Rocatinlimab for Eczema

(ROCKET-Orbit Trial)

Recruiting at 92 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

187 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 5 6 7 8}

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. ^{1 2 3 9 10}

Research Team

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.

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 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.

Participant Groups

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

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.

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]

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 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]

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]

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 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]

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]

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]

References

1. England 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. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

OX40-OX40L Inhibition for the Treatment of Atopic Dermatitis-Focus on Rocatinlimab and Amlitelimab. [2023]

3. United States 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. [2020]

5. New Zealand 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. [2022]

6. England 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Infectious adverse events in patients with atopic dermatitis treated with baricitinib. [2023]

8. England 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. [2021]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Ruxolitinib Cream 1.5%: A Review in Mild to Moderate Atopic Dermatitis. [2023]

10. New Zealand pubmed.ncbi.nlm.nih.gov

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]