Rocatinlimab for Asthma

Not currently recruiting at 197 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Amgen

Must be taking: Inhaled corticosteroids

Must not be taking: Systemic antibiotics, Antivirals

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, rocatinlimab, to determine if it reduces asthma attacks. Participants will receive varying doses of this treatment or a placebo to compare effects. Individuals with asthma for over a year who currently use inhaled steroids and other asthma medications might be suitable candidates. The goal is to discover if rocatinlimab manages asthma more effectively than existing treatments. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that rocatinlimab is generally safe for people. In a previous study on long-term safety, most participants handled the treatment well without serious side effects. Another study found that rocatinlimab significantly improved disease symptoms compared to a placebo. While some mild side effects were reported, the overall safety profile was positive. These findings suggest that rocatinlimab is safe for treating conditions like asthma and other diseases it has been tested for. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Most treatments for asthma, like inhaled corticosteroids and bronchodilators, focus on relieving symptoms or reducing inflammation. But rocatinlimab offers a fresh approach by targeting the immune system in a more precise way. Unlike traditional drugs, it involves a subcutaneous injection that could potentially provide longer-lasting control of asthma symptoms by modulating the body's immune response differently. Researchers are excited because this could mean fewer daily treatments and better management of asthma, possibly improving the quality of life for patients.

What evidence suggests that this trial's treatments could be effective for asthma?

Research shows that rocatinlimab may help treat asthma. In this trial, participants will receive different doses of rocatinlimab or a placebo. Previous studies found that people taking rocatinlimab experienced fewer asthma symptoms compared to those taking a placebo, which contains no active medicine. Specifically, patients had fewer asthma flare-ups, allowing better control of their condition. Researchers are studying rocatinlimab for its potential to reduce asthma attacks, which might help patients manage daily symptoms more easily. This treatment is also under investigation for other immune system conditions, like atopic dermatitis, suggesting it might offer broader benefits. ^{1 2 3 4 5}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

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

My asthma control score is 1.5 or higher.

I've been on a strong asthma treatment with steroids and another controller for over 3 months.

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 by SC injection during the blinded treatment period

12 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 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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06376045

Study Details | NCT06376045 | A Phase 2, Dose Ranging ... The primary objective of this study is to describe the efficacy of rocatinlimab in reducing asthma exacerbations.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11604902/

Results from a Double-Blind Placebo-Controlled Phase 2b ... Rocatinlimab has demonstrated significant and progressive improvement in multiple measures of clinical severity compared with placebo in adults ...

3. amgentrials.com amgentrials.com/study/?id=20220093

AMGEN - A Phase 2, Dose Ranging Study Assessing ... The primary objective of this study is to describe the efficacy of rocatinlimab in reducing asthma exacerbations.

4. 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 Rocatinlimab is also being studied for moderate to severe uncontrolled asthma, prurigo nodularis and potentially other conditions where T ...

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

Kyowa Kirin Announces Top-line Data from Rocatinlimab ... Key secondary endpoints assess the impact of rocatinlimab on itch, sleep, and quality of life as well as safety and tolerability. ROCKET is a ...