Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06855498




Registration number
NCT06855498
Ethics application status
Date submitted
26/02/2025
Date registered
3/03/2025
Date last updated
4/07/2025

Titles & IDs
Public title
Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
Scientific title
A Phase 3b, Multicenter, Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
Secondary ID [1] 0 0
2024-520107-12-00
Secondary ID [2] 0 0
INCB054707-801
Universal Trial Number (UTN)
Trial acronym
STOP-LTR
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: povorcitinib - Participants will receive povorcitinib treatment with the same schedule and dose options as the study in which they originally enrolled.


Treatment: Drugs: povorcitinib
Study drug will be taken orally as defined by the protocol.
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 3 years
Secondary outcome [1] 0 0
Proportion of participants with a total ANdT count of 0, 1, or 2 at each visit
Timepoint [1] 0 0
Up to approximately 3 years

Eligibility
Key inclusion criteria
* Ability to comprehend and willingness to sign a written ICF for the study.
* Completed the treatment period of a predetermined, Incyte-sponsored, povorcitinib parent study without safety or tolerability concerns, per investigator's assessment.
* Received clinical benefit from treatment with study drug during the parent study, as determined by the investigator.
* Demonstrated compliance, as assessed by the investigator, with the parent Protocol requirements.
* Willingness to avoid pregnancy or fathering children as defined in the protocol.
* Willingness and ability to comply with the study Protocol and procedures.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Had been permanently discontinued from study treatment during the parent study.
* Had temporary study drug interruption due to safety and/or efficacy reasons at or after the final visit of the parent study.
* Received at least 1 dose of either of the following therapies within the 28 days prior to starting treatment in this rollover study:

* Biologic immunomodulator (examples include but are not limited to adalimumab, bimekizumab, dupilumab, infliximab, nemolizumab, secukinumab).
* Live, attenuated vaccine.
* Plans for administration of a live, attenuated vaccine during this study or within 8 weeks after the last dose of study drug.
* Women who are pregnant (or who are considering pregnancy) or breastfeeding.
* Known hypersensitivity or severe reaction to povorcitinib or excipients of povorcitinib and/or other products in the same class.
* Currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
* Any condition that would, in the investigator's and/or sponsor's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
28/02/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/02/2028
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Investigative Site AU003 - Kogarah
Recruitment hospital [2] 0 0
Investigative Site AU005 - Liverpool
Recruitment hospital [3] 0 0
Investigative Site AU001 - Newcastle
Recruitment hospital [4] 0 0
Investigative Site AU010 - Sydney
Recruitment hospital [5] 0 0
Investigative Site AU007 - Wolloongabba
Recruitment hospital [6] 0 0
Investigative Site AU006 - Woolloongabba
Recruitment hospital [7] 0 0
Investigative Site AU004 - Carlton
Recruitment hospital [8] 0 0
Investigative Site AU002 - East Melbourne
Recruitment hospital [9] 0 0
Investigative Site AU008 - Fremantle
Recruitment hospital [10] 0 0
Investigative Site AU009 - Westmead
