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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06212999




Registration number
NCT06212999
Ethics application status
Date submitted
9/01/2024
Date registered
19/01/2024

Titles & IDs
Public title
A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa
Scientific title
A Phase 3, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa
Secondary ID [1] 0 0
2023-507204-31-00
Secondary ID [2] 0 0
INCB 54707-312
Universal Trial Number (UTN)
Trial acronym
STOP-HS LTE
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

Experimental: Cohort A - Povorcitinib at the protocol-defined dose strength based on cohort assignment.

Experimental: Cohort B - Povorcitinib at the protocol-defined dose strength based on cohort assignment.

Experimental: Cohort C - Povorcitinib at the protocol-defined dose strength based on cohort assignment.


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

Outcomes
Primary outcome [1] 0 0
Proportion of participants with Treatment-Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
up to approximately 56 weeks
Secondary outcome [1] 0 0
Proportion of participants with Serious Treatment-Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
up to approximately 56 weeks
Secondary outcome [2] 0 0
Proportion of participants with TEAEs leading to study drug discontinuation
Timepoint [2] 0 0
up to approximately 56 weeks
Secondary outcome [3] 0 0
Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR)
Timepoint [3] 0 0
up to approximately 56 weeks
Secondary outcome [4] 0 0
Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
Timepoint [4] 0 0
up to approximately 56 weeks
Secondary outcome [5] 0 0
Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 90 (HiSCR90)
Timepoint [5] 0 0
up to approximately 56 weeks
Secondary outcome [6] 0 0
Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 100 (HiSCR100)
Timepoint [6] 0 0
up to approximately 56 weeks
Secondary outcome [7] 0 0
Proportion of participants with flare at each visit
Timepoint [7] 0 0
up to approximately 56 weeks
Secondary outcome [8] 0 0
Time to first flare
Timepoint [8] 0 0
up to approximately 56 weeks
Secondary outcome [9] 0 0
Mean change from baseline of parent study in Hidradenitis Suppurativa Quality of Life (HiSQoL) score at each visit
Timepoint [9] 0 0
up to approximately 56 weeks
Secondary outcome [10] 0 0
Mean change from baseline of parent study in Dermatology Life Quality Index (DLQI) score at each visit
Timepoint [10] 0 0
up to approximately 56 weeks
Secondary outcome [11] 0 0
Proportion of participants with no increase in abscess and inflammatory nodule (AN) count relative to Week 54 at each visit
Timepoint [11] 0 0
up to approximately 56 weeks
Secondary outcome [12] 0 0
Proportion of participants with no increase in abscess, inflammatory nodule, and draining tunnel (ANdT) count relative to Week 54 at each visit
Timepoint [12] 0 0
up to approximately 56 weeks
Secondary outcome [13] 0 0
Proportion of participants with no increase in draining tunnel count relative to Week 54 at each visit
Timepoint [13] 0 0
up to approximately 56 weeks
Secondary outcome [14] 0 0
Proportion of participants with a total AN count of 0, 1, or 2 at each visit
Timepoint [14] 0 0
up to approximately 56 weeks
Secondary outcome [15] 0 0
Proportion of participants with a total ANdT count of 0, 1, or 2 at each visit
Timepoint [15] 0 0
up to approximately 56 weeks

Eligibility
Key inclusion criteria
* Completion of the study treatment period of the originating parent study (INCB 54707-301 or INCB 54707-302).
* Agreement to use contraception.
* Willing and able to comply with the study protocol and procedures.
* Further inclusion criteria apply.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participation in the extension study could expose the participant to an undue safety risk.
* Women who are pregnant (or who are considering pregnancy) or breastfeeding.
* Further 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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
26/12/2026
Actual
Sample size
Target
960
Accrual to date
Final
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
Investigator 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
Investigator 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
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Arizona
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Arkansas
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California
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District of Columbia
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Georgia
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Illinois
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Indiana
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Kentucky
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Louisiana
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Maryland
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Michigan
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Missouri
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New Jersey
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North Carolina
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Ohio
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Oregon
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Tennessee
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Virginia
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Washington
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Austria
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Graz
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Austria
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Innsbruck
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Austria
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Linz
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Austria
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Vienna
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Austria
State/province [30] 0 0
Wien
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Belgium
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Brussels
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Gent
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Le Mans Cedex 9
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Lyon
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Marseille Cedex 5
Country [56] 0 0
France
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Nantes
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France
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Nice Cedex 3
Country [58] 0 0
France
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Paris
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France
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Reims
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France
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Rouen
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France
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Saint-priest-en-jarez
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France
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Toulouse
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Berlin
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Bochum
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Darmstadt
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Dessau
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Dresden
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Duesseldorf
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Erlangen
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Frankfurt
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Gottingen
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Hannover
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Kiel
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Langenau
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Leipzig
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Lubeck
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Memmingen
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Merzig
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Greece
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Athens
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Thessaloniki
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Ancona
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Brescia
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Catania
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Napoli
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Pisa
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Rozzano
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Ibaraki
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Kurume
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Nakagami-gun
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Niigata-shi
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Japan
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Tokyo
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Breda
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Groningen
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Netherlands
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Rotterdam
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Poland
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Lublin
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Ostrowiec
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Poznan
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Rzeszow
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Warsaw
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Warszawa
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Wroclaw
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Spain
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Alicante
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Spain
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Badalona
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Spain
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Barcelona
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Spain
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Granada
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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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Pontevedra
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Spain
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Santiago de Compostela
Country [117] 0 0
Spain
State/province [117] 0 0
Valencia
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Birmingham
Country [119] 0 0
United Kingdom
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Dudley
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Leeds
Country [121] 0 0
United Kingdom
State/province [121] 0 0
London
Country [122] 0 0
United Kingdom
State/province [122] 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
Incyte Medical Monitor
Address 0 0
Incyte Corporation
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
[email protected]
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/NCT06212999