A Study With Self-administered Rocatinlimab in Adolescent and Adult Participants With Moderate-to-severe Atopic Dermatitis

NCT06224192 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: 20230180
• Study Type: interventional
• Target: 151
• Locations: 4 countries
• Sites: 47

Brief Summary

The primary objective of this study is to assess successful self-administration of rocatinlimab subcutaneously using devices for injection.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Proportion of Full-dose Self-administered Rocatinlimab Injections Among Total Attempted Injections up to Week 16

  Up to Week 16

Secondary Outcomes (1)

• Proportion of Devices that Have Been Reported with Product Complaints Related to Function by Participants, Caregivers, or Investigators Among Total Dispensed Devices up to Week 16

  Up to Week 16

Study Arms (3)

Rocatinlimab Dose 1 Prefilled Syringe (PFS)

EXPERIMENTAL

Rocatinlimab will be self-administered subcutaneously using a PFS. Participants will receive rocatinlimab for 52 weeks.

Combination Product: Rocatinlimab Prefilled Syringe

Rocatinlimab Dose 2 PFS

EXPERIMENTAL

Rocatinlimab will be self-administered subcutaneously using a PFS. Participants will receive rocatinlimab for 52 weeks.

Combination Product: Rocatinlimab Prefilled Syringe

Rocatinlimab Dose 2 Autoinjector (AI)

EXPERIMENTAL

Rocatinlimab will be self-administered subcutaneously using an AI. Participants will received rocatinlimab for 52 weeks.

Combination Product: Rocatinlimab AI

Interventions

Rocatinlimab Prefilled Syringe COMBINATION_PRODUCT

Prefilled Syringe (PFS) for subcutaneous (SC) injection self-administration of rocatinlimab.

Also known as: AMG 451

Rocatinlimab Dose 1 Prefilled Syringe (PFS); Rocatinlimab Dose 2 PFS

Rocatinlimab AI COMBINATION_PRODUCT

AI for SC injection self-administration of rocatinlimab.

Also known as: AMG 451

Rocatinlimab Dose 2 Autoinjector (AI)

Eligibility Criteria

• Age: 12 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 12 at Day 1.
• Diagnosis of AD according to American Academy of Dermatology (AAD) Consensus Criteria (2014) that has been present for at least 12 months.
• History of inadequate response to Topical Corticosteroids (TCS) of medium to higher potency (with or without topical calcineurin inhibitors \[TCI\]).
• Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) score ≥ 3 at screening and pre-randomization.
• Eczema Area and Severity Index (EASI) score ≥ 16 at initial at screening and pre-randomization.
• ≥ 10% body surface area (BSA) of AD involvement at screening and pre-randomization.

You may not qualify if:

• Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to day 1 pre-randomization.
• Treatment with any of the following medications or therapies within 5 half-lives prior to day 1 pre-randomization:
• Systemic corticosteroids
• Non-biologic, non-targeted systemic immunosuppressants
• Oral or Topical Janus kinase inhibitors
• Treatment with any of the following medications or therapies within 1 week before day 1 pre-randomization:
• Topical phosphodiesterase 4 (PDE4) inhibitors
• Other topical immunosuppressive agents (not including TCS/TCI)
• Combination topical agents containing any of the above components

Sponsors & Collaborators

• Amgen: lead

Study Sites (47)

Kern Research Inc

Bakersfield, California, 93301, United States

Location

Long Beach Research Institute

Long Beach, California, 90805, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Havana Research Institute Inc

Pasadena, California, 91105, United States

Location

Integrative Skin Science and Research

Sacramento, California, 95815, United States

Location

Direct Helpers Research Center

Hialeah, Florida, 33012, United States

Location

Anchor Medical Research

Miami, Florida, 33176, United States

Location

Hamilton Research, LLC

Alpharetta, Georgia, 30022, United States

Location

Treasure Valley Medical Research

Boise, Idaho, 83706, United States

Location

Dermatology and Skin Cancer Center Leawood

Leawood, Kansas, 66211, United States

Location

Excel Clinical Research

Las Vegas, Nevada, 89109, United States

Location

Las Vegas Clinical Trials

North Las Vegas, Nevada, 89030, United States

Location

Skin Cancer and Dermatology Institute

Reno, Nevada, 89509, United States

Location

The Skin Surgery Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Bexley Dermatology Research