Recruitment postcode(s) [1] 0 0
02217 - Kogarah
Recruitment postcode(s) [2] 0 0
02170 - Liverpool
Recruitment postcode(s) [3] 0 0
02289 - Newcastle
Recruitment postcode(s) [4] 0 0
02010 - Sydney
Recruitment postcode(s) [5] 0 0
04102 - Wolloongabba
Recruitment postcode(s) [6] 0 0
04102 - Woolloongabba
Recruitment postcode(s) [7] 0 0
03053 - Carlton
Recruitment postcode(s) [8] 0 0
03002 - East Melbourne
Recruitment postcode(s) [9] 0 0
06160 - Fremantle
Recruitment postcode(s) [10] 0 0
02145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
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
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
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
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
New Hampshire
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Oklahoma
Country [21] 0 0
United States of America
State/province [21] 0 0
Oregon
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
Tennessee
Country [24] 0 0
United States of America
State/province [24] 0 0
Texas
Country [25] 0 0
United States of America
State/province [25] 0 0
Utah
Country [26] 0 0
United States of America
State/province [26] 0 0
Virginia
Country [27] 0 0
United States of America
State/province [27] 0 0
Washington
Country [28] 0 0
Argentina
State/province [28] 0 0
Buenos Aires
Country [29] 0 0
Argentina
State/province [29] 0 0
Ciudad Autonoma de Buenos Aires
Country [30] 0 0
Argentina
State/province [30] 0 0
Mar Del Plata
Country [31] 0 0
Argentina
State/province [31] 0 0
Rosario
Country [32] 0 0
Argentina
State/province [32] 0 0
San Miguel de Tucuman
Country [33] 0 0
Austria
State/province [33] 0 0
Graz
Country [34] 0 0
Austria
State/province [34] 0 0
Innsbruck
Country [35] 0 0
Austria
State/province [35] 0 0
Vienna
Country [36] 0 0
Austria
State/province [36] 0 0
Wien
Country [37] 0 0
Belgium
State/province [37] 0 0
Brugge
Country [38] 0 0
Belgium
State/province [38] 0 0
Brussel
Country [39] 0 0
Belgium
State/province [39] 0 0
Gent
Country [40] 0 0
Belgium
State/province [40] 0 0
Liege
Country [41] 0 0
Belgium
State/province [41] 0 0
Loverval
Country [42] 0 0
Belgium
State/province [42] 0 0
Woluwe-saint-lambert
Country [43] 0 0
Bulgaria
State/province [43] 0 0
Dupnitsa
Country [44] 0 0
Bulgaria
State/province [44] 0 0
Lovech
Country [45] 0 0
Bulgaria
State/province [45] 0 0
Pleven
Country [46] 0 0
Bulgaria
State/province [46] 0 0
Plovdiv
Country [47] 0 0
Bulgaria
State/province [47] 0 0
Sevlievo
Country [48] 0 0
Bulgaria
State/province [48] 0 0
Sofia
Country [49] 0 0
Bulgaria
State/province [49] 0 0
Stara Zagora
Country [50] 0 0
Canada
State/province [50] 0 0
Alberta
Country [51] 0 0
Canada
State/province [51] 0 0
British Columbia
Country [52] 0 0
Canada
State/province [52] 0 0
Manitoba
Country [53] 0 0
Canada
State/province [53] 0 0
New Brunswick
Country [54] 0 0
Canada
State/province [54] 0 0
Ontario
Country [55] 0 0
Canada
State/province [55] 0 0
Quebec
Country [56] 0 0
Canada
State/province [56] 0 0
Saskatchewan
Country [57] 0 0
Chile
State/province [57] 0 0
LAS Condes Santiago
Country [58] 0 0
Chile
State/province [58] 0 0
Santiago
Country [59] 0 0
Chile
State/province [59] 0 0
Valdivia
Country [60] 0 0
Czechia
State/province [60] 0 0
Ostrava-poruba
Country [61] 0 0
Czechia
State/province [61] 0 0
Prague
Country [62] 0 0
Denmark
State/province [62] 0 0
Aarhus
Country [63] 0 0
Denmark
State/province [63] 0 0
Roskilde
Country [64] 0 0
France
State/province [64] 0 0
Antony
Country [65] 0 0
France
State/province [65] 0 0
