A Phase 3 interventional study of Povorcitinib and Placebo in Hidradenitis Suppurativa (HS), sponsored by Incyte Corporation. Completed at 104 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-10.
Sponsored by Incyte Corporation · Phase 3, Interventional, and Treatment
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.
277 studies on the registry are indexed under Hidradenitis Suppurativa; 88 are open to participants now.
This study's enrollment of 608 is above the median of 45 across 195 interventional studies indexed under Hidradenitis Suppurativa.
Browse Hidradenitis Suppurativa studies →Incyte Corporation is the lead sponsor of 286 studies on the registry; 37 are open to participants now.
Of its 144 completed or terminated interventional studies of FDA-regulated products, 93 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive Povorcitinib Dose A for 54 weeks.
Drug: Povorcitinib
Participants will receive Povorcitinib Dose B for 54 weeks.
Drug: Povorcitinib
Participants will receive Placebo for 12 weeks, followed by Povorcitinib (Dose A or Dose B) for 42 weeks.
Drug: Placebo
Oral; Tablet
Also known as: INCB054707
Oral; Tablet
Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR)
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.
Time frame: Week 12
Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
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.
Time frame: Week 12
Proportion of participants with flare
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.
Time frame: 12 weeks
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.
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).
Time frame: Week 12
Proportion of participants who achieve Skin Pain NRS30 among participants with baseline Skin Pain NRS score ≥ 3.
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.
Time frame: Week 12
Proportion of participants with a ≥ 4-point increase from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT F) score
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).
Time frame: Week 12
Mean change from baseline in Dermatology Life Quality Index (DLQI) score at each visit
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.
Time frame: 54 weeks
Mean change from baseline in abscess count at each visit.
Defined as mean change of Abscess count relative to baseline.
Time frame: 54 weeks
Percentage change from baseline in abscess count at every visit
Percent change from baseline in number of abscess(es)
Time frame: 54 weeks
Mean change from baseline in inflammatory nodule count at each visit
Defined as mean change of inflammatory nodule count relative to baseline.
Time frame: 54 weeks
Percentage change from baseline in inflammatory nodule count at each visit.
Defined as percent change from baseline in number of inflammatory nodule(s)
Time frame: 54 weeks
Mean change from baseline in draining tunnel count at each visit.
Defined as mean change of draining tunnel count relative to baseline.
Time frame: 54 weeks
Percentage change from baseline in draining tunnel count at each visit.
Defined as percent change from baseline in number of draining tunnel(s)
Time frame: 54 weeks
Extension Period: Proportion of participants who achieve HiSCR
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.
Time frame: Week 24
Extension Period: Proportion of participants who achieve HiSCR75
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.
Time frame: Week 24
Extension Period: Proportion of participants with flare
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.
Time frame: From Week 12 through Week 24
Extension Period: Proportion of participants who achieved Skin Pain NRS30 among participants with baseline Skin Pain NRS score ≥ 3
Skin Pain NRS30 defined as at least a 30% reduction and at least 1-unit reduction from baseline in the Skin Pain NRS.
Time frame: Week 24
Extension Period: Proportion of participants who achieve HiSCR
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
Time frame: Week 54
Extension Period: Proportion of participants who achieve HiSCR75
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.
Time frame: Week 54
Extension Period : Proportion of participants with flare
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.
Time frame: From Week 12 through Week 54
Extension Period: Proportion of participants who achieved Skin Pain NRS30 among participants with baseline Skin Pain NRS score ≥ 3.
Participants with a Skin Pain score of at least 3 at baseline and who achieve at Week 24 Skin Pain NRS30, defined as at least a 30% reduction and at least 1-unit reduction from baseline in the Skin Pain NRS.
Time frame: Week 54
Extension Period:Proportion of participants who achieve maintenance of HiSCR or greater response at each visit
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.
Time frame: From Week 12 through Week 54
Extension Period : Proportion of participants who achieve maintenance of HiSCR75 or greater response at each visit
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.
Time frame: From Week 12 through Week 54
Showing the first 100 of 104 sites across 12 countries.
Plan to share: Yes — 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 information: Study protocol, Sap
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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