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Evaluating the effects of povorcitinib on prurigo nodularis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis

Phase 3 Interventional Incyte Corporation · NCT06516965

This study is testing if a new medication called povorcitinib can help people with prurigo nodularis feel less itchy and improve their skin lesions.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment330 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorIncyte Corporation Industry-sponsored
Drugs / interventionspovorcitinib
Locations135 sites (Phoenix, Arizona and 134 other locations)
Trial IDNCT06516965 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of povorcitinib in treating participants with prurigo nodularis, a condition characterized by intense itching and skin lesions. Participants will receive either the active drug or a placebo to determine the impact on their symptoms. The study will include individuals aged 18 to 75 who have experienced prurigo nodularis for at least three months and have a significant itch score. The primary focus is on reducing itch and improving skin lesions associated with this chronic condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a clinical diagnosis of prurigo nodularis and severe itching.

Not a fit: Patients with chronic pruritus from conditions other than prurigo nodularis or those with secondary prurigo nodularis due to medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate the symptoms of prurigo nodularis, improving the quality of life for affected patients.

How similar studies have performed: Previous studies have shown promise in treating prurigo nodularis with similar approaches, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Phoenix, Arizona and 134 other locations

+85 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Prurigo NodularisPrurigo nodularisPNINCB054707chronic pruritus
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.