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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
Date last updated
27/09/2024

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
Active, not recruiting
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
9/12/2024
Actual
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
The coprimary objectives of the study are to:

* evaluate the efficacy of rocatinlimab in combination with topical corticosteroid and/or topical calcineurin inhibitor (TCS/TCI), compared with placebo in combination with TCS/TCI at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™).
* evaluate the efficacy of rocatinlimab, in combination with TCS/TCI, compared with placebo in combination with TCS/TCI at Week 24, assessed using Eczema Area and Severity Index (EASI).
Trial website
https://clinicaltrials.gov/study/NCT05724199
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05724199