A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASTRO)

• ClinicalTrials.gov Identifier: NCT05704738
• Recruitment Status: Recruiting
• First Posted: January 30, 2023
• Last Update Posted: May 16, 2024
• Sponsor: Amgen
• Information provided by (Responsible Party): Amgen

Tracking Information

• First Submitted Date: January 20, 2023
• First Posted Date: January 30, 2023
• Last Update Posted Date: May 16, 2024
• Actual Study Start Date: April 20, 2023
• Estimated Primary Completion Date: September 26, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 10, 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: January 20, 2023)

• Achievement of a Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) Score of 0 or 1 with a ≥2 Point Reduction From Baseline at Week 24 [ Time Frame: Baseline and Week 24 ]
• Achievement of ≥ 75% Reduction in Eczema Area and Severity Index (EASI) Score From Baseline (EASI 75) at Week 24 [ Time Frame: Baseline and Week 24 ]

Current Secondary Outcome Measures (submitted: April 10, 2024)

• Achievement of EASI 75 at Week 16 [ Time Frame: Baseline and Week 16 ]
• Achievement of a 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 Partiipants 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 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 and Week 24 ]
• Achievement of a vIGA-AD Score of 1 with Presence of Only Barely Perceptible Erythema or vIGA-AD Score of 0 (revised Investigator's Global Assessment [rIGA™] 0/1) at Week 24 [ Time Frame: Baseline and Week 24 ]
• Initiation of rescue therapy for AD at or before Week 16 [ Time Frame: Baseline to Week 16 ]
• Initiation of rescue therapy for AD at or before Week 24 [ Time Frame: Baseline to Week 24 ]
• Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16 [ Time Frame: Baseline to Week 16 ]
• Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 [ Time Frame: Baseline to Week 24 ]
• Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) Itch Visual Analog Scale (VAS) Score at Week 16 [ Time Frame: Baseline to Week 16 ]
• Change From Baseline in SCORAD Itch VAS Score at Week 24 [ Time Frame: Baseline to 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 (Children's Dermatology Life Quality Index [CDLQI] in Participants < 16 Years of Age at Screening) [ Time Frame: Baseline and Week 24 ]
• Change From Baseline in DLQI or CDLQI Score at Week 24 [ Time Frame: Baseline to 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 to Week 24 ]
• 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 and Week 16 ]
• Change From Baseline in Weekly Average of Daily AD Skin Pain NRS 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 and Week 16 ]
• 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 and Week 24 ]
• 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 and Week 16 ]
• Change From Baseline in Weekly Average of Sleep Disturbance NRS Score at Week 24 [ Time Frame: Baseline to Week 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 and Week 24 ]
• Change From Baseline in HADS-anxiety Subscale Score at Week 24 [ Time Frame: Baseline to Week 24 ]
• Achievement of a 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-depression Subscale Score at Week 24 [ Time Frame: Baseline to Week 24 ]
• Achievement of a ≥ 8.7-point Reduction from Baseline in Severity SCORAD Score at Week 24 in Participants with Baseline SCORAD Score ≥ 8.7 [ Time Frame: Baseline and Week 24 ]

Original Secondary Outcome Measures (submitted: January 20, 2023)

• Achievement of ≥ 75% Reduction From Baseline in EASI Score at Week 16 [ Time Frame: Baseline and Week 16 ]
• Achievement of a vIGA-AD Score of 0 or 1 with a ≥ 2-point Reduction From Baseline 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 Subjects 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 Subjects 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 a vIGA-AD Score of 0 or 1 with a ≥ 2-point Reduction From Baseline and Presence of Barely Perceptible Erythema or No Erythema at Week 24 [ Time Frame: Baseline and Week 24 ]
• Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16 [ Time Frame: Baseline to Week 16 ]
• Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 [ Time Frame: Baseline to Week 24 ]
• Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) Itch Visual Analog Scale (VAS) Score at Week 16 [ Time Frame: Baseline to Week 16 ]
• Change From Baseline in SCORAD Itch VAS Score at Week 24 [ Time Frame: Baseline to Week 24 ]
• Achievement of a ≥ 4-point Reduction from Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Subjects with Baseline DLQI ≥ 4 (Children's Dermatology Life Quality Index [CDLQI] in Subjects < 16 Years of Age) [ Time Frame: Baseline and Week 24 ]
• Change From Baseline in DLQI or CDLQI Score at Week 24 [ Time Frame: Baseline to Week 24 ]
• Achievement of a ≥ 4-point Reduction From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 24 in Subjects with Baseline POEM Score ≥ 4 [ Time Frame: Baseline and Week 24 ]
• Change From Baseline in POEM Score at Week 24 [ Time Frame: Baseline to Week 24 ]
• Change From Baseline in Weekly Average of Sleep Disturbance NRS Score at Week 24 [ Time Frame: Baseline to Week 24 ]
• Achievement of a Hospital Anxiety and Depression Scale (HADS)-anxiety Subscale Score < 8 at Week 24 in Subjects with Baseline HADS-anxiety Subscale Score ≥ 8 [ Time Frame: Baseline and Week 24 ]
• Change From Baseline in HADS-anxiety Subscale Score at Week 24 [ Time Frame: Baseline to Week 24 ]
• Achievement of a HADS-depression Subscale Score < 8 at Week 24 in Subjects with Baseline HADS-depression Subscale Score ≥ 8 [ Time Frame: Baseline and Week 24 ]
• Change From Baseline in HADS-depression Subscale Score at Week 24 [ Time Frame: Baseline to Week 24 ]
• Achievement of a ≥ 8.7-point Reduction from Baseline in Severity SCORAD Score at Week 24 in Subjects 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 to Evaluate Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD)
• Official Title: A Phase 3, Randomized, 52-week, Placebo-controlled, Double-blind Study With Rerandomization to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASTRO)
• Brief Summary: The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy and combination therapy treatment in adolescent subjects.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Sequential Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Atopic Dermatitis

