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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
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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
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Secondary ID [1]
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0
2023-507204-31-00
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Secondary ID [2]
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INCB 54707-312
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Universal Trial Number (UTN)
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Trial acronym
STOP-HS LTE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hidradenitis Suppurativa (HS)
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of participants with Treatment-Emergent Adverse Events (TEAEs)
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Assessment method [1]
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TEAE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug.
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Timepoint [1]
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up to approximately 56 weeks
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Secondary outcome [1]
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Proportion of participants with Serious Treatment-Emergent Adverse Events (TEAEs)
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Assessment method [1]
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Serious TEAE is defined as any untoward medical occurrence that, at any dose, meet at least one of the following criteria: (a) results in death; (b) is life-threatening; (c) requires inpatient hospitalization or prolongation of existing hospitalization; (d) results in persistent or significant disability/incapacity; (e) is a congenital anomaly/birth defect; (f) is an important medical event.
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Timepoint [1]
0
0
up to approximately 56 weeks
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Secondary outcome [2]
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Proportion of participants with TEAEs leading to study drug discontinuation
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Assessment method [2]
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Defined as any TEAE that leads to discontinuation of study drug.
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Timepoint [2]
0
0
up to approximately 56 weeks
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Secondary outcome [3]
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Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR)
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Assessment method [3]
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HiSCR is defined as at least a 50% reduction from baseline of parent study in the total abscess and inflammatory nodule (AN) count, with no increase from baseline of parent study in abscess or draining tunnel count.
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Timepoint [3]
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0
up to approximately 56 weeks
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Secondary outcome [4]
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Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
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Assessment method [4]
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HiSCR75 is defined as at least a 75% reduction from baseline of parent study in the total AN count, with no increase from baseline of parent study in abscess or draining tunnel count.
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Timepoint [4]
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up to approximately 56 weeks
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Secondary outcome [5]
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Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 90 (HiSCR90)
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Assessment method [5]
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HiSCR90 is defined as at least a 90% reduction from baseline of parent study in the total AN count, with no increase from baseline of parent study in abscess or draining tunnel count.
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Timepoint [5]
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up to approximately 56 weeks
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Secondary outcome [6]
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Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 100 (HiSCR100)
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Assessment method [6]
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HiSCR100 is defined as a 100% reduction from baseline of parent study in the total AN count, with no increase from baseline of parent study in abscess or draining tunnel count.
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Timepoint [6]
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0
up to approximately 56 weeks
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Secondary outcome [7]
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Proportion of participants with flare at each visit
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Assessment method [7]
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Flare is defined as at least a 25% increase in the total AN count with a minimum increase of 2 ANs relative to Week 54.
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Timepoint [7]
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0
up to approximately 56 weeks
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Secondary outcome [8]
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Time to first flare
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Assessment method [8]
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Time to first flare during the long-term extension study.
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Timepoint [8]
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up to approximately 56 weeks
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Secondary outcome [9]
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Mean change from baseline of parent study in Hidradenitis Suppurativa Quality of Life (HiSQoL) score at each visit
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Assessment method [9]
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The HiSQoL is a HS-specific, health-related quality of life (QoL) instrument. The HiSQoL total score ranges from 0 to 68, with higher scores indicating higher disease impact on QoL.
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Timepoint [9]
0
0
up to approximately 56 weeks
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Secondary outcome [10]
0
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Mean change from baseline of parent study in Dermatology Life Quality Index (DLQI) score at each visit
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Assessment method [10]
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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.
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Timepoint [10]
0
0
up to approximately 56 weeks
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Secondary outcome [11]
0
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Proportion of participants with no increase in abscess and inflammatory nodule (AN) count relative to Week 54 at each visit
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Assessment method [11]
0
0
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Timepoint [11]
0
0
up to approximately 56 weeks
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Secondary outcome [12]
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Proportion of participants with no increase in abscess, inflammatory nodule, and draining tunnel (ANdT) count relative to Week 54 at each visit
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Assessment method [12]
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ANdT count is defined as the total sum of abscesses, inflammatory nodules, and draining tunnels.
