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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05633355
Registration number
NCT05633355
Ethics application status
Date submitted
22/11/2022
Date registered
1/12/2022
Date last updated
21/05/2024
Titles & IDs
Public title
A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
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Scientific 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)
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Secondary ID [1]
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2022-001548-99
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Secondary ID [2]
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20210263
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Universal Trial Number (UTN)
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Trial acronym
ROCKET-Orbit
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Rocatinlimab
Experimental: Rocatinlimab - Rocatinlimab will be administered subcutaneously every 4 weeks (Q4W) for 52 weeks with one additional dose at Week 2.
Treatment: Drugs: Rocatinlimab
Subcutaneous (SC) injection
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Treatment-emergent Serious Adverse Events
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Assessment method [1]
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Timepoint [1]
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Up to 52 Weeks
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Eligibility
Key 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
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Minimum age
12
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Maximum age
17
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/01/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
28/07/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
187
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
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Recruitment hospital [1]
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Woden Dermatology - Phillip
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Recruitment hospital [2]
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The Skin Hospital - Darlinghurst
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Recruitment hospital [3]
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Premier Specialists - Kogarah
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Liverpool Hospital - Liverpool
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Royal North Shore Hospital - St Leonards
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Recruitment hospital [6]
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The Skin Centre - Benowa
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Recruitment hospital [7]
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Veracity Clinical Research - Woolloongabba
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Recruitment hospital [8]
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Monash Childrens Hospital - Clayton
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Recruitment hospital [9]
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Institute for Skin Health and Immunity - Mitcham
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Recruitment postcode(s) [1]
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2606 - Phillip
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Recruitment postcode(s) [2]
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2010 - Darlinghurst
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Recruitment postcode(s) [3]
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2217 - Kogarah
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2170 - Liverpool
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2065 - St Leonards
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Recruitment postcode(s) [6]
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4217 - Benowa
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Recruitment postcode(s) [7]
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4102 - Woolloongabba
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Recruitment postcode(s) [8]
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3168 - Clayton
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Recruitment postcode(s) [9]
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3132 - Mitcham
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Recruitment outside Australia
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United States of America
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Arizona
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Redruth
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Amgen
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objective of this study is to describe the safety and tolerability of
rocatinlimab in adolescents with moderate-to-severe AD.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05633355
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Contacts
Principal investigator
Name
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MD
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Address
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Amgen
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05633355
Download to PDF