A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)

NCT05398445 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 769

Last updated 2025-11-24

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy treatment.

Conditions

Interventions

DRUG

Rocatinlimab

Participants will receive Rocatinlimab subcutaneously.

DRUG

Placebo

Participants will receive a placebo subcutaneously.

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
2022-05-31
Primary Completion
2024-11-28
Completion
2025-01-13
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • China
  • Croatia
  • Czechia
  • Germany
  • Greece
  • Hungary
  • Italy
  • Japan
  • Latvia
  • Netherlands
  • Poland
  • Portugal
  • Puerto Rico
  • Slovakia
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

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 NCT05398445 on ClinicalTrials.gov