A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon) (ROCKET-Horizon)

• ClinicalTrials.gov Identifier: NCT05651711
• Recruitment Status: Active, not recruiting
• First Posted: December 15, 2022
• Last Update Posted: January 8, 2024
• Sponsor: Amgen
• Information provided by (Responsible Party): Amgen

Tracking Information

• First Submitted Date: December 7, 2022
• First Posted Date: December 15, 2022
• Last Update Posted Date: January 8, 2024
• Actual Study Start Date: December 14, 2022
• Estimated Primary Completion Date: July 5, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 5, 2024)

• 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 [ Time Frame: Baseline and Week 24 ]
• Achievement of ≥ 75% Reduction From Baseline in EASI Score (EASI 75) at Week 24 [ Time Frame: Baseline and Week 24 ]

Original Primary Outcome Measures (submitted: December 7, 2022)

• 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 [ Time Frame: Baseline and Week 24 ]
• Achievement of ≥ 75% Reduction From Baseline in EASI Score (EASI 75) at Week 24 [ Time Frame: Baseline and Week 24 ]

Current Secondary Outcome Measures (submitted: January 5, 2024)

• Achievement of EASI 75 at Week 16 [ Time Frame: Baseline and Week 16 ]
• Achievement of vIGA-AD 0/1 at Week 16 [ Time Frame: Baseline and Week 16 ]
• 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 and Week 16 ]
• 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 and Week 24 ]
• Achievement of ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24 [ Time Frame: Baseline and Week 24 ]
• 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 [ Time Frame: Baseline to Week 24 ]
• 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 [ Time Frame: Baseline and Week 24 ]
• Achievement of a Facial AD Severity Score of Clear at Week 24 for Participants with Facial AD at Baseline [ Time Frame: Baseline and Week 24 ]
• Achievement of a Hand AD Severity Score of Clear at Week 24 for Participants with Hand AD at Baseline [ Time Frame: Baseline and Week 24 ]
• Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16 [ Time Frame: Baseline and Week 16 ]
• Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 [ Time Frame: Baseline and Week 24 ]
• Change from Baseline in SCORing Atopic Dermatitis (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16 [ Time Frame: Baseline and Week 16 ]
• Change From Baseline in SCORAD Itch VAS Score at Week 24 [ Time Frame: Baseline and Week 24 ]
• Achievement of a ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants with Baseline DLQI ≥ 4 [ Time Frame: Baseline and Week 24 ]
• Change From Baseline in DLQI Score at Week 24 [ Time Frame: Baseline and Week 24 ]
• 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 and Week 24 ]
• Change from Baseline in POEM Score at Week 24 [ Time Frame: Baseline and Week 24 ]
• 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 [ Time Frame: Baseline to Week 16 ]
• Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24 [ Time Frame: Baseline to Week 24 ]
• Change from Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 [ Time Frame: Baseline and Week 16 ]
• 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 [ Time Frame: Baseline to Week 24 ]
• 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 [ Time Frame: Baseline to Week 16 ]
• Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24 [ Time Frame: Baseline to Week 24 ]
• Achievement of 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 and Week 24 ]
• Achievement of HADS-depression Subscale Score <8 at Week 24 in Participants with Baseline HADS-depression Subscale Score ≥ 8 [ Time Frame: Baseline and Week 24 ]
• Change From Baseline in HADS-anxiety Subscale Score at Week 24 [ Time Frame: Baseline and Week 24 ]
• Change From Baseline in HADS-depression Subscale Score at Week 24 [ Time Frame: Baseline and Week 24 ]
• 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 and Week 24 ]

Original Secondary Outcome Measures (submitted: December 7, 2022)

