Prurigo nodularis

A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN1)

Incyte Study ID:
INCB54707-305
CT.gov ID:
NCT06516952
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 effect of povorcitinib on itch and

skin lesions in participants with prurigo nodularis.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Prurigo nodularis
    • PRODUCT
  • Drug: Povorcitinib
  • Drug: Placebo
    • COLLABORATORS
    N/A
    DATE
    Oct 2024 - Oct 2026
    TYPE
    Interventional
    PHASE
    Phase 3
    SEX
    Female & Male
    AGE
    18 - 75 Years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Male and female participants 18 to 75 years of age.
    • Clinical diagnosis of PN for at least 3 months prior to Screening visit.

    Exclusion Criteria

    • Chronic pruritus due to a condition other than PN or neuropathic and psychogenic pruritus.
    • Diagnosis of PN secondary to medications.

    Clinical Study Locations

    Location
    Status
    Location
    DERMEDIC JACEK ZDYBSKI
    OSTROWIEC SWIETOKRZYSKI, Poland, 27-400
    Status
    Not yet recruiting
    Location
    CITYCLINIC PRZYCHODNIA LEKARSKO-PSYCHOLOGICZNA MATUSIAK SPOLKA PARTNERSKA
    WROCLAW, Poland, 50566
    Status
    Not yet recruiting
    Location
    DERMEFFECTS
    LONDON, ON, Canada, N6H 5L5
    Status
    Not yet recruiting
    Location
    AACHEN UNIVERSITY HOSPITAL
    AACHEN, Germany, 52074
    Status
    Not yet recruiting
    Location
    PANSTWOWY INSTYTUT MEDYCZNY MSWIA
    WARSZAWA, Poland, 02-507
    Status
    Not yet recruiting
    Location
    UNIVERSITAETSMEDIZIN GOETTINGEN
    GOTTINGEN, Germany, 37075
    Status
    Not yet recruiting

    Protocol Summary

    Incyte Study ID:
    INCB54707-305
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
    Interventions:
    Drug
    Enrollment:
    330
    Primary Outcome
    Open

    Proportion of participants achieving Itch NRS4 and IGA-CPG-S-TS at Week 24

    Timeframe: Week 24

    Secondary Outcome
    Open

    Proportion of participants achieving Itch NRS4 at Week 24

    Timeframe: Week 24

    Proportion of participants achieving IGA-CPG-S-TS at Week 24

    Timeframe: Week 24

    Proportion of participants achieving Itch NRS4 at Week 4

    Timeframe: Week 4

    Time to Itch NRS4

    Timeframe: Up to 52 weeks

    Change from baseline in Itch NRS score at each postbaseline visit

    Timeframe: Up to 52 weeks

    Percent change from baseline in NRS score at each postbaseline visit

    Timeframe: Up to 52 weeks

    Proportion of participants achieving Itch NRS4 at each postbaseline visit

    Timeframe: Up to 52 weeks

    Proportion of participants achieving IGA-CPG-S-TS at each postbaseline visit

    Timeframe: Up to 52 weeks

    Proportion of participants achieving Investigator's Global Assessment – Chronic Prurigo Activity (IGA-CPG-A) at each postbaseline visit

    Timeframe: Up to 52 weeks

    Proportion of participants achieving ≥ 75% healed lesions in Prurigo Activity Score (PAS) at each postbaseline visit

    Timeframe: Up to 52 weeks

    Proportion of participants achieving Itch NRS4 and IGA-CPG-S-TS at each postbaseline visit

    Timeframe: Up to 52 weeks

    Change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit.

    Timeframe: Up to 52 weeks

    Percent change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit.

    Timeframe: Up to 52 weeks

    Proportion of participants with at least a 4-point decrease in DLQI score from baseline at each postbaseline visit for participants with DLQI score ≥ 4 at baseline

    Timeframe: Up to 52 weeks

    Change from baseline in Skin Pain NRS score at each postbaseline visit

    Timeframe: Up to 52 weeks

    Percent change from baseline in Skin Pain NRS score at each postbaseline visit

    Timeframe: Up to 52 weeks

    Change from baseline in the Hospital Anxiety and Depression Scale (HADS) score at each postbasline visit

    Timeframe: Up to 52 weeks

    Percent change from baseline in the HADS score at each postbaseline visit

    Timeframe: Up to 52 weeks

    Change from baseline in EQ-5D-5L score at each postbaseline visit

    Timeframe: Up to 52 weeks

    Percent change from baseline in EQ-5D-5L score at each postbaseline visit

    Timeframe: Up to 52 weeks

    Change in Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) score at each postbaseline visit

    Timeframe: Up to 52 weeks

    Percent change in FACIT-F score at each postbaseline visit

    Timeframe: Up to 52 weeks

    Proportion of participants with at least a ≥ 4-point increase in FACIT-F score at each postbaseline visit for participants with FACIT-F score ≤ 48 at baseline

    Timeframe: Up to 52 weeks

    Number of Participants with Treatment Emergent Adverse Events (TEAE)

    Timeframe: Up to 52 weeks