187 Participants Needed

Rocatinlimab for Eczema

(ROCKET-Orbit Trial)

Recruiting at 92 trial locations
AC
Overseen ByAmgen Call Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial tests the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe atopic dermatitis. Rocatinlimab works by reducing inflammation and calming the immune system.

Will I have to stop taking my current medications?

The trial requires you to stop certain medications before starting. You must stop biological products 12 weeks before, systemic corticosteroids, immunosuppressants, phototherapy, and janus kinase inhibitors 4 weeks before, and certain topical treatments 1 week before joining the trial.

What data supports the effectiveness of the drug Rocatinlimab for eczema?

Research shows that Rocatinlimab, an anti-OX40 antibody, was effective in reducing symptoms of moderate-to-severe eczema. In a clinical trial, patients treated with Rocatinlimab had a significant reduction in eczema severity compared to those who received a placebo.12345

Is rocatinlimab safe for humans?

Rocatinlimab, also known as KHK4083 or AMG-451, has been studied for safety in adults with moderate-to-severe atopic dermatitis (a type of eczema). The research evaluated its safety profile, but specific details on adverse effects were not provided in the available data.15678

What makes the drug Rocatinlimab unique for treating eczema?

Rocatinlimab is unique because it targets the OX40 pathway, which is involved in T-cell responses that contribute to eczema, offering a novel approach compared to other treatments that focus on different pathways.123910

Research Team

M

MD

Principal Investigator

Amgen

Eligibility Criteria

Adolescents aged 12 to under 18 with moderate-to-severe atopic dermatitis (AD) who haven't responded well to strong topical corticosteroids or when such treatments are not advised. Participants should have had AD for at least a year, an EASI score of ≥12, and more than 10% body surface area affected.

Inclusion Criteria

I am between 12 and 17 years old.
My skin condition didn't improve with strong creams in the last 6 months.
Topical treatments for my condition were either not effective or not suitable due to side effects.
See 4 more

Exclusion Criteria

I haven't taken any biological medicines for the last 12 weeks or 5 half-lives, whichever is longer.
I haven't taken steroids, immunosuppressants, had phototherapy, or used JAK inhibitors recently.
I haven't used certain skin medications in the week before joining.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Rocatinlimab is administered subcutaneously every 4 weeks for 52 weeks with one additional dose at Week 2

52 weeks
13 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Rocatinlimab
Trial OverviewThe trial is testing the safety and effectiveness of Rocatinlimab in adolescents with AD. It aims to see how well participants tolerate this medication and if it improves their skin condition compared to previous treatments they've tried.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: RocatinlimabExperimental Treatment1 Intervention
Rocatinlimab will be administered subcutaneously every 4 weeks (Q4W) for 52 weeks with one additional dose at Week 2.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials
1,508
Recruited
1,433,000+
Founded
1980
Headquarters
Thousand Oaks, USA
Known For
Human Therapeutics
Top Products
Enbrel, Prolia, Neulasta, Otezla
Robert A. Bradway profile image

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton profile image

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Findings from Research

In a phase 2b study involving 274 adults with moderate-to-severe atopic dermatitis, rocatinlimab significantly reduced Eczema Area and Severity Index (EASI) scores compared to placebo, with reductions of up to 61.1% observed at week 16 for the highest dose.
Rocatinlimab was generally well tolerated, with common side effects including pyrexia and nasopharyngitis, but no deaths were reported, indicating a favorable safety profile for this treatment.
An anti-OX40 antibody to treat moderate-to-severe atopic dermatitis: a multicentre, double-blind, placebo-controlled phase 2b study.Guttman-Yassky, E., Simpson, EL., Reich, K., et al.[2023]
Rocatinlimab and amlitelimab, two inhibitors targeting the OX40-OX40L pathway, showed significant efficacy in reducing atopic dermatitis symptoms in clinical trials, with rocatinlimab achieving a reduction of 48.3% to 61.1% in the EASI score compared to a placebo reduction of 15.0%.
Both treatments were found to be safe and well tolerated, with amlitelimab demonstrating a mean percentage change of 69.9% to 80.1% in EASI scores at week 16, indicating their potential as effective disease-modifying therapies for moderate-to-severe atopic dermatitis.
OX40-OX40L Inhibition for the Treatment of Atopic Dermatitis-Focus on Rocatinlimab and Amlitelimab.Lé, AM., Torres, T.[2023]
In a phase 2a study involving 113 adults with moderate to severe atopic dermatitis, tezepelumab showed a numerically greater efficacy compared to placebo, with 64.7% of patients achieving a ≥50% reduction in eczema severity (EASI50) at week 12.
The safety profile of tezepelumab was comparable to placebo, with similar rates of treatment-emergent adverse events, suggesting it is a safe option for patients when combined with topical corticosteroids.
Tezepelumab, an anti-thymic stromal lymphopoietin monoclonal antibody, in the treatment of moderate to severe atopic dermatitis: A randomized phase 2a clinical trial.Simpson, EL., Parnes, JR., She, D., et al.[2022]

References

An anti-OX40 antibody to treat moderate-to-severe atopic dermatitis: a multicentre, double-blind, placebo-controlled phase 2b study. [2023]
OX40-OX40L Inhibition for the Treatment of Atopic Dermatitis-Focus on Rocatinlimab and Amlitelimab. [2023]
Tezepelumab, an anti-thymic stromal lymphopoietin monoclonal antibody, in the treatment of moderate to severe atopic dermatitis: A randomized phase 2a clinical trial. [2022]
Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. [2020]
Integrated Safety Analysis of Abrocitinib for the Treatment of Moderate-to-Severe Atopic Dermatitis From the Phase II and Phase III Clinical Trial Program. [2022]
Characterizing real world safety profile of oral Janus kinase inhibitors among adult atopic dermatitis patients: evidence transporting from the rheumatoid arthritis population. [2022]
Infectious adverse events in patients with atopic dermatitis treated with baricitinib. [2023]
TREatment of ATopic eczema (TREAT) Registry Taskforce: protocol for a European safety study of dupilumab and other systemic therapies in patients with atopic eczema. [2021]
Ruxolitinib Cream 1.5%: A Review in Mild to Moderate Atopic Dermatitis. [2023]
Tralokinumab Plus Topical Corticosteroids as Needed Provides Progressive and Sustained Efficacy in Adults with Moderate-to-Severe Atopic Dermatitis Over a 32-Week Period: An ECZTRA 3 Post Hoc Analysis. [2023]