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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

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)
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Proportion of participants with flare
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
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.
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
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Mean change from baseline in Dermatology Life Quality Index (DLQI) score
Timepoint [6] 0 0
54 weeks
Secondary outcome [7] 0 0
Mean change from baseline in abscess count
Timepoint [7] 0 0
54 weeks
Secondary outcome [8] 0 0
Percentage change from baseline in abscess count
Timepoint [8] 0 0
54 weeks
Secondary outcome [9] 0 0
Mean change from baseline in inflammatory nodule count
Timepoint [9] 0 0
54 weeks
Secondary outcome [10] 0 0
Percentage change from baseline in inflammatory nodule count
Timepoint [10] 0 0
54 weeks
Secondary outcome [11] 0 0
Mean change from baseline in draining tunnel count
Timepoint [11] 0 0
54 weeks
Secondary outcome [12] 0 0
Percentage change from baseline in draining tunnel count
Timepoint [12] 0 0
54 weeks
Secondary outcome [13] 0 0
Extension Period: Proportion of participants who achieve HiSCR
Timepoint [13] 0 0
Week 24
Secondary outcome [14] 0 0
Extension Period: Proportion of participants who achieve HiSCR75
Timepoint [14] 0 0
Week 24
Secondary outcome [15] 0 0
Extension Period: Proportion of participants with flare
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.
Timepoint [16] 0 0
Week 24
Secondary outcome [17] 0 0
Extension Period: Proportion of participants who achieve HiSCR
Timepoint [17] 0 0
Week 54
Secondary outcome [18] 0 0
Extension Period: Proportion of participants who achieve HiSCR75
Timepoint [18] 0 0
Week 54
Secondary outcome [19] 0 0
Extension Period: Proportion of participants with flare
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.
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
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
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
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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
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Kentucky
Country [10] 0 0
United States of America
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Nebraska
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New Jersey
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New York
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Ohio
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Tennessee
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Texas
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Sofia
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Stara Zagora
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Roskilde
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France
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Lyon
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France
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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
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Spain
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Madrid
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Spain
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Manises
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Birmingham
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United Kingdom
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Dudley
Country [66] 0 0
United Kingdom
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Leeds
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United Kingdom
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London
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Salford

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 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
Fax 0 0
Email 0 0
medinfo@incyte.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.incyte.com/our-company/compliance-and-transparency


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