2022-501538-44-00CompletedPhase 3

A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe AD (ROCKET-Horizon)

A Phase 3, Randomized, 24-week, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety and Tolerability of Rocatinlimab (AMG 451) Monotherapy in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)

Source: EU CTIS (euclinicaltrials.eu) · Last updated 17 Jun 2025

Next steps

Brief summary (registry, in English)

To compare the effect of rocatinlimab with placebo at week 24, using Validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD)(TM) To compare the effect of rocatinlimab with placebo at week 24, using Eczema Area and Severity Index (EASI)

Status (registry): Completed
Phase (registry): Phase 3
Study type: Interventional
Enrollment: 234 (actual)
First submitted: 21 Nov 2022
Start date: 25 Apr 2023
Lead sponsor: Amgen Inc.
Diseases: Atopic dermatitis (eczema)
EU CT number: 2022-501538-44-00

What you commit to

Study type: Interventional · Phase 3
Participants enrolled: 234
57 sites in 11 countries
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Treatment with 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 1 week, prior to Day 1:• TCS of any potency • TCI • Topical phosphodiesterase type 4 (PDE4) inhibitors • Other topical immunosuppressive agents • Combination agents including TCS of any potency or TCI, PDE4 inhibitors, or other immunosuppressive agents
Treatment with any of the following medications or therapies within 1 week, prior to Day 1: • Topical phosphodiesterase type 4 (PDE4) inhibitors • Other topical immunosuppressive agents • Combination agents including PDE4 inhibitors, or other immunosuppressive agents

Who the study is looking for

Age ≥ 18 years with a diagnosis of AD according to the AAD Consensus Criteria (2014) present for at least 12 months
History of inadequate response to certain previous medications for the treatment of atopic dermatitis
EASI score ≥16
vIGA-AD score ≥3
Worst pruritus numerical rating scale ≥ 4

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (57)

Sites in registry order. Save your city in your profile to sort them by distance.

Site	City	Country	Site status
Hopital Erasme	Anderlecht	Belgium	Completed
Fonds et Services Sociaux Reseau Solidaris	Herstal	Belgium	Completed
Associatie dermatologie Maldegem	Maldegem	Belgium	Completed
Nemocnice AGEL Nový Jičín a.s.	Nový Jičín	Czechia	Completed
Clinical Research Center s.r.o.	Pardubice	Czechia	Completed
Fakultni Nemocnice Plzen	Plzen 1	Czechia	Completed
CCR Prague s.r.o.	Prague 3	Czechia	Completed
Praglandia s.r.o.	Prague 5	Czechia	Completed
Thermalsole und Schwefelbad Bentheim GmbH	Bad Bentheim	Germany	Completed
CRS Clinical Research Services Management GmbH	Berlin	Germany	Completed
Hautzentrum Friedrichshain	Berlin	Germany	Completed
Klinikum Bielefeld gGmbH	Bielefeld	Germany	Completed
University Hospital Halle (Saale)	Halle Saale	Germany	Completed
Dermatologikum Hamburg Gmbh	Hamburg	Germany	Completed
University Medical Centre Schleswig-Holstein	Kiel	Germany	Completed
Velocity Clinical Research Germany GmbH	Leipzig	Germany	Completed
Westfaelische Wilhelms Universitaet Muenster	Münster	Germany	Completed
Klinische Forschung Osnabrueck	Osnabrück	Germany	Completed
Hautarztpraxis Mortazawi GbR	Remscheid	Germany	Completed
Helios Universitaetsklinikum Wuppertal	Wuppertal	Germany	Completed
Gentofte Hospital	Hellerup	Denmark	Completed
Odense University Hospital	Odense C	Denmark	Completed
North Estonia Regional Hospital	Mustamae Linnaosa	Estonia	Completed
Tartu University Hospital	Tartu Linn	Estonia	Completed
Kliiniliste Uuringute Keskus OÜ	Tartu Linn	Estonia	Completed
Hospital General Universitario de Alicante	Alicante	Spain	Completed
Hospital Universitario Ramón y Cajal	Madrid	Spain	Completed
Hospital Universitario La Paz	Madrid	Spain	Completed
Hospital Universitario Puerta de Hierro de Majadahonda	Majadahonda	Spain	Completed
Hospital de Manises	Manises	Spain	Completed
Hospital Universitario Central De Asturias	Oviedo	Spain	Completed
University Clinic of Navarra	Pamplona	Spain	Completed
Hospital Universitario Virgen De La Macarena	Sevilla	Spain	Completed
Hospital Arnau de Vilanova de Valencia	Valencia	Spain	Completed
Suomen Terveystalo Oy	Helsinki	Finland	Completed
CRST Helsinki Oy	Helsinki	Finland	Completed
Oulu University Hospital	Oulu	Finland	Completed
Clinical Research Services Turku Oy	Turku	Finland	Completed
Clinicmed Daniluk Nowak Sp. k.	Bialystok	Poland	Completed
DERMAPOLIS Medical Dermatology Center dr n. med. Edyta Gębska	Chorzów	Poland	Completed
Centermed Krakow Sp. z o.o.	Cracow	Poland	Completed
Uniwersyteckie Centrum Kliniczne	Gdansk	Poland	Completed
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.	Lodz	Poland	Completed
Amicare Sp. z o.o. S.K.	Lodz	Poland	Completed
Appletreeclinics Network Sp. z o.o.	Lodz	Poland	Completed
Clinical Best Solutions Sp. z o.o. S.K.	Lublin	Poland	Completed
Clinical Research Center Sp z o o Medic R Sp k	Poznan	Poland	Completed
Klinika Osipowicz & Turkowski Sp. z o.o.	Warsaw	Poland	Completed
Clinical Best Solutions Sp. z o.o. S.K.	Warsaw	Poland	Completed
Evimed Sp. z o.o.	Warsaw	Poland	Completed
Hospital Garcia De Orta E.P.E.	Almada	Portugal	Completed
Centro Hospitalar E Universitărio de Coimbra E.P.E.	Coimbra	Portugal	Completed
Hospital Cuf Descobertas S.A.	Lisbon	Portugal	Completed
Centro Hospitalar Universitario Do Porto E.P.E.	Porto	Portugal	Completed
Sao Joao University Hospital Center	Porto	Portugal	Completed
Spitalul Clinic Colentina Bucuresti	Bucharest	Romania	Completed
Karolinska University Hospital	Solna	Sweden	Completed

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This page is information, not medical advice. Discuss any trial with your doctor.