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NCT Number: NCT06516965

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Prurigo Nodularis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novatrials, Charlestown, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Povorcitinib

Drug

Oral Tablet

Other names: INCB054707

Placebo

Drug

Oral Tablet

Primary outcomes

  1. Proportion of participants achieving Itch NRS4 and IGA-CPG-S-TS at Week 24

    Time frame: 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 outcomes

  1. Proportion of participants achieving Itch NRS4 at Week 24

    Time frame: Week 24

    Defined as percentage of participants that achieve a ≥ 4-point improvement (reduction) in Itch NRS score from baseline.

  2. Proportion of participants achieving IGA-CPG-S-TS at Week 24

    Time frame: Week 24

    Defined as percentage of participants that achieve IGA-CPG-S score of 0 or 1 with a ≥ 2 grade improvement from baseline.

  3. Proportion of participants achieving Itch NRS4 at Week 4

    Time frame: Week 4

    Defined as percentage of participants that achieve a ≥ 4-point improvement (reduction) in Itch NRS score from baseline.

  4. Time to Itch NRS4

    Time frame: Up to 52 Weeks

    Defined as time taken for the participant to achieve a ≥4 improvement in Itch NRS score from baseline.

  5. Change from baseline in Itch NRS score at each postbaseline visit

    Time frame: 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".

  6. Percent change from baseline in NRS score at each postbaseline visit

    Time frame: 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".

  7. Proportion of participants achieving Itch NRS4 at each postbaseline visit

    Time frame: Up to 52 weeks

    Defined as percentage of participants that achieve a ≥ 4-point improvement in Itch NRS score from baseline.

  8. Proportion of participants achieving IGA-CPG-S-TS at each postbaseline visit

    Time frame: 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.

  9. Proportion of participants achieving Investigator's Global Assessment - Chronic Prurigo Activity (IGA-CPG-A) at each postbaseline visit

    Time frame: 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.

  10. Proportion of participants achieving ≥ 75% healed lesions in Prurigo Activity Score (PAS) at each postbaseline visit

    Time frame: Up to 52 weeks

    The modified PAS will be used in this study as defined by the protocol.

  11. Proportion of participants achieving Itch NRS4 and IGA-CPG-S-TS at each postbaseline visit

    Time frame: 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.

  12. Change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit.

    Time frame: 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.

  13. Percent change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit.

    Time frame: 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.

  14. 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

    Time frame: 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.

  15. Change from baseline in Skin Pain NRS score at each postbaseline visit

    Time frame: 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".

  16. Percent change from baseline in Skin Pain NRS score at each postbaseline visit

    Time frame: 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".

  17. Change from baseline in the Hospital Anxiety and Depression Scale (HADS) score at each postbasline visit

    Time frame: 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).

  18. Percent change from baseline in the HADS score at each postbaseline visit

    Time frame: 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).

  19. Change from baseline in EQ-5D-5L score at each postbaseline visit

    Time frame: Up to 52 weeks

    The EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcome.

  20. Percent change from baseline in EQ-5D-5L score at each postbaseline visit

    Time frame: Up to 52 weeks

    The EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcome.

  21. Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) score at each postbaseline visit

    Time frame: 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.

  22. Percent change in FACIT-F score at each postbaseline visit

    Time frame: 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.

  23. 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

    Time frame: 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.

  24. Number of Participants with Treatment Emergent Adverse Events (TEAE)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 24, 2024
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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