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

Prurigo Nodularis

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

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Participation Requirements

  • Sex:

    ALL
  • Eligible Ages:

    18 to 75

Participation 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.
* 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.

Study Location

Dermeffects
Dermeffects
London, Ontario
Canada

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Skinsense Medical Research
Skinsense Medical Research
Saskatoon, Saskatchewan
Canada

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Simcoderm Medical and Surgical Dermatology Centre
Simcoderm Medical and Surgical Dermatology Centre
Barrie, Ontario
Canada

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Centre de Recherche Saint-Louis
Centre de Recherche Saint-Louis
Quebec City, Quebec
Canada

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Skin Physicians
Skin Physicians
Edmonton, Alberta
Canada

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North York Research Inc.
North York Research Inc.
Toronto, Ontario
Canada

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Alpha Research-Lucere Dermatology and Laser Clinic
Alpha Research-Lucere Dermatology and Laser Clinic
Edmonton, Alberta
Canada

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Toronto Research Centre
Toronto Research Centre
Toronto, Ontario
Canada

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Study Sponsored By
Incyte Corporation
Participants Required
More Information
Study ID: NCT06516965