A Phase 3, 52-Week, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab in Adult Subjects With Prurigo Nodularis Who are Inadequately Controlled on Topical Therapies or Not Eligible for Topical Therapies

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-510753-10-00

Acronym

20230053

Enrollment

183

Registered

2024-10-11

Start date

2024-11-01

Completion date

Unknown

Last updated

2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prurigo Nodularis

Brief summary

Achieving reduction from baseline in weekly average of daily itching score at specified time points.

Detailed description

Improvement in investigator assessment of PN lesions, Improvement in daily itching from baseline., Improvement in daily skin pain from baseline, Change in quality of life from baseline., Change in sleep disturbance from baseline, Treatment-emergent adverse events , adverse events of special interest, and serious adverse events

Interventions

DRUGRocatinlimab

DRUGPlacebo for AMG 451

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Achieving reduction from baseline in weekly average of daily itching score at specified time points.	—

Secondary

Measure	Time frame
Improvement in investigator assessment of PN lesions, Improvement in daily itching from baseline., Improvement in daily skin pain from baseline, Change in quality of life from baseline., Change in sleep disturbance from baseline, Treatment-emergent adverse events , adverse events of special interest, and serious adverse events	—

Countries

Austria, Belgium, Finland, France, Germany, Greece, Hungary, Italy, Latvia, Netherlands, Poland, Portugal, Romania, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026