Rocatinlimab for Eczema

(ROCKET-Ignite Trial)

No longer recruiting at 280 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Amgen

Must not be taking: Biologics, Corticosteroids, Immunosuppressants, others

Disqualifiers: Biological treatment, Phototherapy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called rocatinlimab for people with eczema, a condition that causes itchy, inflamed skin. The goal is to determine if rocatinlimab is safe and effective when used alone. Participants may receive one of two doses of rocatinlimab or a placebo, which contains no active drug. This trial suits adults who have had eczema for at least a year and have not found relief with strong topical steroids. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potential new treatment for eczema.

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.

Is there any evidence suggesting that rocatinlimab is likely to be safe for humans?

Research has shown that rocatinlimab, a treatment for eczema, is generally well-tolerated. In earlier studies, it appeared safe for people with moderate to severe eczema. Most reported side effects were mild to moderate, while serious side effects were rare and similar to those of other eczema treatments. These findings suggest that rocatinlimab is a safe option for many patients considering participation in a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Rocatinlimab for eczema because it targets the immune system in a novel way compared to standard treatments. While most eczema treatments, like topical corticosteroids or calcineurin inhibitors, focus on reducing inflammation locally, Rocatinlimab works by modulating the immune response more broadly, potentially offering longer-lasting relief. This treatment is administered by injection every four weeks, which might be more convenient for patients compared to daily topical treatments. Additionally, its unique mechanism could provide an option for those who haven't found success with current therapies.

What evidence suggests that rocatinlimab might be an effective treatment for eczema?

Research shows that rocatinlimab may effectively treat moderate to severe eczema, also known as atopic dermatitis. In this trial, participants will receive either rocatinlimab at different dosages or a placebo. Studies have found that rocatinlimab improves treatment outcomes and reduces the need for steroids. Some research has examined its ability to enhance skin condition using the Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD), a tool that measures eczema severity. These findings suggest that rocatinlimab could be a promising option for people with hard-to-treat eczema. Experts have noted its potential benefits in managing this skin condition in real-world settings. ^{1 2 5 6 7}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

Adults with moderate-to-severe atopic dermatitis (eczema) who haven't responded well to strong topical corticosteroids, or creams that suppress the immune system, may qualify. They should have a significant area of their body affected and experience intense itching. Those recently treated with biologics, systemic steroids, other immunosuppressants, phototherapy or certain inhibitors can't participate.

Inclusion Criteria

Your Eczema Area and Severity Index (EASI) score is 16 or higher.

Your EASI score is 16 or higher.

My skin condition didn't improve after using strong creams or ointments.

Exclusion Criteria

I haven't taken steroids, immunosuppressants, phototherapy, or JAK inhibitors recently.

Have you ever used topical steroid creams (i.e hydrocortisone)

I haven't used any strong skin medications or immune-suppressing creams in the last week.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive rocatinlimab or placebo with a loading dose at Week 2, followed by doses every 4 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Rocatinlimab

Trial Overview

The trial is testing Rocatinlimab's effectiveness and safety as a standalone treatment for eczema compared to a placebo. Participants will be randomly assigned to receive either Rocatinlimab or an inactive substance without knowing which one they are receiving.

How Is the Trial Designed?

Group I: Arm B Experimental Treatment 1 Intervention

Rocatinlimab Dose 2 Q4W + loading dose at Week 2

Group II: Arm A Experimental Treatment 1 Intervention

Rocatinlimab Dose 1 every 4 weeks (Q4W) + loading dose at Week 2

Group III: Arm C Placebo Group 1 Intervention

Placebo Q4W+ loading dose at Week 2

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

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

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

Published Research Related to This Trial

In a study involving 261,855 patients with atopic dermatitis (AD), the safety profile of Janus Kinase Inhibitors (JAK-Is) was assessed by comparing health outcomes to a rheumatoid arthritis (RA) cohort of 5,296 patients, revealing that the incidence rates of health outcomes in the AD cohort were 13-50% lower than in the RA cohort.

The findings suggest that while the absolute risks of health outcomes in the AD population are higher than in the general population, JAK-Is may still present a safer profile for AD patients compared to those with RA, indicating a need for further validation in similar populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing real world safety profile of oral Janus kinase inhibitors among adult atopic dermatitis patients: evidence transporting from the rheumatoid arthritis population. Montez-Rath, ME., Lubwama, R., Kapphahn, K., et al.[2022]

Abrocitinib, a JAK1-selective inhibitor, has been shown to have a manageable long-term safety profile for treating moderate-to-severe atopic dermatitis, based on an analysis of 2856 patients over 1614 patient-years.

While some dose-related adverse events like nausea and headache were observed, serious infections and other severe complications were relatively low, indicating that with proper patient selection, abrocitinib can be safely used for extended periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated Safety Analysis of Abrocitinib for the Treatment of Moderate-to-Severe Atopic Dermatitis From the Phase II and Phase III Clinical Trial Program. Simpson, EL., Silverberg, JI., Nosbaum, A., et al.[2022]

The TREAT Registry Taskforce is launching a long-term safety study to compare the safety of dupilumab with other systemic immunomodulating therapies in children and adults with moderate-to-severe atopic eczema, focusing on the incidence of malignancies and other serious adverse events.

This study will utilize a standardized approach across multiple national registries, providing valuable safety data that can inform regulatory bodies, clinicians, and pharmaceutical companies about the long-term risks associated with these therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TREatment of ATopic eczema (TREAT) Registry Taskforce: protocol for a European safety study of dupilumab and other systemic therapies in patients with atopic eczema. Bosma, AL., Spuls, PI., Garcia-Doval, I., et al.[2021]

Ruxolitinib cream 1.5% significantly improved disease severity, itching, and sleep disturbance in patients aged 12 and older with mild to moderate atopic dermatitis after 8 weeks of treatment, and continued to control symptoms for an additional 44 weeks when applied as needed.

The cream was well tolerated, with a safety profile similar to that of a placebo, and infrequent local side effects, making it a promising alternative to traditional treatments like corticosteroids for managing atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ruxolitinib Cream 1.5%: A Review in Mild to Moderate Atopic Dermatitis. Hoy, SM.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OX40-OX40L Inhibition for the Treatment of Atopic Dermatitis-Focus on Rocatinlimab and Amlitelimab. Lé, AM., Torres, T.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Baricitinib, a JAK1-2 inhibitor approved for moderate-to-severe atopic dermatitis, has a safety profile where infections are the most common side effects, primarily mild-to-moderate cases like upper respiratory infections and herpes simplex exacerbations.

The analysis included data from eight clinical trials, highlighting the need for more real-world data to better understand which patients may benefit most from baricitinib treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infectious adverse events in patients with atopic dermatitis treated with baricitinib. Antonelli, F., Malvaso, D., Caldarola, G., et al.[2023]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40012373/

a phase 3 program evaluating the efficacy and safety of ...

This is a large phase 3 program in AD that will provide important results on how well rocatinlimab works in adults and teenagers with moderate-to-severe AD.

2.

amgen.com

amgen.com/newsroom/press-releases/2025/09/amgen-and-kyowa-kirin-announce-top-line-results-from-rocatinlimab-phase-3-ascend-long-term-extension-study-in-adults-with-moderate-to-severe-atopic-dermatitis

Press Releases

AMGEN AND KYOWA KIRIN ANNOUNCE TOP-LINE RESULTS FROM ROCATINLIMAB PHASE 3 ASCEND LONG-TERM EXTENSION STUDY IN ADULTS WITH MODERATE TO SEVERE ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05651711

NCT05651711 | A Study Assessing Rocatinlimab (AMG ...

Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) ...

4.

ajmc.com

ajmc.com/view/combination-and-monotherapy-data-highlight-rocatinlimab-s-real-world-potential-in-ad-a-q-a-with-emma-guttman-yassky-md-phd

A Q&A With Emma Guttman-Yassky, MD, PhD

Rocatinlimab shows real-world promise for moderate to severe AD, enhancing treatment efficacy and reducing steroid reliance, explains Emma ...

5.

thelancet.com

thelancet.com/journals/lancet/article/PIIS0140-6736(22)02037-2/abstract

An anti-OX40 antibody to treat moderate-to-severe atopic ...

We evaluated the efficacy and safety of rocatinlimab in adults with moderate-to-severe atopic dermatitis. Methods. This multicentre, double-blind, placebo- ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05651711

NCT05651711 | A Study Assessing Rocatinlimab (AMG ...

A Phase 3, Randomized, 24-week, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety and Tolerability of Rocatinlimab (AMG 451) Monotherapy

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kyowakirin.com

kyowakirin.com/media_center/news_releases/2024/pdf/e20240925_01.pdf

Kyowa Kirin Announces Top-line Data from Rocatinlimab ...

The study also reached statistically significant differences from placebo for all key secondary endpoints, which include measurements of skin ...