Bordeaux
Country [66] 0 0
France
State/province [66] 0 0
Brest
Country [67] 0 0
France
State/province [67] 0 0
Creteil
Country [68] 0 0
France
State/province [68] 0 0
Dijon
Country [69] 0 0
France
State/province [69] 0 0
Le Mans
Country [70] 0 0
France
State/province [70] 0 0
Lyon
Country [71] 0 0
France
State/province [71] 0 0
Marseille
Country [72] 0 0
France
State/province [72] 0 0
Mulhouse
Country [73] 0 0
France
State/province [73] 0 0
Nantes
Country [74] 0 0
France
State/province [74] 0 0
Nice
Country [75] 0 0
France
State/province [75] 0 0
Paris
Country [76] 0 0
France
State/province [76] 0 0
Reims
Country [77] 0 0
France
State/province [77] 0 0
Romans Sur Isere
Country [78] 0 0
France
State/province [78] 0 0
Rouen Cedex
Country [79] 0 0
France
State/province [79] 0 0
Saint Priest En Jarez
Country [80] 0 0
France
State/province [80] 0 0
Toulouse Cedex 9
Country [81] 0 0
France
State/province [81] 0 0
Toulouse
Country [82] 0 0
Germany
State/province [82] 0 0
Aachen
Country [83] 0 0
Germany
State/province [83] 0 0
Bad Bentheim
Country [84] 0 0
Germany
State/province [84] 0 0
Berlin
Country [85] 0 0
Germany
State/province [85] 0 0
Bochum
Country [86] 0 0
Germany
State/province [86] 0 0
Bonn
Country [87] 0 0
Germany
State/province [87] 0 0
Buxtehude
Country [88] 0 0
Germany
State/province [88] 0 0
Chemnitz
Country [89] 0 0
Germany
State/province [89] 0 0
Darmstadt
Country [90] 0 0
Germany
State/province [90] 0 0
Dessau-rosslau
Country [91] 0 0
Germany
State/province [91] 0 0
Dortmund
Country [92] 0 0
Germany
State/province [92] 0 0
Dresden
Country [93] 0 0
Germany
State/province [93] 0 0
Dusseldorf
Country [94] 0 0
Germany
State/province [94] 0 0
Erlangen
Country [95] 0 0
Germany
State/province [95] 0 0
Frankfurt Am Main
Country [96] 0 0
Germany
State/province [96] 0 0
Friedrichshafen
Country [97] 0 0
Germany
State/province [97] 0 0
Gottingen
Country [98] 0 0
Germany
State/province [98] 0 0
Halle
Country [99] 0 0
Germany
State/province [99] 0 0
Hamburg
Country [100] 0 0
Germany
State/province [100] 0 0
Hannover
Country [101] 0 0
Germany
State/province [101] 0 0
Heidelberg
Country [102] 0 0
Germany
State/province [102] 0 0
Kiel
Country [103] 0 0
Germany
State/province [103] 0 0
Leipzig
Country [104] 0 0
Germany
State/province [104] 0 0
Luebeck
Country [105] 0 0
Germany
State/province [105] 0 0
Magdeburg
Country [106] 0 0
Germany
State/province [106] 0 0
Mahlow
Country [107] 0 0
Germany
State/province [107] 0 0
Mainz
Country [108] 0 0
Germany
State/province [108] 0 0
Marburg
Country [109] 0 0
Germany
State/province [109] 0 0
Merzig
Country [110] 0 0
Germany
State/province [110] 0 0
Muenchen
Country [111] 0 0
Germany
State/province [111] 0 0
Oldenburg
Country [112] 0 0
Germany
State/province [112] 0 0
Tuebingen
Country [113] 0 0
Germany
State/province [113] 0 0
Witten
Country [114] 0 0
Greece
State/province [114] 0 0
Athens
Country [115] 0 0
Greece
State/province [115] 0 0
Thessaloniki
Country [116] 0 0
Hungary
State/province [116] 0 0
Debrecen
Country [117] 0 0
Hungary
State/province [117] 0 0
Szombathely
Country [118] 0 0
Italy
State/province [118] 0 0
Bari
Country [119] 0 0
Italy
State/province [119] 0 0
Brescia
Country [120] 0 0
Italy
State/province [120] 0 0
Catania
Country [121] 0 0
Italy
State/province [121] 0 0
Chieti
Country [122] 0 0
Italy
State/province [122] 0 0
L'aquila
Country [123] 0 0
Italy
State/province [123] 0 0
Milano
Country [124] 0 0
Italy
State/province [124] 0 0
Milan
Country [125] 0 0
Italy
State/province [125] 0 0
Naples
Country [126] 0 0
