A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa (HS)

Phase 3

Active, not recruiting

• Conditions: Hidradenitis Suppurativa (HS)
• Interventions: Drug: Povorcitinib; Drug: Placebo

• Registration Number: NCT05620836
• Lead Sponsor: Incyte Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-10
• Study First Submitted QC: 2022-11-10
• Study First Posted: 2022-11-17
• Study Start: 2023-02-22
• Primary Completion: 2025-01-07
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-03
• Last Update Posted: 2025-07-04
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 619

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.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Povorcitinib Dose A	Povorcitinib	Participants will receive Povorcitinib Dose A for 54 weeks.
Placebo	Placebo	Participants will receive Placebo for 12 weeks, followed by Povorcitinib (Dose A or Dose B) for 42 weeks.
Povorcitinib Dose B	Povorcitinib	Participants will receive Povorcitinib Dose B for 54 weeks.

Primary Outcome Measures

Name	Time	Method
Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR)	Week 12	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.

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline in Dermatology Life Quality Index (DLQI) score	54 weeks	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.
Extension Period: Proportion of participants who achieve HiSCR	Week 54	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.
Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)	Week 12	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.
Proportion of participants with flare	12 Weeks	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.
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	Week 12	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).
Proportion of participants who achieve Skin Pain NRS30 at Week 12 among participants with baseline Skin Pain NRS score ≥ 3.	Week 12	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.
Proportion of participants with a ≥ 4-point increase from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) score	Week 12	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).
Mean change from baseline in abscess count	54 weeks	Defined as mean change of abscess(es) count relative to baseline.
Mean change from baseline in draining tunnel count	54 weeks	Defined as mean change of draining tunnel count relative to baseline.
Percentage change from baseline in draining tunnel count	54 weeks	Defined as Percent change from baseline in number of draining tunnel(s)
Percentage change from baseline in abscess count	54 weeks	Percent Change from baseline in number of abscess(es)
Mean change from baseline in inflammatory nodule count	54 weeks	Defined as mean change of inflammatory nodule count relative to baseline.
Percentage change from baseline in inflammatory nodule count	54 weeks	Defined as percent change from baseline in number of inflammatory nodule(s)
Extension Period: Proportion of participants who achieve HiSCR75	Week 54	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.
Extension Period: Proportion of participants with flare	From Week 12 through Week 54	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
Extension Period: Proportion of participants who achieved Skin Pain NRS30 among participants with baseline Skin Pain NRS score ≥ 3.	Week 54	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.
Extension Period: Proportion of participants who achieve maintenance of HiSCR or greater response at each visit	From Week 12 through Week 54	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.
Extension Period: Proportion of participants who achieve maintenance of HiSCR75 or greater response at each visit	From Week 12 through Week 54	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.

Trial Locations

Locations (101)

Investigative Site US240; 🇺🇸 Scottsdale, Arizona, United States

Investigative Site US237; 🇺🇸 Scottsdale, Arizona, United States

Investigative Site US214; 🇺🇸 Arkansas, Arkansas, United States

Investigative Site US242; 🇺🇸 Fayetteville, Arkansas, United States

Investigative Site US223; 🇺🇸 Los Angeles, California, United States

Investigative Site US226; 🇺🇸 San Diego, California, United States

Investigative Site US222; 🇺🇸 San Francisco, California, United States

Investigative Site US233; 🇺🇸 Washington, District of Columbia, United States

Investigative Site US228; 🇺🇸 Brandon, Florida, United States

Investigative Site US227; 🇺🇸 Margate, Florida, United States

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