search
Back to results

A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Orbit)

Primary Purpose

Atopic Dermatitis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rocatinlimab
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic Dermatitis, Rocatinlimab, AMG 451, KHK4083

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 12 to < 18 years at day 1. Participant has a diagnosis of AD (according to American Academy of Dermatology Consensus Criteria [Eichenfield, 2014]) that has been present for at least 12 months before signing of informed consent Prior to informed consent, history of inadequate response to topical corticosteroids (TCS) of medium to higher potency (with or without topical calcineurin inhibitors [TCI] as appropriate) or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks) Eczema Area and Severity Index (EASI) score ≥ 12 vIGA-AD score ≥ 3 ≥ 10% BSA of AD involvement at day 1 pre-enrollment Exclusion Criteria: Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1 Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1: Systemic corticosteroids Systemic immunosuppressants Phototherapy Oral or topical janus kinase inhibitors Treatment with any of the following agents within 1 week before day 1 pre-enrollment: Topical PDE4 inhibitors Other topical immunosuppressive agents (not including TCS/TCI) Combination topical agents containing a high- or super-high potency corticosteroid

Sites / Locations

  • Phoenix Childrens HosptialRecruiting
  • Medical Advancement Centers of ArizonaRecruiting
  • Dermatology Trial AssociatesRecruiting
  • Little Rock Allergy and Asthma Clinical Research CenterRecruiting
  • Dermatology Research AssociatesRecruiting
  • Manlio DermatologyRecruiting
  • Bluegrass Allergy CareRecruiting
  • Windsor Dermatology dba Eczema Treatment Center of New JerseyRecruiting
  • Icahn School of Medicine at Mount SinaiRecruiting
  • Oregon Medical Research CenterRecruiting
  • DermDox Dermatology, LLC
  • Driscoll Childrens HospitalRecruiting
  • Modern Research AssociatesRecruiting
  • Center for Clinical StudiesRecruiting
  • University of Utah MidValley DermatologyRecruiting
  • Cinme - Centro de Investigaciones MetabolicasRecruiting
  • Fundacion CIDEARecruiting
  • Instituto de Neumonologia y DermatologiaRecruiting
  • Centro de Investigaciones Clínicas del Instituto Especialidades de la Salud RosarioRecruiting
  • Fundacion Estudios ClinicosRecruiting
  • Instituto de Diagnostico ABCRecruiting
  • Woden DermatologyRecruiting
  • Premier SpecialistsRecruiting
  • Liverpool HospitalRecruiting
  • Royal North Shore HospitalRecruiting
  • The Skin CentreRecruiting
  • Veracity Clinical ResearchRecruiting
  • Monash Medical CentreRecruiting
  • Hospital Ernesto DornellesRecruiting
  • Fundacao do ABC - Centro Universitario FMABCRecruiting
  • Sociedade Beneficente de Senhoras Hospital Sirio LibanesRecruiting
  • ISPEM - Instituto São José dos Campos em Pesquisas MédicasRecruiting
  • Alergoalfa Nucleo Diagnostico Tratamento e Pesquisa Clinica em AlergiaRecruiting
  • Dermatology Research Institute IncorporatedRecruiting
  • Vida Clinical ResearchRecruiting
  • Winnipeg Clinic Dermatology ResearchRecruiting
  • Skincare StudioRecruiting
  • SimcoDerm Medical and Surgical Dermatology CentreRecruiting
  • Halton Pediatric AllergyRecruiting
  • LEADER ResearchRecruiting
  • JRB Research IncorporatedRecruiting
  • SKiN Centre for DermatologyRecruiting
  • Toronto Research Centre IncRecruiting
  • Queen Mary HospitalRecruiting
  • Korea University Ansan HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • National Medical CenterRecruiting
  • Kyung Hee University Hospital at GangdongRecruiting
  • The Catholic Univ of Korea Seoul St Marys HospitalRecruiting
  • Chung-Ang University HospitalRecruiting
  • Hallym University Kangnam Sacred Heart HospitalRecruiting
  • Ewha Womans University Seoul HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rocatinlimab

Arm Description

Rocatinlimab will be administered subcutaneously every 4 weeks (Q4W) for 52 weeks with one additional dose at Week 2.

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-emergent Serious Adverse Events

Secondary Outcome Measures

Full Information

First Posted
November 22, 2022
Last Updated
October 12, 2023
Sponsor
Amgen
search

1. Study Identification

Unique Protocol Identification Number
NCT05633355
Brief Title
A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
Acronym
ROCKET-Orbit
Official Title
A Phase 3, Open-label, 52-week Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab (AMG 451) in Adolescent Subjects Aged ≥ 12 to < 18 Years With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Orbit)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
July 21, 2025 (Anticipated)
Study Completion Date
July 21, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic Dermatitis, Rocatinlimab, AMG 451, KHK4083

