A Study With Self-administered Rocatinlimab in Adolescent and Adult Participants With Moderate-to-severe AD (ROCKET-Outpost)

April 17, 2024 updated by: Amgen

A Phase 3, Multicenter, Randomized, Open-label, Performance Study With Self-administered Subcutaneous Rocatinlimab (AMG 451) in Adolescent and Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Outpost)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Long Beach, California, United States, 90805
        • Recruiting
        • Long Beach Research Institute
      • Los Angeles, California, United States, 90045
        • Recruiting
        • Dermatology Research Associates
      • Sacramento, California, United States, 95815
        • Recruiting
        • Integrative Skin Science and Research
    • Florida
      • Miami, Florida, United States, 33176
        • Recruiting
        • Anchor Medical Research
    • Georgia
      • Alpharetta, Georgia, United States, 30022
        • Recruiting
        • Hamilton Research, LLC
    • Idaho
      • Boise, Idaho, United States, 83706
        • Recruiting
        • Treasure Valley Medical Research
    • Kansas
      • Leawood, Kansas, United States, 66211
        • Recruiting
        • Dermatology and Skin Cancer Center Leawood
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Recruiting
        • Excel Clinical Research
      • North Las Vegas, Nevada, United States, 89030
        • Recruiting
        • Las Vegas Clinical Trials
      • Reno, Nevada, United States, 89509
        • Recruiting
        • Skin Cancer and Dermatology Institute
    • Ohio
      • Mayfield Heights, Ohio, United States, 44124
        • Recruiting
        • Apex Clinical Research Center LLC
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74137
        • Recruiting
        • Essential Medical Research LLC
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Recruiting
        • Health Concepts
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • Virginia Dermatology and Skin Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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:

    1. Systemic corticosteroids
    2. Non-biologic, non-targeted systemic immunosuppressants
    3. Oral or Topical Janus kinase inhibitors

  • Treatment with any of the following medications or therapies within 1 week before day 1 pre-randomization:

    1. Topical phosphodiesterase 4 (PDE4) inhibitors
    2. Other topical immunosuppressive agents (not including TCS/TCI)
    3. Combination topical agents containing any of the above components

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rocatinlimab Dose 1
Rocatinlimab will be self-administered subcutaneously using a prefilled syringe (PFS). Participants will receive rocatinlimab every 4 weeks (Q4W) for 52 weeks with a loading dose at week 2.
Combination product: Rocatinlimab Prefilled Syringe
Prefilled Syringe (PFS) for subcutaneous (SC) injection self-administration of rocatinlimab.
Other Names:
  • AMG 451
Experimental: Rocatinlimab Dose 2
Rocatinlimab will be self-administered subcutaneously using a PFS. Participants will receive rocatinlimab Q4W for 52 weeks with a loading dose at week 2.
Combination product: Rocatinlimab Prefilled Syringe
Prefilled Syringe (PFS) for subcutaneous (SC) injection self-administration of rocatinlimab.
Other Names:
  • AMG 451

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of full-dose self-administered rocatinlimab injections as reported by participants or caregivers among attempted home-use injections at weeks 4 and 12 combined
Time Frame: Up to Week 12
Up to Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of devices that have been reported with Product Complaints by participants, caregivers, or investigators among dispensed home-use devices at weeks 4 and 12 combined
Time Frame: Up to Week 12
Up to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Investigators

  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2024

Primary Completion (Estimated)

May 22, 2025

Study Completion (Estimated)

April 22, 2026

Study Registration Dates

First Submitted

January 17, 2024

First Submitted That Met QC Criteria

January 17, 2024

First Posted (Actual)

January 25, 2024

Study Record Updates

Last Update Posted (Estimated)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20230180

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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