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

Phase 3CompletedNCT05620836

Incyte Corporation619 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

619

Conditions

Hidradenitis Suppurativa (HS)

Interventions

PovorcitinibDRUG

Oral, Tablet

PlaceboDRUG

Oral, Tablet

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (101)

Outcomes

Primary Outcomes

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

Secondary Outcomes

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 at Week 12 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Investigative Site US240

Scottsdale, Arizona, United States

Investigative Site US237

Scottsdale, Arizona, United States

Investigative Site US214

Arkansas City, 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 D.C., District of Columbia, United States

Investigative Site US228

Brandon, Florida, United States

Investigative Site US227

Margate, Florida, United States

...and 91 more locations

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).

Mean change from baseline in Dermatology Life Quality Index (DLQI) score

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

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

Time frame: 54 weeks

Percentage change from baseline in abscess count

Percent Change from baseline in number of abscess(es)

Time frame: 54 weeks

Mean change from baseline in inflammatory nodule count

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

Time frame: 54 weeks

Percentage change from baseline in inflammatory nodule count

Defined as percent change from baseline in number of inflammatory nodule(s)

Time frame: 54 weeks

Mean change from baseline in draining tunnel count

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

Time frame: 54 weeks

Percentage change from baseline in draining tunnel count

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

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 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