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Rocatinlimab

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.

Table of Contents

Clinical trials overview

The source data shows several interventional studies of Rocatinlimab in different diseases.[1] Most of the trials are phase 3 studies, and one is a phase 2 study in asthma.[1]

The listed studies include authorised, completed, and withdrawn trials.[1] The main target populations are people with moderate-to-severe atopic dermatitis, adolescents with atopic dermatitis, people with prurigo nodularis,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.[1]

Atopic dermatitis studies

Several trials study atopic dermatitis, which is a long-term itchy skin condition also called eczema in the trial descriptions.[1] These studies look at whether Rocatinlimab can improve skin signs and symptoms compared with placebo, which is an inactive treatment used for comparison.[1]

The ROCKET-Ignite study was a phase 3, placebo-controlled, double-blind study of Rocatinlimab monotherapy in moderate-to-severe atopic dermatitis.[1] It was completed and enrolled 775 people.[1] 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.[1]

The ROCKET-Horizon study was also a phase 3, placebo-controlled, double-blind study in moderate-to-severe atopic dermatitis.[1] It was completed and enrolled 708 people.[1] This study compared Rocatinlimab with placebo and used the same kinds of skin-clearance and eczema-improvement outcomes at week 24.[1]

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.[1] It was completed and enrolled 715 people.[1] Its main goals were to see whether more people had clear or almost clear skin and whether eczema improved by 75% at week 24.[1]

The ROCKET-ASCEND study is a phase 3 maintenance study in moderate-to-severe atopic dermatitis.[1] It is authorised and has a planned enrolment of 2200 people.[1] The brief summary says it is designed to describe the long-term safety and tolerability of Rocatinlimab in this population.[1]

The ROCKET-Orbit study was a phase 3 study in adolescents with moderate-to-severe atopic dermatitis.[1] It was withdrawn and planned to enrol 172 adolescents.[1] Its primary outcome was treatment-emergent serious adverse events, meaning serious health problems that appear after treatment starts.[1]

Prurigo nodularis study

One phase 3 study looks at prurigo nodularis, a skin condition with very itchy bumps or nodules.[1] This study is placebo-controlled and double-blind, and it is authorised with an enrolment of 460 people.[1]

The main outcome is the reduction in the weekly average daily itching score at set time points.[1] In simple terms, the study wants to learn whether Rocatinlimab can lower itch more than placebo over time.[1]

Asthma study

The asthma trial is a phase 2, double-blind, placebo-controlled, dose-ranging study in moderate-to-severe asthma.[1] It is authorised and plans to enrol 428 people.[1]

The main endpoint is the annualized asthma exacerbation rate during the placebo-controlled treatment period.[1] 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.[1]

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.[1] 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.[1]

In the atopic dermatitis studies, the main endpoints focus on skin clearance and eczema improvement at week 24 using vIGA-AD and EASI.[1] In prurigo nodularis, the main endpoint is itch reduction, and in asthma, the main endpoint is fewer flare-ups over time.[1]

Who can participate

The trial data show that the studies are aimed at people with moderate-to-severe disease in the condition being studied.[1] 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.[1]

Because the source data does not give full eligibility rules, the exact entry requirements are not listed here.[1] The available information mainly shows the disease type, age group in one study, trial phase, and the main outcomes being measured.[1]

Trial IDPhaseCondition studiedStatusEnrollment
NCT05882877Phase 3Moderate-to-severe atopic dermatitisAuthorised2200
2022-501585-22-00Phase 3Moderate-to-severe atopic dermatitisCompleted715
NCT06527404Phase 3Prurigo nodularisAuthorised460
2022-501535-16-00Phase 3Moderate-to-severe atopic dermatitis in adolescentsWithdrawn172
NCT05398445Phase 3Moderate-to-severe atopic dermatitisCompleted775
NCT06376045Phase 2Moderate-to-severe asthmaAuthorised428

