Acne Inversa

A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa

Incyte Study ID:
INCB 54707-312
CT.gov ID:
NCT06212999
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Recruiting
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Clinical Study Purpose

The purpose of this study is to evaluate long-term safety and efficacy of povorcitinib in participants with moderate to severe hidradenitis suppurativa who completed the 54 weeks of study treatment within the originating parent Phase 3 studies (INCB 54707-301 [NCT05620823] or INCB 54707-302 [NCT05620836]).

Clinical Study Summary

MEDICAL CONDITION(S)
  • Acne Inversa
    • PRODUCT
  • Drug: Povorcitinib
    • COLLABORATORS
    N/A
    DATE
    Jan 2024 - Dec 2026
    TYPE
    Interventional
    PHASE
    Phase 3
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Completion of the study treatment period of the originating parent study (INCB 54707-301 or INCB 54707-302).
    • Agreement to use contraception.

    Exclusion Criteria

    • Participation in the extension study could expose the participant to an undue safety risk.
    • Women who are pregnant (or who are considering pregnancy) or breastfeeding.

    Clinical Study Locations

    Location
    Status
    Location
    Investigative Site AT305
    WIEN, Austria, 01090
    Status
    Recruiting
    Location
    Investigative Site AT306
    INNSBRUCK, Austria, 06020
    Status
    Recruiting
    Location
    Investigative Site AU200
    LIVERPOOL, NSW, Australia, 02170
    Status
    Recruiting
    Location
    Investigative Site AU201
    CARLTON, VIC, Australia, 03053
    Status
    Not yet recruiting
    Location
    Investigative Site AU203
    KOTARA, NSW, Australia, 02289
    Status
    Recruiting
    Location
    Investigative Site AU204
    MELBOURNE, VIC, Australia, 03002
    Status
    Recruiting

    Protocol Summary

    Incyte Study ID:
    INCB 54707-312
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
    Interventions:
    Drug
    Enrollment:
    960
    Primary Outcome
    Open

    Proportion of participants with Treatment-Emergent Adverse Events (TEAEs)

    Timeframe: up to approximately 56 weeks

    Secondary Outcome
    Open

    Proportion of participants with Serious Treatment-Emergent Adverse Events (TEAEs)

    Timeframe: up to approximately 56 weeks

    Proportion of participants with TEAEs leading to study drug discontinuation

    Timeframe: up to approximately 56 weeks

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

    Timeframe: up to approximately 56 weeks

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

    Timeframe: up to approximately 56 weeks

    Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 90 (HiSCR90)

    Timeframe: up to approximately 56 weeks

    Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 100 (HiSCR100)

    Timeframe: up to approximately 56 weeks

    Proportion of participants with flare at each visit

    Timeframe: up to approximately 56 weeks

    Time to first flare

    Timeframe: up to approximately 56 weeks

    Mean change from baseline of parent study in Hidradenitis Suppurativa Quality of Life (HiSQoL) score at each visit

    Timeframe: up to approximately 56 weeks

    Mean change from baseline of parent study in Dermatology Life Quality Index (DLQI) score at each visit

    Timeframe: up to approximately 56 weeks

    Proportion of participants with no increase in abscess and inflammatory nodule (AN) count relative to Week 54 at each visit

    Timeframe: up to approximately 56 weeks

    Proportion of participants with no increase in abscess, inflammatory nodule, and draining tunnel (ANdT) count relative to Week 54 at each visit

    Timeframe: up to approximately 56 weeks

    Proportion of participants with no increase in draining tunnel count relative to Week 54 at each visit

    Timeframe: up to approximately 56 weeks

    Proportion of participants with a total AN count of 0, 1, or 2 at each visit

    Timeframe: up to approximately 56 weeks

    Proportion of participants with a total ANdT count of 0, 1, or 2 at each visit

    Timeframe: up to approximately 56 weeks