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A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe AD (ROCKET-Horizon)
EU CTIS ID: 2022-501538-44-00
What this study is testing
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)
- 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
- 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
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- South Africa
- United Kingdom
- Japan
- Mexico
- Korea, Republic of
- Brazil
- Australia
- Canada
- United States
- Turkey
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include South Africa; United Kingdom; Japan; Mexico; Korea, Republic of; Brazil and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.