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

← catalyst calendar

NCT06527404

Sponsored by Amgen (industry) · AMGN — their whole pipeline →.

Phase
Phase 3
Status
Terminated
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
469actual
Sites
192
Countries
Argentina, Australia, Austria +27

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Why the sponsor stopped it

Sponsor Decision

As filed on the registry record, in the sponsor's own words.

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2024-07-18actualWhen the study began enrolling
Primary completion2026-04-17actualThe date the last participant is measured for the primary outcome — the readout window
Study completion2026-06-25actualThe whole study's end, after follow-up
First posted2024-07-30actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-07-27actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Prurigo Nodularis

Interventions

  • Drug: Rocatinlimab — also filed as AMG 451
  • Drug: Placebo

Primary outcomes

what the primary-completion date above is the date OF
Global: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 24
measured Up to 24 weeks
US Only: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score and Prurigo Nodularis Stage Assessment at Week 24
measured Up to 24 weeks

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