AMG 691 for Asthma

Recruiting at 16 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and tolerability of AMG 691, a potential new treatment for asthma. It includes both healthy participants and those with mild-to-moderate asthma to evaluate the drug's performance in different groups. Healthy participants receive single or multiple doses, while those with asthma receive multiple doses. Participants with asthma should have had the condition for over a year and experience moderate symptoms. This study aims to understand how well AMG 691 is tolerated and its potential to improve asthma management. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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.

Is there any evidence suggesting that AMG 691 is likely to be safe for humans?

Research has shown that AMG 691 is currently being tested for safety in humans. This trial is in the first phase, focusing on the safety and tolerability of the treatment for both healthy individuals and those with mild-to-moderate asthma. Early-phase trials like this typically have limited safety information but are designed to closely monitor any side effects. Although extensive safety data is not yet available, participants receive careful monitoring to ensure their well-being. ^{1 2 3 4 5}

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

Researchers are excited about AMG 691 for asthma because it offers a potentially novel approach to treating the condition. Unlike standard treatments, which often include inhaled corticosteroids or bronchodilators targeting airway inflammation and constriction, AMG 691 may work through a different mechanism, potentially offering benefits to those who don't respond well to existing therapies. This new treatment could provide an alternative for asthma patients, particularly those with mild to moderate forms, by addressing the underlying causes of their symptoms in a unique way. If successful, AMG 691 could expand the arsenal of asthma treatments and improve quality of life for many individuals.

What evidence suggests that AMG 691 might be an effective treatment for asthma?

Research shows that AMG 691, which participants in this trial may receive, might help reduce asthma symptoms. One study showed a 49% drop in asthma attacks requiring urgent care during the first year of treatment, which is promising. This suggests the drug could help manage asthma symptoms and lessen the severity of flare-ups. While these results are encouraging, further research is needed to confirm the long-term benefits of AMG 691 for people with asthma. ^{1 2 5 6 7}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

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 understand the study and have signed the consent form.

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

I am generally healthy according to my doctor's evaluation.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06637371

Study Details | NCT06637371 | A Phase 1, Randomized, ... 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 ...

2. withpower.com withpower.com/trial/phase-1-asthma-9-2024-942b0

AMG 691 for Asthma · Recruiting Participants for Phase ... 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 ...

3. tipranks.com tipranks.com/news/company-announcements/amgens-amg-691-a-promising-step-in-asthma-treatment

Amgen's AMG 691: A Promising Step in Asthma Treatment? This drug is being evaluated for its safety and effectiveness in treating asthma symptoms, with a placebo used as a control. The study is ...

4. clinconnect.io clinconnect.io/trials/NCT06637371

A Phase 1, Randomized, Double-blind, Placebo-controlled This clinical trial is testing a new medication called AMG 691 to see how safe it is for people, including those with mild-to-moderate asthma. The study ...

5. app.trialscreen.org app.trialscreen.org/trials/phase-1-randomized-double-blind-placebo-controlled-evaluating-amg-691-trial-nct06637371

A Phase 1, Randomized, Double-blind, Placebo-controlled ... Back to study results. A Phase 1 study of AMG 691 in healthy and asthmatic participants. Evaluating the safety and tolerability of an investigational drug, ...

6. trial.medpath.com trial.medpath.com/clinical-trial/7667adbf8a89933e/2025-520503-27-00-safety-tolerability-pharmacokinetics-amg-691-asthma

A Phase 1, Randomized, Double-blind, Placebo-controlled ... 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 ...

7. synapse.patsnap.com synapse.patsnap.com/drug/e6552efc68304ccf800927937a7686db

AMG-691 - Drug Targets, Indications, Patents A Phase 1, Randomized, Double-blind, Placebo-controlled, Integrated Single Ascending Dose, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, ...