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A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab Monotherapy in Moderate-to-severe AD (ROCKET-Ignite)
EU CTIS ID: 2022-501540-15-00
What this study is testing
To evaluate the efficacy of rocatinlimab compared with placebo at week 24, assessed using the Validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD ™) 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 or females aged ≥ 18 years or legal adult age within subject’s country, whichever is older, 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 or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks)
- Presence of moderate-to-severe AD at both initial screening and day 1 prerandomization visit, defined as EASI score ≥ 16, vIGA-AD score ≥ 3 (on the 0 to 4 vIGA-AD scale, in which 3 is moderate and 4 is severe) and ≥ 10% body surface area (BSA) of AD involvement. Additionally, patient-reported worst pruritus NRS >/= 4 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 immunosuppressive or immunomodulatory therapy for AD or any other autoimmune, inflammatory, or allergic condition within 12 weeks or 5 half lives, whichever is longer, prior to day 1 prerandomization.
- Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to day 1 prerandomization. -Systemic corticosteroids (inhaled corticosteroids, intra-articular steroid injection, eye, ear, or nasal drops containing corticosteroids are allowed, suppositories, or enemas containing corticosteroids are not allowed) -Systemic treatment with methotrexate, mycophenolate/mycophenolate mofetil, calcineurin inhibitors, thalidomide, or other non-biologic, non-targeted systemic immunosuppressants -Phototherapy -Oral or topical JAK inhibitors
- Treatment with any of the following agents within 1 week before day 1 prerandomization: -Topical phosphodiesterase type 4 (PDE4) inhibitors -Other topical immunosuppressive agents -Combination topical agents including PDE4 inhibitors, or other topical immunosuppressive agents
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Korea, Republic of
- United States
- Argentina
- Japan
- China
- Brazil
- Taiwan
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 Canada; Korea, Republic of; United States; Argentina; Japan; China and 2 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.