A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe AD (ROCKET-Horizon)
Key facts
- Where
- Bad Bentheim, Berlin, Bielefeld, Halle Saale, Hamburg, Kiel, Leipzig, Münster, Osnabrück, Remscheid és Wuppertal, NémetországSee the 12 sites
- Phase
- 3. fázis
Where in Németország
- Thermalsole und Schwefelbad Bentheim GmbHBad Bentheim, NémetországNo longer taking part
- CRS Clinical Research Services Management GmbHBerlin, NémetországNo longer taking part
- Hautzentrum FriedrichshainBerlin, NémetországNo longer taking part
- Klinikum Bielefeld gGmbHBielefeld, NémetországNo longer taking part
- University Hospital Halle (Saale)Halle Saale, NémetországNo longer taking part
- Dermatologikum Hamburg GmbhHamburg, NémetországNo longer taking part
- University Medical Centre Schleswig-HolsteinKiel, NémetországNo longer taking part
- Velocity Clinical Research Germany GmbHLeipzig, NémetországNo longer taking part
- Westfaelische Wilhelms Universitaet MuensterMünster, NémetországNo longer taking part
- Klinische Forschung OsnabrueckOsnabrück, NémetországNo longer taking part
- Hautarztpraxis Mortazawi GbRRemscheid, NémetországNo longer taking part
- Helios Universitaetsklinikum WuppertalWuppertal, NémetországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Amgen Inc.
- Trial code
- EU 2022-501538-44-00
- Record updated
- 2025. június 17.
- Original description
To compare the effect of rocatinlimab with placebo at week 24, using Validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD)(TM)Read full original descriptionShow less
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)
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)
Inclusion: 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.
Exclusion: 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.