A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participan… (NCT05633355) | Clinical Trial Compass
CompletedPhase 3
A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
United States, Argentina, Australia187 participantsStarted 2023-01-30
Plain-language summary
The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.
Who can participate
Age range
12 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 12 to \< 18 years at day 1.
* Participant has a diagnosis of AD (according to American Academy of Dermatology Consensus Criteria \[Eichenfield, 2014\]) that has been present for at least 12 months before signing of informed consent
* Prior to informed consent, history of inadequate response to topical corticosteroids (TCS) of medium to higher potency (with or without topical calcineurin inhibitors \[TCI\] as appropriate) or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks)
* Eczema Area and Severity Index (EASI) score ≥ 12
* vIGA-AD score ≥ 3
* ≥ 10% BSA of AD involvement at day 1 pre-enrollment
Exclusion Criteria:
* 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
* Oral or topical janus kinase inhibitors
* Treatment with any of the following agents within 1 week before day 1 pre-enrollment:
* Topical PDE4 inhibitors
* Other topical immunosuppressive agents (not including TCS/TCI)
* Combination topical agents containing a high- or super-high potency corticosteroid
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Who Experienced Treatment-emergent Serious Adverse Events (TESAEs)
Timeframe: From first dose of trial intervention to end of trial; median (min, max) duration was 52.1 (2.0, 70.1) weeks