In short
Clinical trials are investigating Rocatinlimab in people with moderate-to-severe atopic dermatitis, prurigo nodularis, and moderate-to-severe asthma. These studies look at safety, tolerability, and how well the treatment works compared with placebo. Most trials are phase 3, with one phase 2 asthma study.
Key points
- Clinical trials of Rocatinlimab are studying moderate-to-severe atopic dermatitis, prurigo nodularis, and moderate-to-severe asthma. Most of the studies are phase 3, with one phase 2 asthma trial. The atopic dermatitis trials compare Rocatinlimab with placebo and measure skin clearance and eczema improvement. The prurigo nodularis trial focuses on itch reduction. One trial is in adolescents with atopic dermatitis, and the source data includes authorised, completed, and withdrawn studies.
Clinical trials overview
The source data shows several interventional studies of Rocatinlimab in different diseases. Most of the trials are phase 3 studies, and one is a phase 2 study in asthma.
The listed studies include authorised, completed, and withdrawn trials. The main target populations are people with moderate-to-severe atopic dermatitis, adolescents with atopic dermatitis, people with prurigo nodularis, and people with moderate-to-severe asthma.
Atopic dermatitis studies
Several trials study atopic dermatitis, which is a long-term itchy skin condition also called eczema in the trial descriptions. These studies look at whether Rocatinlimab can improve skin signs and symptoms compared with placebo, which is an inactive treatment used for comparison.
The ROCKET-Ignite study was a phase 3, placebo-controlled, double-blind study of Rocatinlimab monotherapy in moderate-to-severe atopic dermatitis. It was completed and enrolled 775 people. Its main endpoints were clear or almost clear skin at week 24 using vIGA-AD and at least 75% improvement in eczema severity using EASI at week 24.
The ROCKET-Horizon study was also a phase 3, placebo-controlled, double-blind study in moderate-to-severe atopic dermatitis. It was completed and enrolled 708 people. This study compared Rocatinlimab with placebo and used the same kinds of skin-clearance and eczema-improvement outcomes at week 24.
The ROCKET-SHUTTLE study was another phase 3 study in moderate-to-severe atopic dermatitis, but it tested Rocatinlimab together with topical corticosteroids and/or topical calcineurin inhibitors. It was completed and enrolled 715 people. Its main goals were to see whether more people had clear or almost clear skin and whether eczema improved by 75% at week 24.
The ROCKET-ASCEND study is a phase 3 maintenance study in moderate-to-severe atopic dermatitis. It is authorised and has a planned enrolment of 2200 people. The brief summary says it is designed to describe the long-term safety and tolerability of Rocatinlimab in this population.
The ROCKET-Orbit study was a phase 3 study in adolescents with moderate-to-severe atopic dermatitis. It was withdrawn and planned to enrol 172 adolescents. Its primary outcome was treatment-emergent serious adverse events, meaning serious health problems that appear after treatment starts.
Prurigo nodularis study
One phase 3 study looks at prurigo nodularis, a skin condition with very itchy bumps or nodules. This study is placebo-controlled and double-blind, and it is authorised with an enrolment of 460 people.
The main outcome is the reduction in the weekly average daily itching score at set time points. In simple terms, the study wants to learn whether Rocatinlimab can lower itch more than placebo over time.
Asthma study
The asthma trial is a phase 2, double-blind, placebo-controlled, dose-ranging study in moderate-to-severe asthma. It is authorised and plans to enrol 428 people.
The main endpoint is the annualized asthma exacerbation rate during the placebo-controlled treatment period. The trial defines an exacerbation as worsening asthma that needs systemic corticosteroids for at least 3 days, an emergency department visit that leads to steroid use, or an inpatient hospitalization because of asthma.
Study designs and endpoints
Most studies are placebo-controlled, which means the results are compared with an inactive treatment to help show whether Rocatinlimab works better than no active study drug. Several are also double-blind, which means neither the participants nor the study team know who gets which treatment during the blinded part of the study.
In the atopic dermatitis studies, the main endpoints focus on skin clearance and eczema improvement at week 24 using vIGA-AD and EASI. In prurigo nodularis, the main endpoint is itch reduction, and in asthma, the main endpoint is fewer flare-ups over time.
Who can participate
The trial data show that the studies are aimed at people with moderate-to-severe disease in the condition being studied. This includes adults with atopic dermatitis, adolescents with atopic dermatitis in one withdrawn study, people with prurigo nodularis, and people with moderate-to-severe asthma.
Because the source data does not give full eligibility rules, the exact entry requirements are not listed here. The available information mainly shows the disease type, age group in one study, trial phase, and the main outcomes being measured.