A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN2)

Phase 3RecruitingNCT06516965

Incyte Corporation330 enrolled

Overview

The purpose of this study is to evaluate effect of povorcitinib on itch and skin lesions in participants with prurigo nodularis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

330

Conditions

Prurigo Nodularis

Interventions

PovorcitinibDRUG

Oral Tablet

PlaceboDRUG

Oral Tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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. * Pruritus, defined as an average Itch NRS score ≥ 7 during the 7 days prior to Day 1/Baseline. * Total of ≥ 20 pruriginous lesions on ≥ 2 different body regions (both legs, and/or both arms, and/or trunk) at Screening and Day 1/Baseline. * Documented history of treatment failure, demonstrated intolerance, or contraindication to a previous PN treatment. * Willingness to avoid pregnancy or fathering children. Exclusion Criteria: * Chronic pruritus due to a condition other than PN or neuropathic and psychogenic pruritus. * Diagnosis of PN secondary to medications. * Active AD lesions (signs and symptoms other than dry skin) within 3 months prior to Screening visit. * Women who are pregnant (or are considering pregnancy) or breastfeeding. * Medical history including thrombocytopenia, coagulopathy or platelet dysfunction; venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, stroke, moderate to severe heart failure, cerebrovascular accident, myocardial infarction, or other significant cardiovascular diseases; Q-wave interval abnormalities; disseminated herpes zoster or dermatomal herpes zoster; disseminated herpes simplex; chronic/recurrent infections; malignancies. * Evidence of infection with TB, HBV, HCV or HIV. * History of failure to any topical or systemic JAK or TYK2 inhibitor as treatment of PN or any inflammatory disease. * Laboratory values outside of the protocol-defined ranges. Other protocol-defined Inclusion/Exclusion Criteria apply.

Locations (120)

Outcomes

Primary Outcomes

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

Defined as proportion of participants achieving a ≥ 4-point improvement \[reduction\] in Itch NRS score from baseline (Itch NRS4) and an IGA CPG-S score of 0 or 1 with a ≥ 2-grade improvement from baseline (IGA-CPG-S-TS).

Time frame: Week 24

Secondary Outcomes

Proportion of participants achieving Itch NRS4 at Week 24

Defined as percentage of participants that achieve a ≥ 4-point improvement (reduction) in Itch NRS score from baseline.

Time frame: Week 24

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

Defined as percentage of participants that achieve IGA-CPG-S score of 0 or 1 with a ≥ 2 grade improvement from baseline.

Time frame: Week 24

Proportion of participants achieving Itch NRS4 at Week 4

Defined as percentage of participants that achieve a ≥ 4-point improvement (reduction) in Itch NRS score from baseline.

Time frame: Week 4

Time to Itch NRS4

Defined as time taken for the participant to achieve a ≥4 improvement in Itch NRS score from baseline.

Time frame: Up to 52 Weeks

Change from baseline in Itch NRS score at each postbaseline visit

Itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable".

Time frame: Up to 52 weeks

Percent change from baseline in NRS score at each postbaseline visit

Central Contacts

Incyte Corporation Call Center (US)

CONTACT

1.855.463.3463 medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

CONTACT

+800 00027423 eumedinfo@incyte.com

Data from ClinicalTrials.gov

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Medical Dermatology Specialists Phoenix

Phoenix, Arizona, United States

RECRUITING

Investigate Md

Scottsdale, Arizona, United States

COMPLETED

First Oc Dermatology Research Inc

Fountain Valley, California, United States

RECRUITING

Clinical Science Institute Clinical Research Specialists Inc

Santa Monica, California, United States

RECRUITING

Center For Clinical and Cosmetic Research

Aventura, Florida, United States

COMPLETED

Clearlyderm Dermatology

Boca Raton, Florida, United States

RECRUITING

Direct Helpers Research Center

Hialeah, Florida, United States

RECRUITING

Skin Care Research, Llc

Hollywood, Florida, United States

RECRUITING

Ziaderm Research, Llc

Miami, Florida, United States

RECRUITING

Nodal Medical Center, Llc

Tampa, Florida, United States

RECRUITING

...and 110 more locations

Time frame: Up to 52 weeks

Proportion of participants achieving Itch NRS4 at each postbaseline visit

Defined as percentage of participants that achieve a ≥ 4-point improvement in Itch NRS score from baseline.

Time frame: Up to 52 weeks

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

Defined as percentage of participants that achieve an IGA-CPG-S score of 0 or 1 with a ≥ 2 grade improvement from baseline.

Time frame: Up to 52 weeks

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

Defined as percentage of participants that achieve an IGA-CPG-A score of 0 or 1 with a ≥ 2 grade improvement (reduction) from baseline.

Time frame: Up to 52 weeks

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

The modified PAS will be used in this study as defined by the protocol.

Time frame: Up to 52 weeks

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

Defined as percentage of participants that achieve a ≥ 4-point improvement (reduction) in Itch NRS score and IGA-CPG-S score of 0 or 1 with a ≥ 2-grade improvement from baseline.

Time frame: Up to 52 weeks

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

The DLQI is a simple, 10-question validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days.

Time frame: Up to 52 weeks

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

The DLQI is a simple, 10-question validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days.

Time frame: 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

Defined as percentage 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.

Time frame: Up to 52 weeks

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

Skin Pain NRS is an 11-point scale (0 to10) where 0 is "no pain" and 10 is the "worst pain imaginable".

Time frame: Up to 52 weeks

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

Skin Pain NRS is an 11-point scale (0 to10) where 0 is "no pain" and 10 is the "worst pain imaginable".

Time frame: Up to 52 weeks

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

HADS is a 14-item questionnaire that assesses the levels of anxiety and depression that a participant is currently experiencing. There are 7 questions each for measuring anxiety and for measuring depression, with 4 possible responses to each question (responses are scored as 0, 1, 2, or 3).

Time frame: Up to 52 weeks

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

Time frame: Up to 52 weeks

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

The EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcome.

Time frame: Up to 52 weeks

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

The EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcome.

Time frame: Up to 52 weeks

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

The FACIT-F is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days.

Time frame: Up to 52 weeks

Percent change in FACIT-F score at each postbaseline visit

The FACIT-F is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days.

Time frame: 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

The FACIT-F is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days.

Time frame: Up to 52 weeks

Number of Participants with Treatment Emergent Adverse Events (TEAE)

Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.

Time frame: Up to 52 weeks