Rocatinlimab for Asthma

Recruiting at 148 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Amgen

Must be taking: Inhaled corticosteroids

Must not be taking: Systemic antibiotics, Antivirals

Disqualifiers: Pulmonary disease, Smoking, COVID-19, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to describe the efficacy of rocatinlimab in reducing asthma exacerbations.

Will I have to stop taking my current medications?

The trial does not specify that you need to stop your current asthma medications. In fact, it requires that you continue your existing therapy with medium to high doses of inhaled corticosteroids and at least one additional controller medication.

How is the drug Rocatinlimab different from other asthma treatments?

Rocatinlimab is a novel monoclonal antibody treatment that targets specific pathways involved in asthma inflammation, potentially offering a new option for patients who do not respond well to standard treatments like bronchodilators and inhaled steroids. Unlike existing treatments that target IgE or IL-5, Rocatinlimab may work on different inflammatory pathways, providing a unique approach for managing severe asthma. ^{1 2 3 4 5}

Research Team

MD

Principal Investigator

Amgen

Eligibility Criteria

This trial is for adults aged 18-75 with moderate-to-severe asthma, diagnosed over a year ago. They must have had at least one asthma attack in the past year despite using medium to high doses of inhalers and other controllers. Their lung function and symptom scores will be checked to see if they fit.

Inclusion Criteria

I am between 18 and 75 years old.

I have been diagnosed with asthma by a doctor for at least a year.

My asthma control score is 1.5 or higher.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive rocatinlimab or placebo by SC injection during the blinded treatment period

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Rocatinlimab (Monoclonal Antibodies)

Trial Overview The study tests Rocatinlimab's ability to reduce asthma attacks compared to a placebo. Participants are randomly assigned either the drug or placebo alongside their usual asthma treatments, to see which works better.

Participant Groups

Group I: Treatment Arm D: Dose 3 Rocatinlimab Experimental Treatment 1 Intervention

Participants will receive dose 3 rocatinlimab by SC injection during the blinded treatment period.

Group II: Treatment Arm C: Dose 2 Rocatinlimab Experimental Treatment 1 Intervention

Participants will receive dose 2 rocatinlimab by SC injection during the blinded treatment period.

Group III: Treatment Arm B: Dose 1 Rocatinlimab Experimental Treatment 1 Intervention

Participants will receive dose 1 rocatinlimab by SC injection during the blinded treatment period.

Group IV: Treatment Arm A: Placebo Placebo Group 1 Intervention

Participants will receive placebo by subcutaneous (SC) injection during the blinded treatment period.

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 study of 1,278 Medicare patients with severe eosinophilic asthma, initiating treatment with mepolizumab led to a significant 27% reduction in asthma exacerbations over a 12-month follow-up period.

Mepolizumab also resulted in a 16% decrease in the use of oral corticosteroids and a notable reduction in asthma-related healthcare costs, averaging $888 less per patient, highlighting its efficacy and economic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Mepolizumab on Exacerbations in the US Medicare Population. Sethi, S., Bogart, M., Corbridge, T., et al.[2023]

Dupilumab significantly reduced the occurrence of asthma exacerbations by 87% in patients with moderate-to-severe asthma compared to placebo, with only 6% of patients experiencing exacerbations on dupilumab versus 44% on placebo.

The treatment also led to improvements in lung function and reduced levels of Th2-associated inflammatory markers, although it was associated with more frequent side effects like injection-site reactions and nasopharyngitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab in persistent asthma with elevated eosinophil levels. Wenzel, S., Ford, L., Pearlman, D., et al.[2022]

Several monoclonal antibodies, such as omalizumab and dupilumab, effectively target specific molecules involved in type-2 inflammation in asthma, providing tailored treatment options for patients with severe asthma.

Current and future biological therapies are being developed to target various cytokines and receptors, allowing for personalized treatment strategies based on the specific asthma phenotype or endotype, which can lead to better management of difficult-to-treat asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biologics in severe asthma. Pelaia, C., Pelaia, G., Crimi, C., et al.[2022]

Omalizumab is currently the only approved biological treatment for severe IgE-dependent asthma, demonstrating safety and effectiveness for patients who do not respond to standard therapies.

Investigational monoclonal antibodies targeting specific inflammatory pathways, such as mepolizumab for IL-5 and others for IL-4 and IL-13, show promise in improving lung function and quality of life in patients with severe asthma, but further studies with larger populations are necessary to confirm their efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monoclonal Antibodies for the Management of Severe Asthma. Rubinsztajn, R., Chazan, R.[2022]

Omalizumab, an anti-immunoglobulin E monoclonal antibody, has been shown to be effective and safe for treating severe persistent asthma, as supported by multiple studies since its FDA approval.

Recent research has identified predictive markers that can help determine which patients with severe asthma are most likely to benefit from omalizumab therapy, enhancing confidence in its use for therapeutic trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of asthma with anti-immunoglobulin E monoclonal antibody. Liu, AH.[2016]

References

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

Impact of Mepolizumab on Exacerbations in the US Medicare Population. [2023]

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

Dupilumab in persistent asthma with elevated eosinophil levels. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

Biologics in severe asthma. [2022]

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

Monoclonal Antibodies for the Management of Severe Asthma. [2022]

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

Treatment of asthma with anti-immunoglobulin E monoclonal antibody. [2016]