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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)
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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
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Secondary ID [1]
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INCB 54707-302
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Universal Trial Number (UTN)
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Trial acronym
STOP-HS2
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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
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
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Intervention code [1]
0
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 who achieve Hidradenitis Suppurativa Clinical Response (HiSCR)
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Assessment method [1]
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HiSCR is defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.
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Timepoint [1]
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Week 12
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Secondary outcome [1]
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Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
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Assessment method [1]
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HiSCR75 is defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.
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Timepoint [1]
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Week 12
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Secondary outcome [2]
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Proportion of participants with flare
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Assessment method [2]
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Participants who experience at least 1 flare over 12 weeks; flare is defined as at least a 25% increase in the total abscess and inflammatory nodule count with a minimum increase of 2 relative to baseline.
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Timepoint [2]
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12 Weeks
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Secondary outcome [3]
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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
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Assessment method [3]
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Participants with a Skin Pain score of at least 3 at baseline and who experience at least a 3-point decrease in Skin Pain score at Week 12, relative to baseline. Skin Pain is an 11-point NRS, ranging from 0 (no skin pain) to 10 (worst skin pain).
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Timepoint [3]
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Week 12
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Secondary outcome [4]
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Proportion of participants who achieve Skin Pain NRS30 at Week 12 among participants with baseline Skin Pain NRS score = 3.
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Assessment method [4]
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Participants with a Skin Pain score of at least 3 at baseline and who achieve at Week 12 Skin Pain NRS30, defined as at least a 30% reduction and at least 1-unit reduction from baseline in the Skin Pain NRS.
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Timepoint [4]
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Week 12
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Secondary outcome [5]
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Proportion of participants with a = 4-point increase from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) score
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Assessment method [5]
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Participants with a baseline FACIT-F score = 48 and who experience at least a 4-point increase in FACIT-F score at Week 12, relative to baseline. The FACIT-F scale is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days, with scores ranging from 0 (worst fatigue) to 52 (no fatigue).
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Timepoint [5]
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Week 12
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Secondary outcome [6]
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Mean change from baseline in Dermatology Life Quality Index (DLQI) score
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Assessment method [6]
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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 [6]
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54 weeks
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Secondary outcome [7]
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Mean change from baseline in abscess count
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Assessment method [7]
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Defined as mean change of abscess(es) count relative to baseline.
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Timepoint [7]
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54 weeks
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Secondary outcome [8]
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0
Percentage change from baseline in abscess count
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Assessment method [8]
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Percent Change from baseline in number of abscess(es)
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Timepoint [8]
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54 weeks
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Secondary outcome [9]
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0
Mean change from baseline in inflammatory nodule count
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Assessment method [9]
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0
Defined as mean change of inflammatory nodule count relative to baseline.
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Timepoint [9]
0
0
54 weeks
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Secondary outcome [10]
0
0
Percentage change from baseline in inflammatory nodule count
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Assessment method [10]
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0
Defined as percent change from baseline in number of inflammatory nodule(s)
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Timepoint [10]
0
0
54 weeks
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Secondary outcome [11]
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0
Mean change from baseline in draining tunnel count
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Assessment method [11]
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Defined as mean change of draining tunnel count relative to baseline.
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Timepoint [11]
0
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54 weeks
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Secondary outcome [12]
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0
Percentage change from baseline in draining tunnel count
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Assessment method [12]
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Defined as Percent change from baseline in number of draining tunnel(s)
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Timepoint [12]
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54 weeks
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Secondary outcome [13]
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Extension Period: Proportion of participants who achieve HiSCR
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Assessment method [13]
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HiSCR is defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.
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Timepoint [13]
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Week 24
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Secondary outcome [14]
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Extension Period: Proportion of participants who achieve HiSCR75
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Assessment method [14]
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HiSCR75 is defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.
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Timepoint [14]
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Week 24
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Secondary outcome [15]
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Extension Period: Proportion of participants with flare
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Assessment method [15]
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Participants who experience at least 1 flare over the period under assessment; flare is defined as at least a 25% increase in the total abscess and inflammatory nodule count with a minimum increase of 2 relative to baseline.
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Timepoint [15]
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From Week 12 through Week 24
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Secondary outcome [16]
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Extension Period: Proportion of participants who achieved Skin Pain NRS30 among participants with baseline Skin Pain NRS score = 3.
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Assessment method [16]
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Skin Pain NRS30 defined as at least a 30% reduction and at least 1-unit reduction from baseline in the Skin Pain NRS.
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Timepoint [16]
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Week 24
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Secondary outcome [17]
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0
Extension Period: Proportion of participants who achieve HiSCR
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Assessment method [17]
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HiSCR is defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.
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Timepoint [17]
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Week 54
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Secondary outcome [18]
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Extension Period: Proportion of participants who achieve HiSCR75
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Assessment method [18]
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HiSCR75 is defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.
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Timepoint [18]
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Week 54
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Secondary outcome [19]
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Extension Period: Proportion of participants with flare
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Assessment method [19]
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Participants who experience at least 1 flare over the period under assessment; flare is defined as at least a 25% increase in the total abscess and inflammatory nodule count with a minimum increase of 2 relative to baseline
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Timepoint [19]
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From Week 12 through Week 54
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Secondary outcome [20]
0
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Extension Period: Proportion of participants who achieved Skin Pain NRS30 among participants with baseline Skin Pain NRS score = 3.
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Assessment method [20]
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Participants with a Skin Pain score of at least 3 at baseline and who achieve Skin Pain NRS30, defined as at least a 30% reduction and at least 1-unit reduction from baseline in the Skin Pain NRS.
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Timepoint [20]
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Week 54
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Secondary outcome [21]
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Extension Period: Proportion of participants who achieve maintenance of HiSCR or greater response at each visit
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Assessment method [21]
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Maintenance of response defined as participants who achieve HiSCR at Week 12 and maintain it or achieve greater response at each visit during the EXT period.
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Timepoint [21]
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From Week 12 through Week 54
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Secondary outcome [22]
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Extension Period: Proportion of participants who achieve maintenance of HiSCR75 or greater response at each visit
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Assessment method [22]
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Maintenance of response defined as participants who achieve HiSCR75 at Week 12 and maintain it or achieve greater response at each visit during the EXT period.
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Timepoint [22]
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From Week 12 through Week 54
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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.
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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
* 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.
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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
22/02/2023
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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
30/01/2026
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Actual
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Sample size
Target
600
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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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Investigative Site AU203 - Kotara
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Investigative Site AU200 - Liverpool
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Investigative Site AU202 - Benowa
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Investigative Site AU206 - Woolloongabba
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Investigative Site AU207 - Woolloongabba
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Recruitment hospital [7]
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Investigative Site AU201 - Carlton
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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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Madrid
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London
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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 the efficacy and safety of Povorcitinib (INCB054707) in participants with moderate to severe Hidradenitis Suppurativa (HS) over a 12-week placebo-controlled period, followed by a 42-week extension period.
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Trial website
https://clinicaltrials.gov/study/NCT05620836
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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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Address
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Phone
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Fax
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Email
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Contact person for public queries
Name
0
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Incyte Corporation Call Center (US)
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Address
0
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Country
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0
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Phone
0
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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)
Query!
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.
Query!
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.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://www.incyte.com/our-company/compliance-and-transparency
Query!
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