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A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)

NCT05651711 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 726

Last updated 2025-04-03

No results posted yet for this study

Summary

The co-primary objectives of the study are to:

* Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD).
* Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Eczema Area and Severity Index (EASI).

Conditions

Interventions

DRUG

Rocatinlimab

Rocatinlimab will be administered through a subcutaneous (SC) injection.

OTHER

Placebo

The matching placebo will be administered through a SC injection.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-14
Primary Completion
2024-06-05
Completion
2024-08-27
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • Germany
  • Japan
  • Mexico
  • Poland
  • Portugal
  • Romania
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05651711 on ClinicalTrials.gov