• Achievement of EASI 75 at Week 16 [ Time Frame: Baseline and Week 16 ]
• Achievement of vIGA-AD 0/1 at Week 16 [ Time Frame: Baseline and Week 16 ]
• 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 and Week 16 ]
• 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 and Week 24 ]
• Achievement of ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24 [ Time Frame: Baseline and Week 24 ]
• Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24 [ Time Frame: Baseline to Week 24 ]
• Achievement of vIGA-AD 0/1 and Presence of Barely Perceptible Erythema or No Erythema at Week 24 [ Time Frame: Baseline and Week 24 ]
• Achievement of a Facial AD Severity Score of Clear at Week 24 for Participants with Facial AD at Baseline [ Time Frame: Baseline and Week 24 ]
• Achievement of a Hand AD Severity Score of Clear at Week 24 for Participants with Hand AD at Baseline [ Time Frame: Baseline and Week 24 ]
• Achievement of a Genital AD Severity Score of Clear at Week 24 for Participants with Genital AD at Baseline [ Time Frame: Baseline and Week 24 ]
• Change from Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16 [ Time Frame: Baseline and Week 16 ]
• Change from Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 [ Time Frame: Baseline and Week 24 ]
• Change from Baseline in SCORing Atopic Dermatitis (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16 [ Time Frame: Baseline and Week 16 ]
• Change from Baseline in SCORAD Itch VAS Score at Week 24 [ Time Frame: Baseline and Week 24 ]
• Achievement of a ≥ 4-point Reduction from Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants with Baseline DLQI ≥ 4 [ Time Frame: Baseline and Week 24 ]
• Change from Baseline in DLQI Score at Week 24 [ Time Frame: Baseline and Week 24 ]
• 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 and Week 24 ]
• Change from Baseline in POEM Score at Week 24 [ Time Frame: Baseline and Week 24 ]
• Change from Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 [ Time Frame: Baseline to Week 16 ]
• Change From Baseline in Weekly Average of Sleep Disturbance NRS Score at Week 24 [ Time Frame: Baseline to Week 24 ]
• Achievement of 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 and Week 24 ]
• Achievement of HADS-depression Subscale Score <8 at Week 24 in Participants with Baseline HADS-depression Subscale Score >/=8 [ Time Frame: Baseline and Week 24 ]
• Change from Baseline in HADS-anxiety Subscale Score at Week 24 [ Time Frame: Baseline and Week 24 ]
• Change from Baseline in HADS-depression Subscale Score at Week 24 [ Time Frame: Baseline and Week 24 ]
• Achievement of a ≥ 8.7-point Reduction from Baseline in Severity Scoring of Atopic Dermatitis (SCORAD) Score at Week 24 in Participants with Baseline SCORAD Score ≥ 8.7 [ Time Frame: Baseline and Week 24 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)
• Official 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)

Brief Summary

The co-primary objectives of the study are to:

• Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD).
• Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Eczema Area and Severity Index (EASI).

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Atopic Dermatitis

Intervention

• Drug: Rocatinlimab
  Rocatinlimab will be administered through a subcutaneous (SC) injection.
  Other Names:

  • AMG 451
  • KHK 4083
• Other: Placebo
  The matching placebo will be administered through a SC injection.

Study Arms

• Experimental: Rocatinlimab
  Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.
  Intervention: Drug: Rocatinlimab
• Placebo Comparator: Placebo
  Placebo Q4W for 24 weeks with a loading dose at Week 2.
  Intervention: Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: January 5, 2024): 726
• Original Estimated Enrollment (submitted: December 7, 2022): 680
• Estimated Study Completion Date: September 26, 2024
• Estimated Primary Completion Date: July 5, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 100 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Belgium, Brazil, Canada, Czechia, Denmark, Estonia, Finland, Germany, Japan, Korea, Republic of, Mexico, Poland, Portugal, Romania, South Africa, Spain, Sweden, Turkey, United Kingdom, United States

Administrative Information

• NCT Number: NCT05651711
• Other Study ID Numbers: 20210143; 2022-501538-44 ( Other Identifier: EU CT Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

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
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: 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

• Current Responsible Party: Amgen
• Original Responsible Party: Same as current
• Current Study Sponsor: Amgen
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: MD; Amgen

• PRS Account: Amgen
• Verification Date: January 2024