臨床研究等提出・公開システム

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN2)

A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis

Ono Shintaro

Incyte Biosciences Japan G.K.

Tokyo Midtown Hibiya, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, Japan

jpmedinfo@incyte.com

Medical Information Center

Incyte Biosciences Japan G.K.

Tokyo Midtown Hibiya, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, Japan

+81-120-094-139

jpmedinfo@incyte.com

Recruiting

Mar. 15, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1. Male and female participants 18 to 75 years of age.
2. Clinical diagnosis of PN for at least 3 months prior to Screening visit.
3. Pruritus, defined as an average Itch NRS score >= 7 during the 7 days prior to Day 1/Baseline.
4. 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.
5. Documented history of treatment failure, demonstrated intolerance, or contraindication to a previous PN treatment.
6. Willingness to avoid pregnancy or fathering children.

1. Chronic pruritus due to a condition other than PN or neuropathic and psychogenic pruritus.
2. Diagnosis of PN secondary to medications.
3. Active AD lesions (signs and symptoms other than dry skin) within 3 months prior to Screening visit.
4. Women who are pregnant (or are considering pregnancy) or breastfeeding.
5. 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.
6. Evidence of infection with TB, HBV, HCV or HIV.
7. History of failure to any topical or systemic JAK or TYK2 inhibitor as treatment of PN or any inflammatory disease.
8. Laboratory values outside of the protocol-defined ranges.
Other protocol-defined Inclusion/Exclusion Criteria apply.

Both

Prurigo Nodularis

Experimental: Povorcitinib Dose 1
Povorcitinib at the protocol-defined dose.
Experimental: Povorcitinib Dose 2
Povorcitinib at the protocol-defined dose.
Placebo Comparator: Placebo
Placebo at the protocol-defined dose.

1. Proportion of participants achieving Itch NRS4 and IGA-CPG-S-TS at Week 24
[Time Frame: Week 24]

1. Proportion of participants achieving Itch NRS4 at Week 24
[Time Frame: Week 24]
2. Proportion of participants achieving IGA-CPG-S-TS at Week 24
[Time Frame: Week 24]
3. Proportion of participants achieving Itch NRS4 at Week 4
[Time Frame: Week 4]
4. Time to Itch NRS4
[Time Frame: Up to 52 Weeks]
5. Change from baseline in Itch NRS score at each postbaseline visit
[Time Frame: Up to 52 weeks]
6. Percent change from baseline in NRS score at each postbaseline visit
[Time Frame: Up to 52 weeks]
7. Proportion of participants achieving Itch NRS4 at each postbaseline visit
[Time Frame: Up to 52 weeks]
8. Proportion of participants achieving IGA-CPG-S-TS at each postbaseline visit
[Time Frame: Up to 52 weeks]
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]
10. Proportion of participants achieving >= 75% healed lesions in Prurigo Activity Score (PAS) at each postbaseline visit
[Time Frame: Up to 52 weeks]
11. Proportion of participants achieving Itch NRS4 and IGA-CPG-S-TS at each postbaseline visit
[Time Frame: Up to 52 weeks]
12. Change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit.
[Time Frame: Up to 52 weeks]
13. Percent change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit.
[Time Frame: Up to 52 weeks]
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]
15. Change from baseline in Skin Pain NRS score at each postbaseline visit
[Time Frame: Up to 52 weeks]
16. Percent change from baseline in Skin Pain NRS score at each postbaseline visit
[Time Frame: Up to 52 weeks]
17. Change from baseline in the Hospital Anxiety and Depression Scale (HADS) score at each postbasline visit
[Time Frame: Up to 52 weeks]
18. Percent change from baseline in the HADS score at each postbaseline visit
[Time Frame: Up to 52 weeks]
19. Change from baseline in EQ-5D-5L score at each postbaseline visit
[Time Frame: Up to 52 weeks]
20. Percent change from baseline in EQ-5D-5L score at each postbaseline visit
[Time Frame: Up to 52 weeks]
21. Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) score at each postbaseline visit
[Time Frame: Up to 52 weeks]
22. Percent change in FACIT-F score at each postbaseline visit
[Time Frame: Up to 52 weeks]
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]
24. Number of Participants with Treatment Emergent Adverse Events (TEAE)
[Time Frame: Up to 52 weeks]

+81-48-222-5015

Dec. 20, 2024

Yes

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

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