Acne Inversa

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

Incyte Study ID:
INCB 54707-302
CT.gov ID:
NCT05620836
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Recruitment Complete
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Clinical Study Purpose

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.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Acne Inversa
    • PRODUCT
  • Drug: Povorcitinib
  • Drug: Placebo
    • COLLABORATORS
    N/A
    DATE
    Feb 2023 - Jan 2025
    TYPE
    Interventional
    PHASE
    Phase 3
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Male and female participants ≥ 18 years of age.
    • Diagnosis of moderate to severe HS ≥ 3 months prior to Screening visit.

    Exclusion Criteria

    • Draining tunnel count of > 20 at Screening or Baseline visits.
    • Women who are pregnant (or who are considering pregnancy) or breastfeeding.

    Clinical Study Locations

    Location
    Status
    Location
    Investigative Site CA206
    ST-JÉRÔME, QC, Canada, J7Z 7E2
    Status
    Recruiting
    Location
    Investigative Site AU206
    WOOLLOONGABBA, QLD, Australia, 04102
    Status
    Recruiting
    Location
    Investigative Site DE208
    GOTTINGEN, Germany, 37075
    Status
    Recruiting
    Location
    Investigative Site DK200
    ÅRHUS N, Denmark, 08200
    Status
    Recruiting
    Location
    Investigative Site DK201
    ROSKILDE, Denmark, 04000
    Status
    Recruiting
    Location
    Investigative Site ES204
    MADRID, Spain, 28005
    Status
    Recruiting

    Protocol Summary

    Incyte Study ID:
    INCB 54707-302
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
    Interventions:
    Drug
    Enrollment:
    619
    Primary Outcome
    Open

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

    Timeframe: Week 12

    Secondary Outcome
    Open

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

    Timeframe: Week 12

    Proportion of participants with flare

    Timeframe: 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

    Timeframe: Week 12

    Proportion of participants who achieve Skin Pain NRS30 at Week 12 among participants with baseline Skin Pain NRS score ≥ 3.

    Timeframe: Week 12

    Proportion of participants with a ≥ 4-point increase from baseline in Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) score

    Timeframe: Week 12

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

    Timeframe: 54 weeks

    Mean change from baseline in abscess count

    Timeframe: 54 weeks

    Percentage change from baseline in abscess count

    Timeframe: 54 weeks

    Mean change from baseline in inflammatory nodule count

    Timeframe: 54 weeks

    Percentage change from baseline in inflammatory nodule count

    Timeframe: 54 weeks

    Mean change from baseline in draining tunnel count

    Timeframe: 54 weeks

    Percentage change from baseline in draining tunnel count

    Timeframe: 54 weeks

    Extension Period: Proportion of participants who achieve HiSCR

    Timeframe: Week 24

    Extension Period: Proportion of participants who achieve HiSCR75

    Timeframe: Week 24

    Extension Period: Proportion of participants with flare

    Timeframe: 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.

    Timeframe: Week 24

    Extension Period: Proportion of participants who achieve HiSCR

    Timeframe: Week 54

    Extension Period: Proportion of participants who achieve HiSCR75

    Timeframe: Week 54

    Extension Period: Proportion of participants with flare

    Timeframe: 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.

    Timeframe: Week 54

    Extension Period: Proportion of participants who achieve maintenance of HiSCR or greater response at each visit

    Timeframe: From Week 12 through Week 54

    Extension Period: Proportion of participants who achieve maintenance of HiSCR75 or greater response at each visit

    Timeframe: From Week 12 through Week 54