FAQ

  • What conditions are being studied in Rocatinlimab trials? The trials in the source data study atopic dermatitis, prurigo nodularis, and moderate-to-severe asthma. Most of the research is in atopic dermatitis, which is a long-term itchy skin condition.
  • What phases are the Rocatinlimab trials? Most listed trials are phase 3 studies, which usually test how well a treatment works in larger groups of people. There is also one phase 2 study in moderate-to-severe asthma, which is looking at dose ranging and early efficacy.
  • Who can join Rocatinlimab trials? The trials are aimed at people with moderate-to-severe disease in the condition being studied. Some studies include adults with atopic dermatitis, one study includes adolescents with atopic dermatitis, and one study includes people with moderate-to-severe asthma.
  • What do the Rocatinlimab trials measure? In atopic dermatitis studies, the trials measure clear or almost clear skin and improvement in eczema scores at week 24. In asthma, the main measure is the annualized asthma exacerbation rate, which means how often asthma attacks happen over a year.
  • Are the Rocatinlimab studies all still ongoing? No. The source data includes authorised, completed, and withdrawn studies. This means some trials are finished, some are planned or active, and one adolescent atopic dermatitis study was withdrawn.

Ongoing Clinical Trials on Rocatinlimab

  • Study on Rocatinlimab for Adolescents Aged 12-17 with Moderate-to-Severe Atopic Dermatitis

    Not yet recruiting

    3 1 1 1
    Investigated drugs:
    Austria Denmark Finland Germany Hungary Italy +3

  • Study of Rocatinlimab in Adults with Prurigo Nodularis Not Adequately Controlled by Topical Treatments

    Not recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Finland France Germany Greece +9

  • Study on Rocatinlimab for Adults with Moderate-to-Severe Atopic Dermatitis

    Not recruiting

    3 1
    Investigated drugs:
    Croatia Czechia Germany Greece Hungary Italy +6

  • Study of Rocatinlimab with Topical Treatments for Adults with Moderate to Severe Atopic Dermatitis

    Not recruiting

    3 1 1
    Investigated drugs:
    Austria Belgium Bulgaria France Germany Greece +8

  • Study on Rocatinlimab for Adults with Moderate-to-Severe Atopic Dermatitis

    Not recruiting

    3 1
    Investigated drugs:
    Belgium Czechia Denmark Estonia Finland Germany +5

  • Study of Rocatinlimab compared to Placebo to help adults with Moderate to Severe Asthma

    Not recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia Hungary Poland Romania

Glossary

  • Atopic dermatitis: A long-term skin condition that causes dry, itchy, and inflamed skin. It is also called eczema in many trial descriptions.
  • Prurigo nodularis: A skin condition with very itchy, firm bumps or nodules. The main symptom studied in the trial is itching.
  • Asthma: A lung condition that can cause wheezing, shortness of breath, chest tightness, and coughing.
  • Moderate-to-severe: A description of disease intensity. It means the condition is more serious and may affect daily life a lot.
  • Phase 2: An early clinical trial phase that often looks at dose range, safety, and early signs of benefit.
  • Phase 3: A later trial phase that usually compares a treatment with placebo or standard care in larger groups to see how well it works and how safe it is.
  • Placebo: An inactive treatment used for comparison. It looks like the study treatment but does not contain the active study drug.
  • Double-blind: A study design where participants and study staff do not know who is getting the study treatment. This helps reduce bias.
  • Monotherapy: Treatment used by itself, without another study medicine as the main treatment.
  • Topical corticosteroids: Medicines applied to the skin to reduce inflammation.
  • Topical calcineurin inhibitors: Skin medicines used to reduce inflammation, often as an alternative or add-on treatment.
  • EASI: Eczema Area and Severity Index. This is a score used to measure how severe eczema is and how much it improves.
  • vIGA-AD: Validated Investigator’s Global Assessment for Atopic Dermatitis. This is a doctor-rated scale that checks whether the skin is clear or almost clear.
  • Annualized asthma exacerbation rate: A measure of how often asthma flare-ups happen over one year.
  • Exacerbation: A flare-up or worsening of a disease. In asthma, it can mean symptoms become bad enough to need extra treatment.
  • Enrolment: The number of people planned or included in a study.
  • Interventional study: A trial where researchers give a study treatment and compare outcomes.
  • Tolerability: How well people can take a treatment without too much trouble.

References

  1. https://clinicaltrials.gov/study/NCT05882877