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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05651711




Registration number
NCT05651711
Ethics application status
Date submitted
7/12/2022
Date registered
15/12/2022

Titles & IDs
Public title
A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)
Scientific title
A Phase 3, Randomized, 24-week, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety and Tolerability of Rocatinlimab (AMG 451) Monotherapy in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)
Secondary ID [1] 0 0
2022-501538-44
Secondary ID [2] 0 0
20210143
Universal Trial Number (UTN)
Trial acronym
ROCKET-Horizon
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 - Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.

Placebo comparator: Placebo - Placebo Q4W for 24 weeks with a loading dose at Week 2.


Treatment: Drugs: Rocatinlimab
Rocatinlimab will be administered through a subcutaneous (SC) injection.

Other interventions: Placebo
The matching placebo will be administered through a 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 Validated Investigator's Global Assessment for Atopic Dermatitis Score of 0 (Clear) or 1 (Almost Clear) with a = 2 Point Reduction From Baseline (vIGA-AD 0/1) at Week 24
Timepoint [1] 0 0
Baseline and 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 and Week 24
Secondary outcome [1] 0 0
Achievement of EASI 75 at Week 16
Timepoint [1] 0 0
Baseline and Week 16
Secondary outcome [2] 0 0
Achievement of vIGA-AD 0/1 at Week 16
Timepoint [2] 0 0
Baseline and 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 and 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 and 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 and Week 24
Secondary outcome [6] 0 0
Achievement of = 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 to Week 24
Secondary outcome [7] 0 0
Achievement of vIGA-AD 1 Response With Presence of Only Barely Perceptible Erythema or vIGA-AD 0 Response (Revised Investigator's Global Assessment [rIGA] 0/1) at Week 24
Timepoint [7] 0 0
Baseline and 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 and 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 and 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 and 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 and 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 and Week 16
Secondary outcome [13] 0 0
Change From Baseline in SCORAD Itch VAS Score at Week 24
Timepoint [13] 0 0
Baseline and Week 24
Secondary outcome [14] 0 0
Achievement of a = 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants with Baseline DLQI = 4
Timepoint [14] 0 0
Baseline and Week 24
Secondary outcome [15] 0 0
Change From Baseline in DLQI Score at Week 24
Timepoint [15] 0 0
Baseline and 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 and Week 24
Secondary outcome [17] 0 0
Change from Baseline in POEM Score at Week 24
Timepoint [17] 0 0
Baseline and Week 24
Secondary outcome [18] 0 0
Achievement of = 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 to 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 to 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 and Week 16
Secondary outcome [21] 0 0
Achievement of = 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 to Week 24
Secondary outcome [22] 0 0
Achievement of = 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 to Week 16
Secondary outcome [23] 0 0
Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24
Timepoint [23] 0 0
Baseline to Week 24
Secondary outcome [24] 0 0
Achievement of 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 and Week 24
Secondary outcome [25] 0 0
Achievement of HADS-depression Subscale Score <8 at Week 24 in Participants with Baseline HADS-depression Subscale Score = 8
Timepoint [25] 0 0
Baseline and Week 24
Secondary outcome [26] 0 0
Change From Baseline in HADS-anxiety Subscale Score at Week 24
Timepoint [26] 0 0
Baseline and Week 24
Secondary outcome [27] 0 0
Change From Baseline in HADS-depression Subscale Score at Week 24
Timepoint [27] 0 0
Baseline and 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 and Week 24

Eligibility
Key inclusion criteria
* Age = 18 years (or = legal adult age within the country if it is older than 18 years at signing of informed consent) with a diagnosis of AD according to the AAD Consensus Criteria (2014) present for at least 12 months
* History of inadequate response to TCS (Topical Corticosteroid) of medium or 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).
* 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
* Systemic immunosuppressants
* Phototherapy
* Oral or topical Janus kinase inhibitors
* Treatment with any of the following medications or therapies within 1 week, prior to Day 1:

* TCS of any potency
* TCI
* Topical phosphodiesterase type 4 (PDE4) inhibitors
* Other topical immunosuppressive agents
* Combination agents including TCS of any potency or TCI, PDE4 inhibitors, or other 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
Parallel
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
14/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/08/2024
Sample size
Target
Accrual to date
Final
726
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
St George Dermatology and Skin Cancer Centre - Darlinghurst
Recruitment hospital [2] 0 0
Premier Specialists - Kogarah
Recruitment hospital [3] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [4] 0 0
Skin Health Institute - Carlton
Recruitment hospital [5] 0 0
Sinclair Dermatology - East Melbourne
Recruitment hospital [6] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [7] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
3053 - Carlton
Recruitment postcode(s) [5] 0 0
3002 - East Melbourne
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arkansas
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California
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United States of America
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Colorado
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District of Columbia
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Florida
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Georgia
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Illinois
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Indiana
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Kansas
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Kentucky
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Massachusetts
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Michigan
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Nebraska
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Nevada
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New Hampshire
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New Jersey
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North Carolina
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Ohio
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Oregon
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Rhode Island
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Bruxelles
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Herstal
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Maldegem
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Porto
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Romania
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Bucharest
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South Africa
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Gauteng
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South Africa
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Durban
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Spain
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Andalucía
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Spain
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Comunidad Valenciana
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Navarra
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Madrid
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Majadahonda
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Sweden
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Stockholm
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Ankara
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Southampton

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/NCT05651711