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Timepoint [12]
0
0
up to approximately 56 weeks
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Secondary outcome [13]
0
0
Proportion of participants with no increase in draining tunnel count relative to Week 54 at each visit
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Assessment method [13]
0
0
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Timepoint [13]
0
0
up to approximately 56 weeks
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Secondary outcome [14]
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Proportion of participants with a total AN count of 0, 1, or 2 at each visit
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Assessment method [14]
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AN count defined as the total sum of abscesses and inflammatory nodules.
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Timepoint [14]
0
0
up to approximately 56 weeks
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Secondary outcome [15]
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Proportion of participants with a total ANdT count of 0, 1, or 2 at each visit
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Assessment method [15]
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ANdT count is defined as the total sum of abscesses, inflammatory nodules, and draining tunnels.
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Timepoint [15]
0
0
up to approximately 56 weeks
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/01/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
26/12/2026
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Actual
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Sample size
Target
960
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Investigative Site AU205 - Kogarah
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Recruitment hospital [2]
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Investigative Site AU203 - Kotara
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Recruitment hospital [3]
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Investigator Site AU200 - Liverpool
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Recruitment hospital [4]
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Investigative Site AU202 - Benowa
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Recruitment hospital [5]
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Investigative Site AU206 - Woolloongabba
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Recruitment hospital [6]
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Investigative Site AU207 - Woolloongabba
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Recruitment hospital [7]
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Investigator Site AU201 - Carlton
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Recruitment hospital [8]
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Investigative Site AU204 - Melbourne
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Recruitment postcode(s) [1]
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02217 - Kogarah
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Recruitment postcode(s) [2]
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02289 - Kotara
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Recruitment postcode(s) [3]
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02170 - Liverpool
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Recruitment postcode(s) [4]
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04217 - Benowa
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Recruitment postcode(s) [5]
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04102 - Woolloongabba
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Recruitment postcode(s) [6]
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03053 - Carlton
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Recruitment postcode(s) [7]
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03002 - Melbourne
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Recruitment outside Australia
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United States of America
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Arizona
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United States of America
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California
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United States of America
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0
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District of Columbia
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0
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United States of America
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0
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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Indiana
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United States of America
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Kentucky
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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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Missouri
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Graz
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Praha 5
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Poznan
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Poland
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State/province [105]
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Rzeszow
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Country [106]
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Poland
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State/province [106]
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Warsaw
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Country [107]
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Poland
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State/province [107]
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Warszawa
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Country [108]
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Poland
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State/province [108]
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Wroclaw
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Country [109]
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Spain
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State/province [109]
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Alicante
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Spain
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State/province [110]
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Badalona
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Spain
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State/province [111]
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Barcelona
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Country [112]
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Spain
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State/province [112]
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Granada
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Country [113]
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Spain
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State/province [113]
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Las Palmas de Gran Canaria
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Country [114]
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Spain
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State/province [114]
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Madrid
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Country [115]
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Spain
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State/province [115]
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Pontevedra
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Country [116]
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Spain
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State/province [116]
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Santiago de Compostela
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Country [117]
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Spain
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State/province [117]
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Valencia
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Country [118]
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United Kingdom
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State/province [118]
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Birmingham
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Country [119]
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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
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Country [122]
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United Kingdom
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Salford
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Incyte Corporation
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Address
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Country
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Ethics approval
Ethics application status
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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 \[NCT05620836\]).
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Trial website
https://clinicaltrials.gov/study/NCT06212999
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Incyte Medical Monitor
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Address
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Incyte Corporation
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Email
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Contact person for public queries
Name
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Incyte Corporation Call Center (US)
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Address
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Phone
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1.855.463.3463
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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)
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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.
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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.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.incyte.com/our-company/compliance-and-transparency
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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