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A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)

NCT05724199 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 746

Last updated 2025-11-24

No results posted yet for this study

Summary

The coprimary objectives of the study are to:

* evaluate the efficacy of rocatinlimab in combination with topical corticosteroid and/or topical calcineurin inhibitor (TCS/TCI), compared with placebo in combination with TCS/TCI at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™).
* evaluate the efficacy of rocatinlimab, in combination with TCS/TCI, compared with placebo in combination with TCS/TCI at Week 24, assessed using Eczema Area and Severity Index (EASI).

Conditions

Interventions

DRUG

Rocatinlimab

Subcutaneous (SC) injection

OTHER

Placebo

SC injection

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2023-02-21
Primary Completion
2024-09-15
Completion
2024-12-04
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • China
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Japan
  • Malaysia
  • Netherlands
  • Poland
  • Puerto Rico
  • Romania
  • Singapore
  • Slovakia
  • Slovenia
  • Spain
  • Switzerland
  • 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 NCT05724199 on ClinicalTrials.gov