Acne Inversa

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

Incyte Study ID:
INCB 54707-301
CT.gov ID:
NCT05620823
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Recruitment Complete
Subscribe to UpdatesContact Us

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
    Dec 2022 - Feb 2025
    TYPE
    Interventional
    PHASE
    Phase 3
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Location
    Status
    Location
    Investigative Site AT301
    WIEN, Austria, 01100
    Status
    Recruiting
    Location
    Investigative Site AT302
    LINZ, Austria, 04020
    Status
    Recruiting
    Location
    Investigative Site BE301
    GHENT, Belgium, 09000
    Status
    Recruiting
    Location
    Investigative Site BE302
    LIEGE, Belgium, 04000
    Status
    Recruiting
    Location
    Investigative Site BE303
    NAMUR, Belgium, 05000
    Status
    Completed
    Location
    Investigative Site BE304
    BRUSSELS, Belgium, 01200
    Status
    Recruiting

    Key Inclusion and Exclusion Criteria

    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

    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.

    Protocol Summary

    Incyte Study ID:
    INCB 54707-301
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
    Interventions:
    Drug
    Enrollment:
    608
    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 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 at each visit

    Timeframe: 54 weeks

    Mean change from baseline in abscess count at each visit.

    Timeframe: 54 weeks

    Percentage change from baseline in abscess count at every visit

    Timeframe: 54 weeks

    Mean change from baseline in inflammatory nodule count at each visit

    Timeframe: 54 weeks

    Percentage change from baseline in inflammatory nodule count at each visit.

    Timeframe: 54 weeks

    Mean change from baseline in draining tunnel count at each visit.

    Timeframe: 54 weeks

    Percentage change from baseline in draining tunnel count at each visit.

    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