Phase 3, 52-week Study Evaluating Rocatinlimab (AMG451)in Adolescent Subjects With Moderate-to-severe AD (ROCKET-ASTRO)
Key facts
- Where
- Budapest III, Debrecen és Kaposvár, MagyarországSee the 4 sites
- Phase
- 3. fázis
Where in Magyarország
- Clinexpert Kft.Budapest III, MagyarországNo longer taking part
- Derma-B Kft.Debrecen, MagyarországNo longer taking part
- University of DebrecenDebrecen, MagyarországNo longer taking part
- Somogy Megyei Kaposi Mór Oktató KórházKaposvár, MagyarországNo 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 2022-501586-50-00
- Record updated
- 2025. augusztus 29.
- Original description
To evaluate the efficacy of rocatinlimab compared with placebo at week 24 To evaluate the efficacy of rocatinlimab compared with placebo at week 24, assessed using Eczema Area and Severity Index (EASI)Read full original descriptionShow less
A Phase 3, Randomized, 52-week, Placebo-controlled, Double-blind Study With Rerandomization to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASTRO)
To evaluate the efficacy of rocatinlimab compared with placebo at week 24 To evaluate the efficacy of rocatinlimab compared with placebo at week 24, assessed using Eczema Area and Severity Index (EASI)
Inclusion: Males and females age ≥12 to <18 years at day 1 with a diagnosis of AD (according to American Academy of Dermatology Consensus Criteria; Eichenfield et al, 2014), that has been present for at least 12 months before signing of informed consent; Prior to informed consent, history of inadequate response to TCS of medium to higher potency (with or without TCI as appropriate) or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks). Inadequate response is defined as failure to achieve and maintain remission or a low disease activity state (comparable to pre-determined score) despite treatment with a daily regimen of TCS of medium to higher potency (±TCI as appropriate), applied for at least 28 days or for maximum duration recommended by the product prescribing information (eg, 14 days for super-high potent TCS), whichever is shorter. Subjects with previous systemic treatment for AD are also considered as inadequate responders to topical treatments and are potentially eligible to be included in the study after appropriate washout; Presence of moderate-to-severe AD at both initial screening and day 1 prerandomization visit, (on the pre-determined score) Additionally, EASI score ≥ 12 at initial screening and EASI score ≥ 16 at day 1 prerandomization; patient-reported worst pruritus NRS pre-determined score based on a single-question item with 7-day recall is required at initial screening.
Exclusion: 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, Janus kinase inhibitors; Treatment with any of the following medications or therapies within 1 week, prior to Day 1: Topical Corticosteroids, Topical Calcineurin Inhibitors, Topical phosphodiesterase type 4 inhibitors, Other topical immunosuppressive agents.