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Completed

NCT Number: NCT05633355

A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.

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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

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 ≥ 12 to < 18 years at day 1.
  • Participant has a diagnosis of AD (according to American Academy of Dermatology Consensus Criteria [Eichenfield, 2014]) that has been present for at least 12 months before signing of informed consent
  • Prior to informed consent, history of inadequate response to topical corticosteroids (TCS) of medium to 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)
  • Eczema Area and Severity Index (EASI) score ≥ 12
  • vIGA-AD score ≥ 3
  • ≥ 10% BSA of AD involvement at day 1 pre-enrollment

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 agents within 1 week before day 1 pre-enrollment:
  • Topical PDE4 inhibitors
  • Other topical immunosuppressive agents (not including TCS/TCI)
  • Combination topical agents containing a high- or super-high potency corticosteroid

Treatment and study plan

Rocatinlimab

Drug

Subcutaneous (SC) injection

Other names: AMG 451

Primary outcomes

  1. Number of Participants Who Experienced Treatment-emergent Serious Adverse Events (TESAEs)

    Time frame: From first dose of trial intervention to end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks

    An adverse event (AE) was any untoward medical occurrence in a clinical trial participant irrespective of a causal relationship with the study treatment.

    A SAE was defined as any untoward medical occurrence that meets at least 1 of the following serious criteria: resulted in death (fatal), was immediately life-threatening, required in-patient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or other medically important serious event. A TESAE was defined as an SAE that occurred on or after the first dose of trial intervention.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Phase 3, Open-label, 52-week Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab (AMG 451) in Adolescent Subjects Aged ≥ 12 to < 18 Years With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Orbit)

Acronym: ROCKET-Orbit

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 1, 2022
Registry last updated
Jul 24, 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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