Prurigo Nodularis
Conditions
Keywords
Prurigo nodularis, PN, INCB054707, chronic pruritus
Brief summary
The purpose of this study is to evaluate effect of povorcitinib on itch and skin lesions in participants with prurigo nodularis.
Interventions
DRUGPovorcitinib
Oral Tablet
DRUGPlacebo
Oral Tablet
Sponsors
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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". |
| 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. |
| 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 ≥ 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 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. |
| 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. |
| 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. |
| 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. |
| 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". |
| 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). |
| 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). |
| 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 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. |
| 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. |
| 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. |
Countries
Argentina, Austria, Bulgaria, Canada, France, Germany, Italy, Netherlands, Poland, South Korea, Switzerland, United States
Contacts
STUDY_DIRECTORIncyte Medical Monitor
Incyte Corporation
Outcome results
None listed