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rocatinlimab
Arm Type
Experimental
Arm Description
Rocatinlimab will be administered subcutaneously every 4 weeks (Q4W) for 52 weeks with one additional dose at Week 2.
Intervention Type
Drug
Intervention Name(s)
Rocatinlimab
Other Intervention Name(s)
AMG 451
Intervention Description
Subcutaneous (SC) injection
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-emergent Serious Adverse Events
Time Frame
Up to 52 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 12 to < 18 years at day 1. Participant has a diagnosis of AD (according to American Academy of Dermatology Consensus Criteria [Eichenfield, 2014]) that has been present for at least 12 months before signing of informed consent Prior to informed consent, history of inadequate response to topical corticosteroids (TCS) of medium to higher potency (with or without topical calcineurin inhibitors [TCI] as appropriate) or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks) Eczema Area and Severity Index (EASI) score ≥ 12 vIGA-AD score ≥ 3 ≥ 10% BSA of AD involvement at day 1 pre-enrollment Exclusion Criteria: Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1 Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1: Systemic corticosteroids Systemic immunosuppressants Phototherapy Oral or topical janus kinase inhibitors Treatment with any of the following agents within 1 week before day 1 pre-enrollment: Topical PDE4 inhibitors Other topical immunosuppressive agents (not including TCS/TCI) Combination topical agents containing a high- or super-high potency corticosteroid
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amgen Call Center
Phone
866-572-6436
Email
medinfo@amgen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Phoenix Childrens Hosptial
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Advancement Centers of Arizona
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Individual Site Status
Recruiting
Facility Name
Dermatology Trial Associates
City
Bryant
State/Province
Arkansas
ZIP/Postal Code
72022
Country
United States
Individual Site Status
Recruiting
Facility Name
Little Rock Allergy and Asthma Clinical Research Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Individual Site Status
Recruiting
Facility Name
Manlio Dermatology
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Individual Site Status
Recruiting
Facility Name
Bluegrass Allergy Care
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Individual Site Status
Recruiting
Facility Name
Windsor Dermatology dba Eczema Treatment Center of New Jersey
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Individual Site Status
Recruiting
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Medical Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Individual Site Status
Recruiting
Facility Name
DermDox Dermatology, LLC
City
Sugarloaf
State/Province
Pennsylvania
ZIP/Postal Code
18249
Country
United States
Individual Site Status
Terminated
Facility Name
Driscoll Childrens Hospital
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78411
Country
United States
Individual Site Status
Recruiting
Facility Name
Modern Research Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Name
Center for Clinical Studies
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Utah MidValley Dermatology
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Name
Cinme - Centro de Investigaciones Metabolicas
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1027AAP
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Fundacion CIDEA
City
Ciudad Autonoma de Buenos Aires
State/Province
Distrito Federal
ZIP/Postal Code
1121
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Instituto de Neumonologia y Dermatologia
City
Ciudad Autonoma de Buenos Aires
State/Province
Distrito Federal
ZIP/Postal Code
1425
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro de Investigaciones Clínicas del Instituto Especialidades de la Salud Rosario
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Fundacion Estudios Clinicos
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Instituto de Diagnostico ABC
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Woden Dermatology
City
Phillip
State/Province
Australian Capital Territory
ZIP/Postal Code
2606
Country
Australia
Individual Site Status
Recruiting
Facility Name
Premier Specialists
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Individual Site Status
Recruiting
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal North Shore Hospital
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Skin Centre
City
Benowa
State/Province
Queensland
ZIP/Postal Code
4217
Country
Australia
Individual Site Status
Recruiting
Facility Name
Veracity Clinical Research
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Recruiting
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Name
Hospital Ernesto Dornelles
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90160-093
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Fundacao do ABC - Centro Universitario FMABC
City
Santo Andre
State/Province
São Paulo
ZIP/Postal Code
09060-870
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
01308-050
Country
Brazil
Individual Site Status
Recruiting
Facility Name
ISPEM - Instituto São José dos Campos em Pesquisas Médicas
City
São José dos Campos
State/Province
São Paulo
ZIP/Postal Code
12243-280
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Alergoalfa Nucleo Diagnostico Tratamento e Pesquisa Clinica em Alergia
City
São Paulo
ZIP/Postal Code
06454-010
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Dermatology Research Institute Incorporated
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2J 7E1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Vida Clinical Research
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6H 4J8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Winnipeg Clinic Dermatology Research
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 0N2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Skincare Studio
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1E 1V4
Country
Canada
Individual Site Status
Recruiting
Facility Name
SimcoDerm Medical and Surgical Dermatology Centre
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Halton Pediatric Allergy
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7L 6W6
Country
Canada
Individual Site Status
Recruiting
Facility Name
LEADER Research
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 3C3
Country
Canada
Individual Site Status
Recruiting
Facility Name
JRB Research Incorporated
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2C 3N2
Country
Canada
Individual Site Status
Recruiting
Facility Name
SKiN Centre for Dermatology
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Toronto Research Centre Inc
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3H 5Y8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Korea University Ansan Hospital
City
Ansansi, Gyeonggido
ZIP/Postal Code
15355
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
National Medical Center
City
Seoul
ZIP/Postal Code
04564
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kyung Hee University Hospital at Gangdong
City
Seoul
ZIP/Postal Code
05278
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic Univ of Korea Seoul St Marys Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Chung-Ang University Hospital
City
Seoul
ZIP/Postal Code
06973
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Hallym University Kangnam Sacred Heart Hospital
City
Seoul
ZIP/Postal Code
07441
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Ewha Womans University Seoul Hospital
City
Seoul
ZIP/Postal Code
07804
Country
Korea, Republic of
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://www.amgen.com/datasharing
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

We'll reach out to this number within 24 hrs