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Completed

NCT Number: NCT05704738

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

The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy and combination therapy treatment in adolescent participants.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hopital Erasme, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Systemic corticosteroids
  • Non-biologic, non-targeted 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 4 inhibitors
  • Other topical immunosuppressive agents

Treatment and study plan

Rocatinlimab

Drug

Subcutaneous (SC) injection

Other names: AMG 451

Placebo

Drug

SC injection

Primary outcomes

  1. 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

  2. Achievement of ≥ 75% Reduction From Baseline in EASI Score (EASI 75) at Week 24

    Time frame: Baseline and Week 24

Secondary outcomes

  1. Achievement of EASI 75 at Week 16

    Time frame: Baseline and Week 16

  2. Achievement of a vIGA-AD 0/1 at Week 16

    Time frame: Baseline and 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 and 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 and Week 24

  5. Achievement of ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24

    Time frame: Baseline and 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 and Week 24

  7. 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

  8. Initiation of rescue therapy for AD at or before Week 16

    Time frame: Baseline to Week 16

  9. Initiation of rescue therapy for AD at or before Week 24

    Time frame: Baseline to Week 24

  10. Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16

    Time frame: Baseline to Week 16

  11. Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24

    Time frame: Baseline to Week 24

  12. Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) Itch Visual Analog Scale (VAS) Score at Week 16

    Time frame: Baseline to Week 16

  13. Change From Baseline in SCORAD Itch VAS Score at Week 24

    Time frame: Baseline to Week 24

  14. Achievement of a ≥ 4-point Reduction from Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants with Baseline DLQI ≥ 4 in Participants ≥ 16 Years of Age at Enrollment

    Time frame: Baseline and Week 24

  15. Change From Baseline in DLQI Score at Week 24 in Participants ≥ 16 Years of Age at Enrollment

    Time frame: Baseline to Week 24

  16. Change From Baseline in CDLQI Score at Week 24 in Participants < 16 Years of Age at Enrollment

    Time frame: Baseline to Week 24

  17. 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

  18. Change From Baseline in POEM Score at Week 24

    Time frame: Baseline to Week 24

  19. Achievement of a ≥ 4-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants with Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 4

    Time frame: Baseline and Week 16

  20. Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24

    Time frame: Baseline and Week 24

  21. Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16

    Time frame: Baseline and Week 16

  22. Achievement of a ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24 in Participants with Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3

    Time frame: Baseline and Week 24

  23. Achievement of a ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants with Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3

    Time frame: Baseline and Week 16

  24. Change From Baseline in Weekly Average of Sleep Disturbance NRS Score at Week 24

    Time frame: Baseline to Week 24

  25. 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

  26. Change From Baseline in HADS-anxiety Subscale Score at Week 24

    Time frame: Baseline to Week 24

  27. 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

  28. Change From Baseline in HADS-depression Subscale Score at Week 24

    Time frame: Baseline to Week 24

  29. 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

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Phase 3, Randomized, 52-week, Placebo-controlled, Double-blind Study With Re-randomization to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASTRO)

Acronym: ROCKET-ASTRO

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 30, 2023
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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