AMG 691 for Asthma

Recruiting at 2 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Amgen

Must be taking: Low-dose ICS

Disqualifiers: Malignancy, Anaphylaxis, Immunodeficiency, TB, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

124 Participants Needed

Trial Summary

What is the purpose of this trial?

The main objective of this study is to assess the safety and tolerability of AMG 691 as single doses (healthy participants only) and multiple doses in healthy participants and participants with mild-to-moderate asthma.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you use inhaled corticosteroids (ICS), you must be on a stable low or medium dose for at least 12 weeks before the trial.

What data supports the effectiveness of the drug AMG 691 for asthma?

The research on omalizumab, a similar anti-IgE therapy, shows it can improve asthma control and reduce symptoms in patients with severe asthma. This suggests that AMG 691, if it works similarly, might also be effective for asthma. ^{1 2 3 4 5}

Research Team

MD

Principal Investigator

Amgen

Eligibility Criteria

This trial is for healthy adults and those with mild-to-moderate asthma, aged 18-65. Women must not be able to bear children. Asthma patients need a specific lung function score and blood eosinophil count, plus documented responsiveness to bronchodilators.

Inclusion Criteria

I am eligible for both parts A and B of the study.

I understand the study and have signed the consent form.

I am between 18 and 65 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD)

Healthy participants receive single ascending doses of AMG 691 or placebo

4 weeks

Multiple Ascending Dose (MAD)

Healthy participants receive multiple ascending doses of AMG 691 or placebo

8 weeks

Multiple Dose

Participants with mild-to-moderate asthma receive multiple doses of AMG 691 or placebo

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• AMG 691

Trial Overview The study tests AMG 691's safety in single (healthy participants) and multiple doses (both groups). Participants are randomly assigned to receive either the real drug or a placebo without knowing which one they're getting.

Participant Groups

Group I: Part C: Multiple Dose Experimental Treatment 2 Interventions

Participants with mild-to-moderate asthma will be randomized in a 2:1 ratio to receive either AMG 691 or placebo.

Group II: Part B: Multiple Ascending Dose (MAD) Experimental Treatment 2 Interventions

Healthy participants will be randomized in a 3:1 ratio to receive either AMG 691 or placebo.

Group III: Part A: Single Ascending Dose (SAD) Experimental Treatment 2 Interventions

Healthy participants will be randomized in a 3:1 ratio to receive either AMG 691 or placebo.

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

Omalizumab treatment significantly improved clinical outcomes in non-atopic asthmatics, as shown by increases in the Global Evaluation of Treatment Effectiveness (GETE) and Asthma Control Test (ACT) scores over two years.

The effectiveness of omalizumab in non-atopic asthma was comparable to its effects in allergic asthmatics, indicating that anti-IgE therapy can be a viable treatment option for severe non-atopic asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of omalizumab in non-atopic asthma: results from a Spanish multicenter registry. de Llano, LP., Vennera, Mdel C., Álvarez, FJ., et al.[2015]

In a retrospective review of 167 patients treated with omalizumab for moderate-to-severe allergic asthma, significant improvements were observed in asthma control over time, with fewer symptoms and reduced need for rescue medication (p < 0.001).

The study found a 49% decrease in asthma exacerbations requiring urgent care within the first 12 months of treatment (p ≤ 0.01), supporting the long-term efficacy of omalizumab in managing difficult-to-treat asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omalizumab and asthma control in patients with moderate-to-severe allergic asthma: a 6-year pragmatic data review. Storms, W., Bowdish, MS., Farrar, JR.[2016]

In a 2-year study involving 943 patients with uncontrolled persistent allergic asthma, treatment with omalizumab significantly reduced asthma-related healthcare visits from an average of 6.2 visits per patient in the year before treatment to just 0.5 visits by the end of the second year.

Patients also experienced fewer missed work or school days due to asthma, dropping from an average of 26.4 days in the pre-treatment period to just 1.0 day at 24 months, indicating improved quality of life and disease control with omalizumab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthcare Resource Utilization in Patients Receiving Omalizumab for Allergic Asthma in a Real-World Setting. Braunstahl, GJ., Canvin, J., Peachey, G., et al.[2022]

Asthma affects around 300 million people globally, with severe asthma impacting about 20% of these patients, leading to a high risk of exacerbations and a significantly impaired quality of life.

The anti-IgE monoclonal antibody omalizumab has been shown to effectively reduce asthma exacerbations, improve lung function, and enhance quality of life in patients with severe persistent asthma who are inadequately controlled despite high-dose inhaled corticosteroids and long-acting beta(2)-agonists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uncontrolled asthma: a review of the prevalence, disease burden and options for treatment. Peters, SP., Ferguson, G., Deniz, Y., et al.[2022]

A study reviewing 770 patient charts in Germany and Italy found that while only 4 patients were receiving omalizumab, an additional 31 patients met the eligibility criteria for the therapy, suggesting a significant underutilization of this effective treatment for uncontrolled severe allergic asthma.

Extrapolating the data indicates that over 6500 patients in Germany and more than 3200 in Italy could potentially benefit from omalizumab therapy, highlighting the need for better referral practices and evaluation of asthma patients by primary care physicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eligibility for treatment with omalizumab in Italy and Germany. Buhl, R., Marco, AG., Cohen, D., et al.[2015]

References

1. England pubmed.ncbi.nlm.nih.gov

Effects of omalizumab in non-atopic asthma: results from a Spanish multicenter registry. [2015]

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

Omalizumab and asthma control in patients with moderate-to-severe allergic asthma: a 6-year pragmatic data review. [2016]

3. England pubmed.ncbi.nlm.nih.gov

Healthcare Resource Utilization in Patients Receiving Omalizumab for Allergic Asthma in a Real-World Setting. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Uncontrolled asthma: a review of the prevalence, disease burden and options for treatment. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Eligibility for treatment with omalizumab in Italy and Germany. [2015]