A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN2)
- Registration Number
- NCT06516965
- Lead Sponsor
- Incyte Corporation
- Brief Summary
The purpose of this study is to evaluate effect of povorcitinib on itch and skin lesions in participants with prurigo nodularis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 330
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Povorcitinib Dose 1 Povorcitinib Povorcitinib at the protocol-defined dose. Placebo Placebo Placebo at the protocol-defined dose. Povorcitinib Dose 2 Povorcitinib Povorcitinib at the protocol-defined dose.
- Primary Outcome Measures
Name Time Method Proportion of participants achieving Itch NRS4 and IGA-CPG-S-TS at Week 24 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).
- Secondary Outcome Measures
Name Time Method Proportion of participants achieving ≥ 75% healed lesions in Prurigo Activity Score (PAS) at each postbaseline visit Up to 52 weeks The modified PAS will be used in this study as defined by the protocol.
Proportion of participants achieving IGA-CPG-S-TS at Week 24 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 to Itch NRS4 Up to 52 Weeks Defined as time taken for the participant to achieve a ≥4 improvement in Itch NRS score from baseline.
Change from baseline in Itch NRS score at each postbaseline visit Up to 52 weeks 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".
Proportion of participants achieving Investigator's Global Assessment - Chronic Prurigo Activity (IGA-CPG-A) at each postbaseline visit Up to 52 weeks Defined as percentage of participants that achieve an IGA-CPG-A score of 0 or 1 with a ≥ 2 grade improvement (reduction) from baseline.
Proportion of participants achieving Itch NRS4 at Week 24 Week 24 Defined as percentage of participants that achieve a ≥ 4-point improvement (reduction) in Itch NRS score from baseline.
Change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit. Up to 52 weeks 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.
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 Up to 52 weeks 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.
Proportion of participants achieving Itch NRS4 at Week 4 Week 4 Defined as percentage of participants that achieve a ≥ 4-point improvement (reduction) in Itch NRS score from baseline.
Proportion of participants achieving Itch NRS4 and IGA-CPG-S-TS at each postbaseline visit Up to 52 weeks 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.
Percent change from baseline in NRS score at each postbaseline visit Up to 52 weeks 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".
Proportion of participants achieving Itch NRS4 at each postbaseline visit Up to 52 weeks Defined as percentage of participants that achieve a ≥ 4-point improvement in Itch NRS score from baseline.
Proportion of participants achieving IGA-CPG-S-TS at each postbaseline visit Up to 52 weeks Defined as percentage of participants that achieve an IGA-CPG-S score of 0 or 1 with a ≥ 2 grade improvement from baseline.
Change from baseline in Skin Pain NRS score at each postbaseline visit Up to 52 weeks Skin Pain NRS is an 11-point scale (0 to10) where 0 is "no pain" and 10 is the "worst pain imaginable".
Percent change from baseline in Skin Pain NRS score at each postbaseline visit Up to 52 weeks Skin Pain NRS is an 11-point scale (0 to10) where 0 is "no pain" and 10 is the "worst pain imaginable".
Percent change from baseline in the HADS score at each postbaseline visit Up to 52 weeks 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).
Percent change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit. Up to 52 weeks 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.
Change from baseline in the Hospital Anxiety and Depression Scale (HADS) score at each postbasline visit Up to 52 weeks 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).
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 Up to 52 weeks 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.
Number of Participants with Treatment Emergent Adverse Events (TEAE) Up to 52 weeks Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Percent change from baseline in EQ-5D-5L score at each postbaseline visit Up to 52 weeks The EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcome.
Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) score at each postbaseline visit Up to 52 weeks 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.
Change from baseline in EQ-5D-5L score at each postbaseline visit Up to 52 weeks The EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcome.
Percent change in FACIT-F score at each postbaseline visit Up to 52 weeks 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.
Trial Locations
- Locations (136)
Chicago Cosmetic Surgery and Dermatology
🇺🇸Chicago, Illinois, United States
Dermatology Specialists Research Indiana
🇺🇸Clarksville, Indiana, United States
Southern Indiana Clinical Trials
🇺🇸New Albany, Indiana, United States
Dermatology Specialists Research
🇺🇸Louisville, Kentucky, United States
University of Maryland School of Medicine
🇺🇸Baltimore, Maryland, United States
Dermatology Associates Pc
🇺🇸Rockville, Maryland, United States
Metro Boston Clinical Partners
🇺🇸Brighton, Massachusetts, United States
Fivenson Dermatology
🇺🇸Ann Arbor, Michigan, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Hamzavi Dermatology
🇺🇸Fort Gratiot, Michigan, United States
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