Intervention

• Drug: Rocatinlimab
  Subcutaneous (SC) injection
  Other Name: AMG 451
• Drug: Placebo
  SC injection

Study Arms

• Experimental: Arm A: Dose 1

  Part 1 (Initial Period); Week 0 to Week 24: Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks with loading dose at Week 2 (+ topical corticosteroids (TCS)/ topical calcineurin inhibitor (TCI) if within combination therapy cohort).

  Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be rerandomised at Week 24 to Rocatinlimab Dose 1 Q4W or every 8 weeks (Q8W) for 28 weeks (+ TCS/TCI if within combination therapy cohort).

  Intervention: Drug: Rocatinlimab
• Experimental: Arm B: Dose 2

  Part 1 (Initial Period); Week 0 to Week 24: Rocatinlimab Dose 2 Q4W for 24 weeks with loading dose at Week 2 (+TCS/TCI if within combination therapy cohort).

  Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be rerandomised at Week 24 to Rocatinlimab Dose 2 Q4W or Q8W for 28 weeks (with TCS/TCI if within combination therapy cohort).

  Intervention: Drug: Rocatinlimab
• Experimental: Arm C: Placebo

  Part 1 (Initial Period); Week 0 to Week 24: Placebo Q4W for 24 weeks with loading dose at Week 2 (+TCS/TCI if within combination therapy cohort).

  Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be reassigned at Week 24 with Placebo Q4W for 28 weeks (with TCS/TCI if within combination therapy cohort).

  Intervention: Drug: Placebo
• Experimental: Arm D: Open-Label Dose 1
  Part 2; Week 24 to Week 52: Part 1 Non-Responders will be reassigned at Week 24 with Rocatinlimab Open-label Dose 1 Q4W for 28 weeks (with TCS/TCI if within combination therapy cohort). Participants in Arms A, B or C Maintenance Period will be reassigned with Rocatinlimab Open-label Dose 1 Q4W (with TCS/TCI if within combination therapy cohort) upon relapse after Week 24.
  Intervention: Drug: Rocatinlimab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 20, 2023): 500
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 18, 2025
• Estimated Primary Completion Date: September 26, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Age ≥ 12 to < 18 years at Day 1.
• Diagnosis of AD (according to American Academy of Dermatology Consensus Criteria [Eichenfield et al, 2014]) that has been present for at least 12 months before signing of informed consent.
• Body weight ≥ 40 kg at screening.
• History of inadequate response to TCS of medium to higher potency (with or without TCI).
• EASI score ≥ 12 at initial screening.
• EASI score ≥ 16 at Day 1.
• vIGA-AD score ≥ 3.
• ≥10% body surface area of AD involvement.
• Worst pruritus NRS ≥ 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:

  1. Systemic corticosteroids
  2. Non-biologic, non-targeted systemic immunosuppressants
  3. Phototherapy
  4. Oral or Topical Janus kinase inhibitors

• Treatment with any of the following medications or therapies within 1 week, prior to Day 1:

  1. TCS of any potency
  2. TCI
  3. Topical phosphodiesterase 4 inhibitors
  4. Other topical immunosuppressive agents

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years to 17 Years (Child)
• Accepts Healthy Volunteers: No

Contacts

Contact: Amgen Call Center; 866-572-6436; medinfo@amgen.com

• Listed Location Countries: Belgium, Brazil, Canada, Chile, China, Croatia, France, Germany, Greece, Hungary, Italy, Japan, Korea, Republic of, Poland, Puerto Rico, Romania, Spain, Taiwan, Thailand, United States

Administrative Information

• NCT Number: NCT05704738
• Other Study ID Numbers: 20210145; 2022-501586-50 ( Other Identifier: EUCTR )
• 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: May 2024