Status:
RECRUITING
A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN1)
Lead Sponsor:
Incyte Corporation
Conditions:
Prurigo Nodularis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate effect of povorcitinib on itch and skin lesions in participants with prurigo nodularis.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 3 2027
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT06516952
Start Date
October 10 2024
End Date
May 3 2027
Last Update
December 31 2025
Active Locations (120)
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1
Cahaba Dermatology
Birmingham, Alabama, United States, 35244
2
Banner - University Medicine Multispecialty Services Clinic
Tucson, Arizona, United States, 85718
3
Premier Dermatology Clinical Trials Institute At Northwest Arkansas
Fayetteville, Arkansas, United States, 72703
4
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913