A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE) (NCT05398445) | Clinical Trial Compass
CompletedPhase 3
A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)
United States, Argentina, Brazil769 participantsStarted 2022-05-31
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy treatment.
Who can participate
Age range
18 Years – 100 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 ≥ 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 TCS (Topical Corticosteroid) of medium to higher potency (with or without topical calcineurin inhibitors \[TCI\]).
* EASI score ≥16
* vIGA-AD score ≥3
* ≥10% body surface area (BSA) of AD involvement
* Worst pruritus numerical rating scale ≥ 4
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
* Janus kinase inhibitors
* 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 inhibitors
* Other topical immunosuppressive agents
* Combination topical agents including TCS of any potency, TCI, PDE4 inhibitors, or other topical immunosuppressive agents
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.
1Since this is a completed Phase 3 trial measuring how many people achieved clear or nearly clear skin at 24 weeks, has my doctor seen any published results from ROCKET-IGNITE, and what do those results suggest about how well rocatinlimab worked compared to a placebo?
2The trial used two specific scales — the vIGA-AD score and a 75% reduction in the EASI score — to define success; can my doctor explain what those benchmarks mean in practical terms, like what my skin might actually look and feel like if I hit those targets?
3Rocatinlimab targets the OX40 receptor, which is a different mechanism than the biologics I may have already heard about for atopic dermatitis — can my doctor explain how this difference might matter for someone with my specific disease history or prior treatment experience?
4Since this trial is now completed and was a Phase 3 study, does my doctor know whether rocatinlimab has moved toward FDA approval, and would waiting for a potential approval be a reasonable option compared to treatments already available to me?
5This trial focused on moderate-to-severe atopic dermatitis, so can my doctor help me understand whether my current disease severity would have matched what was studied, and whether the safety profile seen in the trial raises any concerns given my overall health?
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 Achieved Validated Investigator's Global Assessment for AD (vIGA-AD) 1 Response With Presence of Only Barely Perceptible Erythema or vIGA-AD 0 Response (Revised Investigator's Global Assessment [rIGA] 0/1) at Week 24
Timeframe: Baseline and Week 24
2
Number of Participants Who Achieved ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 24