Completed

NCT Number: NCT05620836

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

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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Key information

Conditions

Hidradenitis Suppurativa (HS) Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Hidradenitis Suppurativa Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigative Site AU205, Kogarah, New South Wales, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Povorcitinib

Drug

Oral, Tablet

Other names: INCB054707

Placebo

Drug

Oral, Tablet

Primary outcomes

Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR)

Time frame: 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 outcomes

Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 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 Dermatology Life Quality Index (DLQI) score

Time frame: 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.
Mean change from baseline in abscess count

Time frame: 54 weeks

Defined as mean change of abscess(es) count relative to baseline.
Percentage change from baseline in abscess count

Time frame: 54 weeks

Percent Change from baseline in number of abscess(es)
Mean change from baseline in inflammatory nodule count

Time frame: 54 weeks

Defined as mean change of inflammatory nodule count relative to baseline.
Percentage change from baseline in inflammatory nodule count

Time frame: 54 weeks

Defined as percent change from baseline in number of inflammatory nodule(s)
Mean change from baseline in draining tunnel count

Time frame: 54 weeks

Defined as mean change of draining tunnel count relative to baseline.
Percentage change from baseline in draining tunnel count

Time frame: 54 weeks

Defined as Percent change from baseline in number of draining tunnel(s)
Extension Period: Proportion of participants who achieve HiSCR

Time frame: Week 24

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.
Extension Period: Proportion of participants who achieve HiSCR75

Time frame: Week 24

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

Time frame: From Week 12 through Week 24

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.

Time frame: 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.
Extension Period: Proportion of participants who achieve HiSCR

Time frame: 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.
Extension Period: Proportion of participants who achieve HiSCR75

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study title

A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa

Acronym: STOP-HS2

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Nov 17, 2022
Registry last updated: Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed