726 Participants Needed

Rocatinlimab for Eczema

(ROCKET-Horizon Trial)

Recruiting at 219 trial locations
AC
Overseen ByAmgen Call Center
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 is testing a new medication called rocatinlimab to help people with eczema. The goal is to see if it can reduce the redness, itching, and swelling better than other treatments. The study focuses on patients whose eczema is severe and not well-controlled by other treatments.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications before joining the trial. Specifically, you must stop systemic corticosteroids, systemic immunosuppressants, phototherapy, and Janus kinase inhibitors at least 4 weeks before starting. You also need to stop using topical treatments like corticosteroids and immunosuppressants 1 week before starting.

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. Participants who received 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 and found it to be generally safe for human use in this context.45678

What makes the drug Rocatinlimab unique for treating eczema?

Rocatinlimab is unique because it targets the OX40 pathway, which is important for T-cell responses involved in eczema, unlike other treatments that target different pathways or are applied topically.125910

Research Team

M

MD

Principal Investigator

Amgen

Eligibility Criteria

This trial is for adults with moderate-to-severe atopic dermatitis (AD) who haven't responded well to medium or stronger topical corticosteroids, or when such treatments are not advised. Participants must have a significant itch, extensive rash covering at least 10% of their body, and meet specific severity scores on AD scales.

Inclusion Criteria

vIGA-AD score ≥3
I often feel itchy, rating my itchiness at least a 4 out of 10.
At least 10% of my skin is affected by my condition.
See 3 more

Exclusion Criteria

I haven't used any strong skin medications or treatments in the last week.
I haven't taken steroids, immunosuppressants, had phototherapy, or used Janus kinase inhibitors recently.
I haven't taken any biological medication for the last 12 weeks or 5 half-lives, whichever is longer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Rocatinlimab or placebo every 4 weeks for 24 weeks with a loading dose at Week 2

24 weeks
6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Rocatinlimab
Trial OverviewThe study tests Rocatinlimab's effectiveness against a placebo in improving AD symptoms by week 24. It uses two measures: the vIGA-AD scale assessing overall disease severity and the EASI score evaluating rash area and intensity.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RocatinlimabExperimental Treatment1 Intervention
Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.
Group II: PlaceboPlacebo Group1 Intervention
Placebo Q4W for 24 weeks with a loading 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

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]
In a 24-week study involving 226 adults with moderate-to-severe atopic dermatitis, nemolizumab (30 mg) significantly improved skin inflammation and itching compared to placebo, showing effects as early as week 4.
The treatment was found to be safe and well-tolerated, with common side effects including nasopharyngitis and upper respiratory infections, indicating a favorable safety profile for patients.
Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus.Silverberg, JI., Pinter, A., Pulka, G., et al.[2020]

References

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]
An anti-OX40 antibody to treat moderate-to-severe atopic dermatitis: a multicentre, double-blind, placebo-controlled phase 2b study. [2023]
Infectious adverse events in patients with atopic dermatitis treated with baricitinib. [2023]
Characterizing real world safety profile of oral Janus kinase inhibitors among adult atopic dermatitis patients: evidence transporting from the rheumatoid arthritis population. [2022]
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]