Bexley, Ohio, 43209, United States

Location

Apex Clinical Research Center LLC

Mayfield Heights, Ohio, 44124, United States

Location

Essential Medical Research LLC

Tulsa, Oklahoma, 74137, United States

Location

Health Concepts

Rapid City, South Dakota, 57702, United States

Location

Cumberland Skin Center

Hermitage, Tennessee, 37076, United States

Location

Sms Clinical Research Limited Liability Company

Mesquite, Texas, 75149, United States

Location

Texas Dermatology Research Center

Plano, Texas, 75025, United States

Location

Virginia Dermatology and Skin Cancer Center

Norfolk, Virginia, 23502, United States

Location

Interior Dermatology Centre

Kelowna, British Columbia, V1W 4V5, Canada

Location

LEADER Research

Hamilton, Ontario, L8L 3C3, Canada

Location

Lynderm Research Inc

Markham, Ontario, L3P 1X3, Canada

Location

DermEdge Research Incorporated

Mississauga, Ontario, L4Y 4C5, Canada

Location

Allergy Research Canada Incorporated

Niagara Falls, Ontario, L2H 1H5, Canada

Location

North Bay Dermatology Centre

North Bay, Ontario, P1B 3Z7, Canada

Location

Dermatology Ottawa Research Centre

Ottawa, Ontario, K2C 3N2, Canada

Location

FACET Dermatology

Toronto, Ontario, M4E 1R7, Canada

Location

Alliance Clinical Trials

Waterloo, Ontario, N2J 1C4, Canada

Location

XLR8 Medical Research, Incorporated

Windsor, Ontario, N8T 1E6, Canada

Location

Skinsense Medical Research

Saskatoon, Saskatchewan, S7K 2C1, Canada

Location

Ekihigashi Dermatology Allergy Clinic

Fukuoka, Fukuoka, 812-0013, Japan

Location

Fukuoka University Hospital

Fukuoka, Fukuoka, 814-0180, Japan

Location

Matsuo Clinic

Fukuoka, Fukuoka, 819-0373, Japan

Location

Suizenji Dermatology Clinic

Kumamoto, Kumamoto, 862-0950, Japan

Location

Dermatology and Ophthalmology Kume Clinic

Sakai-shi, Osaka, 593-8324, Japan

Location

Mita Dermatology Clinic

Minato-ku, Tokyo, 108-0014, Japan

Location

Keio University Hospital

Shinjuku-ku, Tokyo, 160-8582, Japan

Location

Korea University Ansan Hospital

Ansan-si, Gyeonggi-do, 15355, South Korea

Location

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

Location

Kyung Hee University Hospital at Gangdong

Seoul, 05278, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

The Catholic University of Korea Seoul St Marys Hospital

Seoul, 06591, South Korea

Location

Hallym University Kangnam Sacred Heart Hospital

Seoul, 07441, South Korea

Location

Ajou University Hospital

Suwon-si, Gyeonggi-do, 16499, South Korea

Location

Related Publications (1)

• Guttman-Yassky E, Simpson E, Bissonnette R, Eichenfield LF, Kabashima K, Luna PC, Hercogova JT, Spelman L, Worm M, Esfandiari E, Arai T, Mano H, Charuworn P, Wang A, Kricorian G. ROCKET: a phase 3 program evaluating the efficacy and safety of rocatinlimab in moderate-to-severe atopic dermatitis. Immunotherapy. 2025 Feb;17(2):83-94. doi: 10.1080/1750743X.2025.2464528. Epub 2025 Feb 26.

  PMID: 40012373 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: January 25, 2024
• Study Start: April 2, 2024
• Primary Completion: April 11, 2025
• Study Completion: March 16, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

KR (7); US (22); CA (11); JP (7)