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A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-SHUTTLE)

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ClinicalTrials.gov Identifier: NCT05724199
Recruitment Status : Active, not recruiting
First Posted : February 13, 2023
Last Update Posted : April 24, 2024
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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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).

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Rocatinlimab Other: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 746 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : February 21, 2023
Estimated Primary Completion Date : September 16, 2024
Estimated Study Completion Date : January 6, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arms and Interventions
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Arm Intervention/treatment
Experimental: Rocatinlimab Dose 1 + TCS/TCI
Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks + TCS/TCI + loading dose at Week 2.
 Drug: Rocatinlimab
Subcutaneous (SC) injection
Other Name: AMG 451
Experimental: Rocatinlimab Dose 2 + TCS/TCI
Rocatinlimab Dose 2 Q4W for 24 weeks + TCS/TCI + loading dose at Week 2.
 Drug: Rocatinlimab
Subcutaneous (SC) injection
Other Name: AMG 451
Placebo Comparator: Placebo + TCS/TCI
Placebo Q4W for 24 weeks + TCS/TCI + loading dose at Week 2.
 Other: Placebo
SC injection


Outcome Measures
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Primary Outcome Measures :
  1. Achievement of a vIGA-AD Score of 0 or 1 with a ≥2 Point Reduction From Baseline at Week 24 [ Time Frame: Baseline, Week 24 ]
  2. Achievement of ≥ 75% Reduction From Baseline in EASI Score (EASI 75) at Week 24 [ Time Frame: Baseline, Week 24 ]

Secondary Outcome Measures :
  1. Achievement of EASI 75 at Week 16 [ Time Frame: Baseline, Week 16 ]
  2. Achievement of vIGA-AD 0/1 at Week 16 [ Time Frame: Baseline, Week 16 ]
  3. 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 [ Time Frame: Baseline, Week 16 ]
  4. 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 [ Time Frame: Baseline, Week 24 ]
  5. Achievement of ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24 [ Time Frame: Baseline, Week 24 ]
  6. 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 [ Time Frame: Baseline, Week 24 ]
  7. 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 [ Time Frame: Baseline, Week 24 ]
  8. Achievement of a Facial AD Severity Score of Clear at Week 24 for Participants with Facial AD at Baseline [ Time Frame: Baseline, Week 24 ]
  9. Achievement of a Hand AD Severity Score of Clear at Week 24 for Participants with Hand AD at Baseline [ Time Frame: Baseline, Week 24 ]
  10. Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16 [ Time Frame: Baseline, Week 16 ]
  11. Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 [ Time Frame: Baseline, Week 24 ]
  12. Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16 [ Time Frame: Baseline, Week 16 ]
  13. Change From Baseline in SCORAD Itch VAS Score at Week 24 [ Time Frame: Baseline, Week 24 ]
  14. Achievement of ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants With Baseline DLQI Score ≥ 4 [ Time Frame: Baseline, Week 24 ]
  15. Change from Baseline in DLQI Score at Week 24 [ Time Frame: Baseline, Week 24 ]
  16. 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 [ Time Frame: Baseline, Week 24 ]
  17. Change From Baseline in POEM Score at Week 24 [ Time Frame: Baseline, Week 24 ]
  18. 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 [ Time Frame: Baseline, Week 16 ]
  19. Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24 [ Time Frame: Baseline, Week 24 ]
  20. Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 [ Time Frame: Baseline, Week 16 ]
  21. 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 [ Time Frame: Baseline, Week 24 ]
  22. 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 [ Time Frame: Baseline, Week 16 ]
  23. Change From Baseline in Weekly Average of Sleep Disturbance NRS Score at Week 24 [ Time Frame: Baseline, Week 24 ]
  24. 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 [ Time Frame: Baseline, Week 24 ]
  25. Achievement of a HADS-depression Subscale Score < 8 at Week 24 in Participants with Baseline HADS-depression Subscale Score ≥ 8 [ Time Frame: Baseline, Week 24 ]
  26. Change From Baseline in HADS-anxiety Subscale Score at Week 24 [ Time Frame: Baseline, Week 24 ]
  27. Change From Baseline in HADS-depression Subscale Score at Week 24 [ Time Frame: Baseline, Week 24 ]
  28. Achievement of a ≥ 8.7-point Reduction from Baseline in SCORAD Score at Week 24 in Participants with Baseline SCORAD Score ≥ 8.7 [ Time Frame: Baseline, Week 24 ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05724199


Locations
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Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT05724199    
Other Study ID Numbers: 20210144
2022-501585-22 ( Registry Identifier: CTIS (EU) )
First Posted: February 13, 2023    Key Record Dates
Last Update Posted: April 24, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
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.
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.
URL: http://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
Atopic Dermatitis
AMG 451
Eczema
Rocatinlimab
KHK4083
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases