Rocatinlimab for Eczema

(ROCKET-Orbit Trial)

No longer recruiting at 111 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: Biologics, Corticosteroids, Immunosuppressants, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 13

Duration: 52 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 teens with moderate-to-severe eczema, a skin condition that causes itchy and inflamed patches. The main goal is to determine the treatment's safety and tolerability. Teens aged 12 to 17 who have had eczema for over a year and haven't responded well to creams or ointments might be suitable for this trial. Participants will receive rocatinlimab through an injection every four weeks for about a year. As a Phase 3 trial, this study is the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

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.

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

Research shows that rocatinlimab is being tested for safety and effectiveness in treating moderate-to-severe eczema. Large studies involving both adults and teenagers aim to gather crucial safety information. Although long-term safety data is not yet available, ongoing research seeks to address this concern.

Earlier research found that rocatinlimab was generally well-tolerated. While specific side effects have not been detailed in the available information, its late-stage study status suggests earlier tests deemed it safe enough for larger group testing. Ongoing trials will offer more details on potential side effects and their frequency. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for eczema?

Most treatments for eczema, like topical corticosteroids and calcineurin inhibitors, focus on reducing inflammation and managing symptoms. But rocatinlimab works differently, targeting a specific immune pathway called OX40. This unique approach aims to alter the immune system's response, potentially offering longer-lasting relief with fewer flare-ups. Additionally, rocatinlimab is administered via subcutaneous injection every four weeks, which could be more convenient for patients compared to daily topical applications. Researchers are excited about rocatinlimab because it represents a novel way to manage eczema, potentially improving outcomes for patients who haven’t found success with existing treatments.

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

Research has shown that rocatinlimab, which participants in this trial will receive, may help treat moderate-to-severe eczema, also known as atopic dermatitis. In earlier studies, patients using rocatinlimab experienced a noticeable improvement in their eczema symptoms compared to those who received a placebo. Specifically, when combined with skin creams, rocatinlimab reduced the severity of the condition. It targets a part of the immune system involved in eczema. Early results suggest it can be effective for both adults and teenagers dealing with this challenging skin condition. ^{1 2 3 6 7}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

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.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Rocatinlimab

Trial Overview The 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.

How Is the Trial Designed?

Group I: Rocatinlimab Experimental Treatment 1 Intervention

Rocatinlimab will be administered subcutaneously every 4 weeks (Q4W) for 52 weeks with one additional 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

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]

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 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]

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]

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]

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]

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 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]

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]

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. 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- ...

5. ajmc.com ajmc.com/view/rocatinlimab-ad-combo-therapy-safe-effective-over-24-weeks

Rocatinlimab AD Combo Therapy Safe, Effective Over 24 ... Rocatinlimab with concomitant topical therapy significantly improved clinical signs and symptoms of atopic dermatitis in adults: results from ...

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

Kyowa Kirin Announces Top-line Data from Rocatinlimab ... ROCKET HORIZON is a Phase 3, randomized, placebo-controlled, double-blind trial assessing the efficacy, safety and tolerability of rocatinlimab ...

7. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(23)01618-5/fulltext

Efficacy of rocatinlimab for moderate-to-severe atopic ... The authors also raised concerns over an absence of long-term safety data. Although not available in the main text of the Article, we provided ...