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New shot could tame teen eczema

NCT ID NCT05633355

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 24, 2026 · Updated 2 times

Summary

This study tested a drug called rocatinlimab in 187 teenagers aged 12 to 17 with moderate-to-severe eczema that didn't respond well to standard creams. The goal was to see if the drug is safe and tolerable over 52 weeks. Participants received regular injections, and researchers tracked serious side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
rocatinlimab (AMG 451), a drug given as a shot under the skin
What this could lead to
If it works, this could offer a new treatment option for teenagers with hard-to-control eczema, potentially reducing flare-ups and itching.
What could go wrong
This is an open-label study without a placebo group, so results may be less reliable. Side effects are still being evaluated, and the drug may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

187 people

The number who actually took part.

Started

Jan 2023

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

atopic eczema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atopic dermatitis

Contacts and locations

Locations

  • ARA Professionals Limited Liability Corporation

    Miami, Florida, 33176, United States

  • Alder Hey Childrens Hospital

    Liverpool, L12 2AP, United Kingdom

  • Alergoalfa Nucleo Diagnostico Tratamento e Pesquisa Clinica em Alergia

    São Paulo, 06454-010, Brazil

  • Auni Allergy

    Findlay, Ohio, 45840, United States

  • Bakircay Universitesi Cigli Egitim ve Arastirma Hastanesi

    Izmir, 35620, Turkey (Türkiye)

  • Bezmialem Vakif Universitesi Hastanesi

    Istanbul, 34093, Turkey (Türkiye)

  • Bluegrass Allergy Care

    Lexington, Kentucky, 40509, United States

  • Bristol Royal Hospital for Children

    Bristol, BS2 8BJ, United Kingdom

  • Carn to Coast Health Centres

    Redruth, TR16 4ET, United Kingdom

  • Center for Clinical Studies

    Houston, Texas, 77004, United States

  • Centro de Investigaciones Clinicas Instituto Especialidades De La Salud De Rosario

    Rosario, Santa Fe Province, 2000, Argentina

  • Chung-Ang University Hospital

    Seoul, 06973, South Korea

  • Cinme - Centro de Investigaciones Metabolicas

    CABA, Buenos Aires, C1027AAP, Argentina

  • Deluxe Health Care LLC

    Miami Lakes, Florida, 33014, United States

  • DermDox Dermatology, LLC

    Sugarloaf, Pennsylvania, 18249, United States

  • Dermatology Research Associates

    Los Angeles, California, 90045, United States

  • Dermatology Research Institute Incorporated

    Calgary, Alberta, T2J 7E1, Canada

  • Dermatology Trial Associates

    Bryant, Arkansas, 72022, United States

  • Driscoll Childrens Hospital

    Corpus Christi, Texas, 78411, United States

  • Erciyes Universitesi Tip Fakultesi Hastanesi

    Kayseri, 38030, Turkey (Türkiye)

  • Ewha Womans University Seoul Hospital

    Seoul, 07804, South Korea

  • FACET Dermatology

    Toronto, Ontario, M4E 1R7, Canada

  • Fundacao Abc - Centro Univ Fmabc

    Santo André, São Paulo, 09060-870, Brazil

  • Fundacion Cidea

    Buenos Aires, Distrito Federal, 1121, Argentina

  • Fundacion Estudios Clinicos

    Rosario, Santa Fe Province, 2000, Argentina

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul, 07441, South Korea

  • Halton Pediatric Allergy

    Burlington, Ontario, L7L 6W6, Canada

  • Hospital Ernesto Dornelles

    Porto Alegre, Rio Grande do Sul, 90160-093, Brazil

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Institute for Skin Health and Immunity

    Mitcham, Victoria, 3132, Australia

  • Instituto de Diagnostico ABC

    Rosario, Santa Fe Province, 2000, Argentina

  • Instituto de Neumonologia y Dermatologia

    Buenos Aires, Distrito Federal, 1425, Argentina

  • Ispem-Instituto São José dos Campos em Pesquisas Médicas

    São José dos Campos, São Paulo, 12243-280, Brazil

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi

    Istanbul, 34098, Turkey (Türkiye)

  • JRB Research Incorporated

    Ottawa, Ontario, K2C 3N2, Canada

  • Korea University Ansan Hospital

    Ansansi, Gyeonggido, 15355, South Korea

  • Kyung Hee University Hospital at Gangdong

    Seoul, 05278, South Korea

  • LEADER Research

    Hamilton, Ontario, L8L 3C3, Canada

  • Little Rock Allergy and Asthma Clinical Research Center

    Little Rock, Arkansas, 72205, United States

  • Liverpool Hospital

    Liverpool, New South Wales, 2170, Australia

  • Manlio Dermatology

    Kissimmee, Florida, 34741, United States

  • Medical Advancement Centers of Arizona

    Tempe, Arizona, 85283, United States

  • Modern Research Associates

    Dallas, Texas, 75231, United States

  • Monash Childrens Hospital

    Clayton, Victoria, 3168, Australia

  • National Medical Center

    Seoul, 04564, South Korea

  • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

    Samsun, 55200, Turkey (Türkiye)

  • Oregon Medical Research Center

    Portland, Oregon, 97201, United States

  • Palm Springs Community Health Center

    Miami, Florida, 33014, United States

  • Phoenix Childrens Hosptial

    Phoenix, Arizona, 85016, United States

  • Premier Specialists

    Kogarah, New South Wales, 2217, Australia

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065, Australia

  • SKiN Centre for Dermatology

    Peterborough, Ontario, K9J 5K2, Canada

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • SimcoDerm Medical and Surgical Dermatology Centre

    Barrie, Ontario, L4M 7G1, Canada

  • Skincare Studio

    St. John's, Newfoundland and Labrador, A1E 1V4, Canada

  • Smart Medical Research Inc

    Jackson Heights, New York, 11372, United States

  • Sociedade Beneficente de Senhoras Hospital Sirio Libanes

    São Paulo, São Paulo, 01308-050, Brazil

  • St Thomas Hospital

    London, SE1 7EH, United Kingdom

  • Stratica Dermatology

    Edmonton, Alberta, T5K 1X3, Canada

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591, South Korea

  • The Skin Centre

    Benowa, Queensland, 4217, Australia

  • The Skin Hospital

    Darlinghurst, New South Wales, 2010, Australia

  • Toronto Research Centre Inc

    Toronto, Ontario, M3H 5Y8, Canada

  • Triple A Lab

    Hamilton, Ontario, L8S 1G5, Canada

  • Universidade Federal do Parana

    Curitiba, Paraná, 80060-240, Brazil

  • University of California Irvine

    Irvine, California, 92697, United States

  • University of California Los Angeles

    Los Angeles, California, 90024, United States

  • University of Hong Kong, Queen Mary Hospital

    Hong Kong, Hong Kong

  • University of Utah MidValley Dermatology

    Murray, Utah, 84107, United States

  • Velocity Clinical Research, High Wycombe

    High Wycombe, HP11 2QW, United Kingdom

  • Veracity Clinical Research

    Woolloongabba, Queensland, 4102, Australia

  • Vida Clinical Research

    Edmonton, Alberta, T6H 4J8, Canada

  • Whipps Cross University Hospital

    London, E11 1NR, United Kingdom

  • Windsor Dermatology dba Eczema Treatment Center of New Jersey

    East Windsor, New Jersey, 08520, United States

  • Winnipeg Clinic Dermatology Research

    Winnipeg, Manitoba, R3C 0N2, Canada

  • Woden Dermatology

    Phillip, Australian Capital Territory, 2606, Australia

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