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Completed

NCT Number: NCT05724199

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

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).

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cinme - Centro de Investigaciones Metabolicas, CABA, Buenos Aires, Argentina

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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 ≥ 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

Treatment and study plan

Rocatinlimab

Drug

Subcutaneous (SC) injection

Other names: AMG 451

Placebo

Other

SC injection

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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)

Acronym: ROCKET-SHUTTLE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 13, 2023
Registry last updated
Nov 24, 2025

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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