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A Study Assessing Rocatinlimab on Vaccine Antibody Response in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-VOYAGER)

Primary Purpose

Atopic Dermatitis, Moderate-to-severe Atopic Dermatitis

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

About this trial

This is an interventional basic science trial for Atopic Dermatitis focused on measuring Moderate-to-severe Atopic Dermatitis, AD, Rocatinlimab

Eligibility Criteria

18 Years - 54 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 18 years to 54 years with a diagnosis of AD according to the American Academy of Dermatology (AAD) Consensus Criteria (2014) present for at least 12 months History of inadequate response to topical corticosteroids (TCS) of medium or higher potency (with or without topical calcineurin inhibitors) Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score ≥ 3 Exclusion Criteria: Treatment with a biologic 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 Janus kinase inhibitors Treatment with any of the following medications or therapies within 1 week, prior to Day 1: TCS Topical calcineurin inhibitors (TCI) Anti-pruritic agents or antihistamines used for treatment of pruritis Topical Phosphodiesterase-4 inhibitors (PDE4) Other topical immunosuppressive agents Combination topical agents containing a corticosteroid or calcineurin inhibiting component, PDE4 inhibitors, or other topical immunosuppressive agents Treatment with live virus including live attenuated vaccination 12 weeks prior to day 1 pre-randomization. Inactivated vaccination (eg, non-live or nonreplicating agent), including coronavirus disease 2019 (COVID-19) vaccination, is allowed. Treatment with any meningococcal vaccine within 1 year prior to screening, or treatment with any tetanus-, diphtheria-, or pertussis containing vaccine within 5 years prior to screening

Sites / Locations

  • Affiliated DermatologyRecruiting
  • Little Rock Allergy and Asthma Clinical Research CenterRecruiting
  • Kern Research IncRecruiting
  • Hope Clinical Research LLCRecruiting
  • Chemidox Clinical Trials IncorporatedRecruiting
  • Long Beach Research Institute, LLCRecruiting
  • Wallace Medical Group, IncRecruiting
  • Peninsula Research AssociatesRecruiting
  • Integrative Skin Science and ResearchRecruiting
  • Wolverine Clinical TrialsRecruiting
  • Cura Clinical ResearchRecruiting
  • Life Clinical TrialsRecruiting
  • D and H Doral Research CentersRecruiting
  • Meridian International ResearchRecruiting
  • Gold Coast Health Research CenterRecruiting
  • Anchor Medical ResearchRecruiting
  • Dermatologic Surgery SpecialistsRecruiting
  • Visage Dermatology and Aesthetic CenterRecruiting
  • Excel Clinical ResearchRecruiting
  • Skin Cancer and Dermatology InstituteRecruiting
  • The Skin Surgery CenterRecruiting
  • Apex DermatologyRecruiting
  • Oregon Dermatology and Research CenterRecruiting
  • Cumberland Skin CenterRecruiting
  • Sms Clinical Research Limited Liability CompanyRecruiting
  • Tranquil Clinical ResearchRecruiting
  • York Dermatology CentreRecruiting
  • FACET DermatologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rocatinlimab

Placebo

Arm Description

During the 24-week treatment period, the participants will receive rocatinlimab once every 4 weeks (Q4W) for 24 weeks with a loading dose given at Week 2.

During the 24-week treatment period, the participants will receive placebo Q4W for 24 weeks with a loading dose given at Week 2.

Outcomes

Primary Outcome Measures

Number of Participants with a Positive Anti-tetanus Response
Number of Participants with a Positive Anti-meningococcal Response
Number of Participants with a Treatment-emergent Adverse Event
Number of Participants with a Serious Adverse Event
Number of Participants with Anti-rocatinlimab Antibody Formation

Secondary Outcome Measures

Full Information

First Posted
June 2, 2023
Last Updated
September 6, 2023
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT05899816
Brief Title
A Study Assessing Rocatinlimab on Vaccine Antibody Response in Moderate-to-severe Atopic Dermatitis (AD)
Acronym
ROCKET-VOYAGER
Official Title
A Phase 3, 24-week, Randomized, Placebo-controlled, Double-blind Study to Assess the Effect of Rocatinlimab on Vaccine Antibody Response in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2023 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
January 23, 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 objectives of this study are to: estimate vaccine response in rocatinlimab group vs placebo group, assessed using antibody anti-tetanus response at Week 24 estimate vaccine response in rocatinlimab group vs placebo group, assessed using antibody anti-meningococcal response at Week 24 characterize the safety and tolerability of rocatinlimab in the proposed population evaluate the immunogenicity of rocatinlimab

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Moderate-to-severe Atopic Dermatitis
Keywords
Moderate-to-severe Atopic Dermatitis, AD, Rocatinlimab

