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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05724199




Registration number
NCT05724199
Ethics application status
Date submitted
2/02/2023
Date registered
13/02/2023

Titles & IDs
Public title
A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)
Scientific title
A Phase 3, Randomized, 24-week, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Combination With Topical Corticosteroids and/or Topical Calcineurin Inhibitors in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-SHUTTLE)
Secondary ID [1] 0 0
2022-501585-22
Secondary ID [2] 0 0
20210144
Universal Trial Number (UTN)
Trial acronym
ROCKET-SHUTTLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rocatinlimab
Other interventions - Placebo

Experimental: Rocatinlimab Dose 1 + TCS/TCI - Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks + TCS/TCI + loading dose at Week 2.

Experimental: Rocatinlimab Dose 2 + TCS/TCI - Rocatinlimab Dose 2 Q4W for 24 weeks + TCS/TCI + loading dose at Week 2.

Placebo comparator: Placebo + TCS/TCI - Placebo Q4W for 24 weeks + TCS/TCI + loading dose at Week 2.


Treatment: Drugs: Rocatinlimab
Subcutaneous (SC) injection

Other interventions: Placebo
SC injection
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Achievement of a vIGA-AD Score of 0 or 1 with a =2 Point Reduction From Baseline at Week 24
Timepoint [1] 0 0
Baseline, Week 24
Primary outcome [2] 0 0
Achievement of = 75% Reduction From Baseline in EASI Score (EASI 75) at Week 24
Timepoint [2] 0 0
Baseline, Week 24
Secondary outcome [1] 0 0
Achievement of EASI 75 at Week 16
Timepoint [1] 0 0
Baseline, Week 16
Secondary outcome [2] 0 0
Achievement of vIGA-AD 0/1 at Week 16
Timepoint [2] 0 0
Baseline, Week 16
Secondary outcome [3] 0 0
Achievement of a = 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus Numeric Rating Scale (NRS) Score at Week 16 in Participants with Baseline Weekly Average of Daily Worst Pruritus NRS Score = 4
Timepoint [3] 0 0
Baseline, Week 16
Secondary outcome [4] 0 0
Achievement of a = 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 in Participants with Baseline Weekly Average of Daily Worst Pruritus NRS Score = 4
Timepoint [4] 0 0
Baseline, Week 24
Secondary outcome [5] 0 0
Achievement of = 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24
Timepoint [5] 0 0
Baseline, Week 24
Secondary outcome [6] 0 0
Achievement of a = 4-point Reduction From Baseline in Weekly Average of AD Skin Pain NRS Score at Week 24 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score = 4
Timepoint [6] 0 0
Baseline, Week 24
Secondary outcome [7] 0 0
Achievement of vIGA-AD 1 Response with a Presence of Only Barely Perceptible Erythema or vlGA-AD 0 Response (Revised IGA [rIGA™] 0/1) at Week 24
Timepoint [7] 0 0
Baseline, Week 24
Secondary outcome [8] 0 0
Achievement of a Facial AD Severity Score of Clear at Week 24 for Participants with Facial AD at Baseline
Timepoint [8] 0 0
Baseline, Week 24
Secondary outcome [9] 0 0
Achievement of a Hand AD Severity Score of Clear at Week 24 for Participants with Hand AD at Baseline
Timepoint [9] 0 0
Baseline, Week 24
Secondary outcome [10] 0 0
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16
Timepoint [10] 0 0
Baseline, Week 16
Secondary outcome [11] 0 0
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24
Timepoint [11] 0 0
Baseline, Week 24
Secondary outcome [12] 0 0
Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16
Timepoint [12] 0 0
Baseline, Week 16
Secondary outcome [13] 0 0
Change From Baseline in SCORAD Itch VAS Score at Week 24
Timepoint [13] 0 0
Baseline, Week 24
Secondary outcome [14] 0 0
Achievement of = 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants With Baseline DLQI Score = 4
Timepoint [14] 0 0
Baseline, Week 24
Secondary outcome [15] 0 0
Change from Baseline in DLQI Score at Week 24
Timepoint [15] 0 0
Baseline, Week 24
