NCT06527404

A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 469 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The main objective of the study will be to evaluate the efficacy of rocatinlimab compared with placebo at week 24 on the patient-reported outcome (PRO) measure of pruritus and overall clinical assessment score (US only).

Conditions

• Prurigo Nodularis

Interventions

Type	Name	Description
DRUG	Rocatinlimab	SC Injection
DRUG	Placebo	SC Injection

Timeline

• Start date: 2024-07-18
• Primary completion: 2026-10-28
• Completion: 2027-01-17
• First posted: 2024-07-30
• Last updated: 2026-01-20

Locations

192 sites across 30 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Latvia, Mexico, Netherlands, Poland, Portugal, Romania, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study