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
195 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rocatinlimab
Arm Type
Experimental
Arm Description
During the 24-week treatment period, the participants will receive rocatinlimab once every 4 weeks (Q4W) for 24 weeks with a loading dose given at Week 2.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
During the 24-week treatment period, the participants will receive placebo Q4W for 24 weeks with a loading dose given at Week 2.
Intervention Type
Drug
Intervention Name(s)
Rocatinlimab
Other Intervention Name(s)
AMG 451, KHK4083
Intervention Description
Subcutaneous (SC) injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
SC injection
Primary Outcome Measure Information:
Title
Number of Participants with a Positive Anti-tetanus Response
Time Frame
Week 20 to week 24
Title
Number of Participants with a Positive Anti-meningococcal Response
Time Frame
Week 20 to week 24
Title
Number of Participants with a Treatment-emergent Adverse Event
Time Frame
Up to 36 weeks
Title
Number of Participants with a Serious Adverse Event
Time Frame
Up to 36 weeks
Title
Number of Participants with Anti-rocatinlimab Antibody Formation
Time Frame
Up to 36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years to 54 years with a diagnosis of AD according to the American Academy of Dermatology (AAD) Consensus Criteria (2014) present for at least 12 months History of inadequate response to topical corticosteroids (TCS) of medium or higher potency (with or without topical calcineurin inhibitors) Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score ≥ 3 Exclusion Criteria: Treatment with a biologic 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 Janus kinase inhibitors Treatment with any of the following medications or therapies within 1 week, prior to Day 1: TCS Topical calcineurin inhibitors (TCI) Anti-pruritic agents or antihistamines used for treatment of pruritis Topical Phosphodiesterase-4 inhibitors (PDE4) Other topical immunosuppressive agents Combination topical agents containing a corticosteroid or calcineurin inhibiting component, PDE4 inhibitors, or other topical immunosuppressive agents Treatment with live virus including live attenuated vaccination 12 weeks prior to day 1 pre-randomization. Inactivated vaccination (eg, non-live or nonreplicating agent), including coronavirus disease 2019 (COVID-19) vaccination, is allowed. Treatment with any meningococcal vaccine within 1 year prior to screening, or treatment with any tetanus-, diphtheria-, or pertussis containing vaccine within 5 years prior to screening
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
Affiliated Dermatology
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85255
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
Kern Research Inc
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Individual Site Status
Recruiting
Facility Name
Hope Clinical Research LLC
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Individual Site Status
Recruiting
Facility Name
Chemidox Clinical Trials Incorporated
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Individual Site Status
Recruiting
Facility Name
Long Beach Research Institute, LLC
City
Long Beach
State/Province
California
ZIP/Postal Code
90805
Country
United States
Individual Site Status
Recruiting
Facility Name
Wallace Medical Group, Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90056
Country
United States
Individual Site Status
Recruiting
Facility Name
Peninsula Research Associates
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
Individual Site Status
Recruiting
Facility Name
Integrative Skin Science and Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Individual Site Status
Recruiting
Facility Name
Wolverine Clinical Trials
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Individual Site Status
Recruiting
Facility Name
Cura Clinical Research
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Individual Site Status
Recruiting
Facility Name
Life Clinical Trials
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33071
Country
United States
Individual Site Status
Recruiting
Facility Name
D and H Doral Research Centers
City
Doral
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian International Research
City
Miami Gardens
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Name
Gold Coast Health Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Name
Anchor Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Name
Dermatologic Surgery Specialists
City
Macon
State/Province
Georgia
ZIP/Postal Code
31217
Country
United States
Individual Site Status
Recruiting
Facility Name
Visage Dermatology and Aesthetic Center
City
Largo
State/Province
Maryland
ZIP/Postal Code
20774
Country
United States
Individual Site Status
Recruiting
Facility Name
Excel Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Individual Site Status
Recruiting
Facility Name
Skin Cancer and Dermatology Institute
City
Reno
State/Province
Nevada
ZIP/Postal Code
89509
Country
United States
Individual Site Status
Recruiting
Facility Name
The Skin Surgery Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Name
Apex Dermatology
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Dermatology and Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Individual Site Status
Recruiting
Facility Name
Cumberland Skin Center
City
Hermitage
State/Province
Tennessee
ZIP/Postal Code
37076
Country
United States
Individual Site Status
Recruiting
Facility Name
Sms Clinical Research Limited Liability Company
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Individual Site Status
Recruiting
Facility Name
Tranquil Clinical Research
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Individual Site Status
Recruiting
Facility Name
York Dermatology Centre
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4C 9M7
Country
Canada
Individual Site Status
Recruiting
Facility Name
FACET Dermatology
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4C 1L1
Country
Canada
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 Assessing Rocatinlimab on Vaccine Antibody Response in Moderate-to-severe Atopic Dermatitis (AD)

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