
Recruitment hospital [2] 0 0
Investigative Site AU203 - Kotara
Recruitment hospital [3] 0 0
Investigative Site AU200 - Liverpool
Recruitment hospital [4] 0 0
Investigative Site AU202 - Benowa
Recruitment hospital [5] 0 0
Investigative Site AU206 - Woolloongabba
Recruitment hospital [6] 0 0
Investigative Site AU207 - Woolloongabba
Recruitment hospital [7] 0 0
Investigative Site AU201 - Carlton
Recruitment hospital [8] 0 0
Investigative Site AU204 - Melbourne
Recruitment postcode(s) [1] 0 0
02217 - Kogarah
Recruitment postcode(s) [2] 0 0
02289 - Kotara
Recruitment postcode(s) [3] 0 0
02170 - Liverpool
Recruitment postcode(s) [4] 0 0
04217 - Benowa
Recruitment postcode(s) [5] 0 0
04102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
03053 - Carlton
Recruitment postcode(s) [7] 0 0
03002 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
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Maryland
Country [12] 0 0
United States of America
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Massachusetts
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Michigan
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Minnesota
Country [15] 0 0
United States of America
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Nebraska
Country [16] 0 0
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New Jersey
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New York
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North Carolina
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Ohio
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Tennessee
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United States of America
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Texas
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Bulgaria
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Sofia
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Bulgaria
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Stara Zagora
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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New Brunswick
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Canada
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Ontario
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Canada
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Quebec
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Canada
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St. John's
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Denmark
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Roskilde
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Denmark
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Århus N
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France
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Antony
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France
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Dijon
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France
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Lyon
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France
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Nice Cedex 3
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France
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Reims
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France
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Rouen Cedex
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France
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Toulon
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Germany
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MA
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Dessau
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Germany
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Erlangen
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Germany
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Gottingen
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Germany
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Heidelberg
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Germany
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Kiel
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Germany
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Luebeck
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Germany
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Mainz
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Italy
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Ancona
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Italy
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Brescia
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Italy
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Catania
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Italy
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Milano
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Italy
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Napoli
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Italy
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Pisa
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Italy
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Roma
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Italy
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Rozzano
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Poland
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Lublin
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Poland
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Rzeszow
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Poland
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Warszawa
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Spain
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Alicante
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Spain
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Las Palmas de Gran Canaria
Country [62] 0 0
Spain
State/province [62] 0 0
Madrid
Country [63] 0 0
Spain
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Manises
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Birmingham
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Dudley
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Leeds
Country [67] 0 0
United Kingdom
State/province [67] 0 0
London
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Salford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Incyte Corporation
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Incyte Corporation Call Center (US)
Address 0 0
Country 0 0
Phone 0 0
1.855.463.3463
Email 0 0
medinfo@incyte.com
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05620836