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NCT06527404Phase 3ACTIVE NOT RECRUITING

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

Study 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 / Drugs
RocatinlimabPlacebo
View on ClinicalTrials.gov ↗
Sponsor
AMGN
Amgen Inc
Biologics
F35/100
Study Details
Enrollment469 participants
Primary Completion—
Lead SponsorAmgen
Data Retrieved2026-04-13 18:29:34.157204+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.

Status & Expected Data

Enrollment is complete. The trial is in its follow-up or data collection phase — a readout may occur on or near the primary completion date.

Enrolled: 469 participants
Sponsor Catalyst Profile

Amgen Inc (AMGN) is the sponsoring company for this trial. BiotechSign currently grades this company F (35/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

AMGN Full Pipeline →All Companies →
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