Secondary outcome [16] 0 0
Achievement of a = 4-point Reduction From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 24 in Participants with Baseline POEM Score = 4
Timepoint [16] 0 0
Baseline, Week 24
Secondary outcome [17] 0 0
Change From Baseline in POEM Score at Week 24
Timepoint [17] 0 0
Baseline, Week 24
Secondary outcome [18] 0 0
Achievement of a = 4-point Reduction From Baseline in Weekly Average of AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of AD skin pain NRS Score = 4
Timepoint [18] 0 0
Baseline, Week 16
Secondary outcome [19] 0 0
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24
Timepoint [19] 0 0
Baseline, Week 24
Secondary outcome [20] 0 0
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16
Timepoint [20] 0 0
Baseline, Week 16
Secondary outcome [21] 0 0
Achievement of a = 3-point Reduction From Baseline in Weekly Average of AD Skin Pain NRS Score at Week 24 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score = 3
Timepoint [21] 0 0
Baseline, Week 24
Secondary outcome [22] 0 0
Achievement of a = 3-point Reduction From Baseline in Weekly Average of AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score = 3
Timepoint [22] 0 0
Baseline, Week 16
Secondary outcome [23] 0 0
Change From Baseline in Weekly Average of Sleep Disturbance NRS Score at Week 24
Timepoint [23] 0 0
Baseline, Week 24
Secondary outcome [24] 0 0
Achievement of a Hospital Anxiety and Depression Scale (HADS)-anxiety Subscale Score < 8 at Week 24 in Participants with Baseline HADS-anxiety Subscale Score = 8
Timepoint [24] 0 0
Baseline, Week 24
Secondary outcome [25] 0 0
Achievement of a HADS-depression Subscale Score < 8 at Week 24 in Participants with Baseline HADS-depression Subscale Score = 8
Timepoint [25] 0 0
Baseline, Week 24
Secondary outcome [26] 0 0
Change From Baseline in HADS-anxiety Subscale Score at Week 24
Timepoint [26] 0 0
Baseline, Week 24
Secondary outcome [27] 0 0
Change From Baseline in HADS-depression Subscale Score at Week 24
Timepoint [27] 0 0
Baseline, Week 24
Secondary outcome [28] 0 0
Achievement of a = 8.7-point Reduction from Baseline in SCORAD Score at Week 24 in Participants with Baseline SCORAD Score = 8.7
Timepoint [28] 0 0
Baseline, Week 24

Eligibility
Key inclusion criteria
* Age = 18 years with a diagnosis of AD according to the AAD (American Academy of Dermatology) Consensus Criteria (2014) present for at least 12 months
* History of inadequate response to TCS of medium or higher potency (with or without TCI)
* EASI score =16
* vIGA-AD score =3
* =10% body surface area (BSA) of AD involvement
* Worst pruritus numerical rating scale = 4
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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
* Nonbiologic, non-targeted Systemic immunosuppressants
* Phototherapy
* Janus kinase inhibitors
* Treatment with any of the following medications or therapies within 1 week, prior to Day 1:

* TCS
* TCI
* Topical phosphodiesterase type 4 inhibitors
* Other topical immunosuppressive agents
* Combination topical agents including TCS of any potency or TCI, PDE4 inhibitors, or other topical immunosuppressive agents

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/12/2024
Sample size
Target
Accrual to date
Final
746
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Emeritus Research Sydney - Botany
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
The Skin Centre - Benowa
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - South Brisbane
Recruitment hospital [5] 0 0
Veracity Clinical Research - Woolloongabba
Recruitment hospital [6] 0 0
Emeritus Research Melbourne - Camberwell
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4217 - Benowa
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
3124 - Camberwell
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.amgen.com/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05724199