Italy
State/province [126] 0 0
Perugia
Country [127] 0 0
Italy
State/province [127] 0 0
Rome
Country [128] 0 0
Italy
State/province [128] 0 0
Rozzano
Country [129] 0 0
Italy
State/province [129] 0 0
Torrette DI Ancona
Country [130] 0 0
Korea, Republic of
State/province [130] 0 0
Ansan-si
Country [131] 0 0
Korea, Republic of
State/province [131] 0 0
Bucheon-si
Country [132] 0 0
Korea, Republic of
State/province [132] 0 0
Busan
Country [133] 0 0
Korea, Republic of
State/province [133] 0 0
Incheon
Country [134] 0 0
Korea, Republic of
State/province [134] 0 0
Jeonju-si
Country [135] 0 0
Korea, Republic of
State/province [135] 0 0
Seoul
Country [136] 0 0
Korea, Republic of
State/province [136] 0 0
Yangsan-si
Country [137] 0 0
Netherlands
State/province [137] 0 0
Amsterdam
Country [138] 0 0
Netherlands
State/province [138] 0 0
Bergen Op Zoom
Country [139] 0 0
Netherlands
State/province [139] 0 0
Breda
Country [140] 0 0
Netherlands
State/province [140] 0 0
Groningen
Country [141] 0 0
Netherlands
State/province [141] 0 0
Rotterdam
Country [142] 0 0
Netherlands
State/province [142] 0 0
Veldhoven
Country [143] 0 0
Poland
State/province [143] 0 0
Cracov
Country [144] 0 0
Poland
State/province [144] 0 0
Gdansk
Country [145] 0 0
Poland
State/province [145] 0 0
Grodzisk Mazowiecki
Country [146] 0 0
Poland
State/province [146] 0 0
Katowice
Country [147] 0 0
Poland
State/province [147] 0 0
Kielce
Country [148] 0 0
Poland
State/province [148] 0 0
Lublin
Country [149] 0 0
Poland
State/province [149] 0 0
Ostrowiec Swietokrzyski
Country [150] 0 0
Poland
State/province [150] 0 0
Rzeszow
Country [151] 0 0
Poland
State/province [151] 0 0
Szczecin
Country [152] 0 0
Poland
State/province [152] 0 0
Tarnow
Country [153] 0 0
Poland
State/province [153] 0 0
Torun
Country [154] 0 0
Poland
State/province [154] 0 0
Warsaw
Country [155] 0 0
Poland
State/province [155] 0 0
Warszawa
Country [156] 0 0
Poland
State/province [156] 0 0
Wrocaw
Country [157] 0 0
Poland
State/province [157] 0 0
Wroclaw
Country [158] 0 0
Spain
State/province [158] 0 0
Badalona
Country [159] 0 0
Spain
State/province [159] 0 0
Barcelona
Country [160] 0 0
Spain
State/province [160] 0 0
Cordoba
Country [161] 0 0
Spain
State/province [161] 0 0
Granada
Country [162] 0 0
Spain
State/province [162] 0 0
Las Palmas de Gran Canaria
Country [163] 0 0
Spain
State/province [163] 0 0
Madrid
Country [164] 0 0
Spain
State/province [164] 0 0
Manises
Country [165] 0 0
Spain
State/province [165] 0 0
Pamplona
Country [166] 0 0
Spain
State/province [166] 0 0
Santiago de Compostela
Country [167] 0 0
Spain
State/province [167] 0 0
Valencia
Country [168] 0 0
Switzerland
State/province [168] 0 0
Bern
Country [169] 0 0
Switzerland
State/province [169] 0 0
Buochs
Country [170] 0 0
Switzerland
State/province [170] 0 0
Zurich
Country [171] 0 0
United Kingdom
State/province [171] 0 0
Birmingham
Country [172] 0 0
United Kingdom
State/province [172] 0 0
Dudley
Country [173] 0 0
United Kingdom
State/province [173] 0 0
Ipswich
Country [174] 0 0
United Kingdom
State/province [174] 0 0
Leeds
Country [175] 0 0
United Kingdom
State/province [175] 0 0
Leicester
Country [176] 0 0
United Kingdom
State/province [176] 0 0
Liverpool
Country [177] 0 0
United Kingdom
State/province [177] 0 0
London
Country [178] 0 0
United Kingdom
State/province [178] 0 0
Poole
Country [179] 0 0
United Kingdom
State/province [179] 0 0
Salford
Country [180] 0 0
United Kingdom
State/province [180] 0 0
Wolverhampton

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/NCT06855498