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ICP-332 in Prurigo Nodularis
NCT07236099Phase 2
Key facts
- Status
- Recruiting
- Start
- Nov 2025
- Primary completion
- Mar 2027
- Countries
- 5
- Sponsor
- InnoCare Pharma
- Modality
- Small Molecules
- Drugs
- soficitinib
- Conditions
- prurigo nodularis (PN)
01
Overview
Phase 2, randomised, double-blind trial of soficitinib in prurigo nodularis (PN) (3 arms), sponsored by InnoCare Pharma. Primary endpoint: Peak Pruritus Numeric Rating Scale at 16 weeks. Started Nov 2025; status: recruiting.
02
Design
3 arms- Study design
- RandomizedDouble-blind
ICP-332 80mg
Experimental: ICP-332 80mg Tablets
ICP-332 120mg
Experimental: ICP-332 120mg Tablets
Placebo
Placebo Comparator: Placebo Tablets
03
Who it enrols
Adults aged 18-75 with a clinical diagnosis of Prurigo Nodularis for at least 3 months, with at least 20 pruriginous lesions, severe itch (PP NRS >= 7), and inadequate response to topical corticosteroids. Excludes patients with moderate to severe atopic dermatitis or other skin morbidities.
04
Endpoints
Primary
Peak Pruritus Numeric Rating Scale
Secondary
Peak Pruritus Numeric Rating Scale
Investigator's Global Assessment for Chronic Prurigo Stage
Dermatology Life Quality Index
Treatment-Emergent Adverse Events
Maximum concentration
Area Under Concentration Versus Time Curve
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