AMG 691 for Asthma
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Amgen
Must be taking: Low-dose ICS
Disqualifiers: Malignancy, Anaphylaxis, Immunodeficiency, TB, others
No Placebo Group
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?
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.
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Trial 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 (Monoclonal Antibodies)
Trial OverviewThe 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
3Treatment groups
Experimental Treatment
Group I: Part C: Multiple DoseExperimental Treatment2 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 Treatment2 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 Treatment2 Interventions
Healthy participants will be randomized in a 3:1 ratio to receive either AMG 691 or placebo.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Orange County Research CenterLake Forest, CA
Translational Clinical Research LLCAventura, FL
Prism Research LLC dba Nucleus NetworkSaint Paul, MN
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Who Is Running the Clinical Trial?
AmgenLead Sponsor
References
Effects of omalizumab in non-atopic asthma: results from a Spanish multicenter registry. [2015]Aim. To evaluate the effectiveness of omalizumab in non-atopic asthma. Methods. Using data from a multicenter registry of severe asthma, we evaluated and compared the clinical outcome of 29 omalizumab-treated severe non-atopic asthmatics with 266 omalizumab-treated severe allergic asthmatics. Effectiveness was assessed by considering severe exacerbations, pulmonary function, the Global Evaluation of Treatment Effectiveness (GETE) scale, and Asthma Control Test (ACT). Results. Omalizumab demonstrated significant improvement in the clinical status of non-atopic asthmatics as measured by GETE, which rose from 1.6 ± 1.1 to 2.8 ± 0.9 [corrected] at 4 months (p = .0215) to 2.9 ± 0.9 at 1 year (p = .0093) and to 3.4 ± 0.6 at 2 years (p = .0078), and by the ACT, which increased from 13.3 ± 5.5 [corrected] to 17.5 ± 5.4 at 4 months (p = .0236) to 17.9 ± 4.8 at 1 year (p = .0136) and to 20.6 ± 3.9 at 2 years (p = .0024). Forced expiratory volume in 1 second (FEV1) improved from 61.0 ± 19.4% to 65.1 ± 17.2 at 4 months to 64.1 ± 24.7 at 1 year and to 67.3 ± 23.0% [corrected] at 2 years, but without significant differences between initial and follow-up measurements (p = .52, .91, and .45, respectively) and exacerbations decreased from 3.1 ± 3.5 to 1.9 ± 2.8 at 1 year (p = .1709) to 1.8 ± 4.4 at 2 years (p = .2344). The results were not significantly different from those obtained in atopic asthmatics. Conclusion. Anti-IgE therapy can be effective in non-atopic severe asthma.
Omalizumab and asthma control in patients with moderate-to-severe allergic asthma: a 6-year pragmatic data review. [2016]Controlled clinical trials have shown the recombinant humanized monoclonal anti-IgE antibody omalizumab to improve asthma control and reduce symptom exacerbations in patients with moderate-to-severe allergic asthma who remain clinically unstable despite optimal medical therapy. An objective retrospective review compared clinical experience with the data reported in the controlled studies. Data tracking for 167 patients progressively enrolled between 2003 and 2010 treated with omalizumab included symptoms, forced expiratory volume at 1 second (FEV(1)), systemic steroid bursts, and need for short-acting bronchodilator rescue measured at the start of therapy; 3, 6, and 12 months after starting treatment, and yearly thereafter. Exacerbations were compared for the 12 months before and the 12 months after starting treatment in a subgroup of patients. Asthma control improved with omalizumab over time (up to 6 years) as indicated by fewer symptoms and less need for rescue medication (p
Healthcare Resource Utilization in Patients Receiving Omalizumab for Allergic Asthma in a Real-World Setting. [2022]Inadequately controlled asthma is associated with increased healthcare resource utilization. The eXpeRience registry was initiated to evaluate real-world outcomes in patients receiving omalizumab for uncontrolled persistent allergic asthma. The current analysis of data from the eXpeRience registry focuses on healthcare resource utilization and on absences from work or school.
Uncontrolled asthma: a review of the prevalence, disease burden and options for treatment. [2022]An estimated 300 million people are affected by asthma worldwide and the burden is likely to rise substantially in the next few decades. Estimates of the prevalence of asthma range from 7% in France and Germany to 11% in the USA and 15-18% in the United Kingdom. Approximately 20% of these patients have severe asthma, of which 20% is inadequately controlled. Patients with inadequately controlled severe persistent asthma are at a particularly high risk of exacerbations, hospitalization and death, and often have severely impaired quality of life. Current management of asthma focuses on a stepwise approach tailored to disease severity. In addition to needing high-dose inhaled corticosteroids (ICS) and long-acting beta(2)-agonists (LABAs), patients with severe persistent asthma often require additional controller medications, such as anti-leukotrienes, oral LABAs, oral corticosteroids and/or anti-IgE therapy. There is currently little evidence on which to base treatment decisions in patients with inadequately controlled severe persistent asthma already treated with ICS and LABAs. The anti-IgE monoclonal antibody omalizumab is the most recent addition to the list of treatment options for these patients and has been shown to reduce exacerbations and emergency visits and improve lung function, symptom scores and quality of life in patients with difficult-to-treat asthma whose symptoms remain inadequately controlled despite receiving ICS and LABAs. Comparative trials are needed to determine the merits of different treatments and strategies for patients with inadequately controlled severe persistent asthma and to identify patients likely to benefit from new treatment options.
Eligibility for treatment with omalizumab in Italy and Germany. [2015]Omalizumab is an add-on therapy for patients with uncontrolled severe allergic asthma. In Europe, patients must fulfil a number of additional criteria to become eligible for omalizumab therapy, creating a challenge for epidemiology studies to quantify the potential patient pool. Thus, and in the absence of robust data, the number of omalizumab-eligible patients has remained unclear. To assess eligible patient numbers, a chart-audit design approach was employed to measure epidemiology variables based on patient-level data. 770 patient charts were reviewed in designated towns in Germany and Italy, in collaboration with >200 primary care physicians (PCPs) and respiratory specialists (RS). This study sample represents >50% and >70% of local RS in these designated towns of Germany and Italy, respectively. Of patient charts evaluated, 4 patients were currently receiving omalizumab. A further 31 patients (12 PCP; 19 RS) were evaluated as omalizumab-eligible (i.e. fulfilled all product label criteria) but were not receiving the drug. Extrapolating to a national level, this yields >6500 eligible patients in Germany, and >3200 in Italy. Furthermore, this study sample revealed a significant number of PCPs treating uncontrolled severe asthma patients without referral to RS; these patients are not consistently evaluated for FEV1, aero-allergen sensitivity, a qualitative understanding of severe exacerbations, and day and night-time symptoms. This study suggests that significant numbers of omalizumab-naïve severe allergic asthma patients in Germany/Italy are eligible for omalizumab therapy. Despite proven benefits in uncontrolled severe allergic asthma, adjunctive omalizumab therapy is underutilized.