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Phase 3, 52-week Study Evaluating Rocatinlimab (AMG451)in Adolescent Subjects With Moderate-to-severe AD (ROCKET-ASTRO)
EU CTIS ID: 2022-501586-50-00
What this study is testing
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)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Taiwan
- Japan
- Canada
- United States
- China
- Thailand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; Taiwan; Japan; Canada; United States; China and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.