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

Phase 3CompletedNCT05620823

Incyte Corporation608 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

608

Conditions

Hidradenitis Suppurativa (HS)

Interventions

PovorcitinibDRUG

Oral; Tablet

PlaceboDRUG

Oral; Tablet

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of moderate to severe HS for at least 3 months prior to the screening visit. * Total abscess and inflammatory nodule count of at least 5 at both the screening and baseline visits * HS lesions in at least 2 distinct anatomical areas (examples include but are not limited to left and right axilla or left and right inguinocrural fold), 1 of which must be at least Hurley Stage II or Hurley Stage III, at both the screening and baseline visits * Documented history of inadequate response to at least a 3-month course of at least 1 conventional systemic therapy (oral antibiotic or biologic drug) for HS (or demonstrated intolerance to, or have a contraindication to, a conventional systemic therapy for treatment of their HS). * Agreement to NOT use topical and systemic antibiotics for treatment of HS during the placebo-controlled period. * Agreement to NOT use a diluted bleach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on the areas affected by HS lesions during the placebo-controlled period. Note: Over-the-counter soap and water is allowed. * Agreement to use contraception * Willing and able to comply with the study protocol and procedures. * Further inclusion criteria apply. Exclusion Criteria: * Presence of \> 20 draining tunnels (fistulas) at either the screening or baseline visit. * Women who are pregnant (or who are considering pregnancy) or breastfeeding. * Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator. * Laboratory values outside of the protocol-defined ranges. * Further exclusion criteria apply.

Locations (104)

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 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

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 US303

Phoenix, Arizona, United States

Investigative Site US335

Arkansas City, Arkansas, United States

Investigative Site US307

Fort Smith, Arkansas, United States

Investigative Site US315

Laguna Niguel, California, United States

Investigative Site US326

Los Angeles, California, United States

Investigative Site US323

San Francisco, California, United States

Investigative Site US306

Boca Raton, Florida, United States

Investigative Site US320

Boca Raton, Florida, United States

Investigative Site US317

Hialeah, Florida, United States

Investigative Site US338

Margate, Florida, United States

...and 94 more locations

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 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

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