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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
Date last updated
27/06/2024

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
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United States of America
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Graz
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Nice Cedex 3
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Reims
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Rouen
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Saint-priest-en-jarez
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Toulouse
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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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Brescia
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Catania
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Pisa
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Rozzano
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Ibaraki
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Kurume
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Kyoto
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Nakagami-gun
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Niigata-shi
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Nishinomiya-shi
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Sapporo-shi
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Sendai-shi
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Japan
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Tokyo
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Netherlands
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Breda
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Groningen
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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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Wroclaw
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Alicante
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Badalona
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Barcelona
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Granada
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Las Palmas de Gran Canaria
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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
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Spain
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Valencia
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United Kingdom
State/province [120] 0 0
Birmingham
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United Kingdom
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Dudley
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United Kingdom
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Leeds
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United Kingdom
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London
Country [124] 0 0
United Kingdom
State/province [124] 0 0
Salford

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate long-term safety and efficacy of povorcitinib in participants with moderate to severe hidradenitis suppurativa who completed the 54 weeks of study treatment within the originating parent Phase 3 studies (INCB 54707-301 \[NCT05620823\] or INCB 54707-302 \[NCT05620836\]).
Trial website
https://clinicaltrials.gov/study/NCT06212999
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
medinfo@incyte.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06212999