Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics

Launched by ASTRAZENECA · May 14, 2019

Keywords

ClinConnect Summary

The Benralizumab Airway Remodeling Study is looking at how a medication called benralizumab can help people with severe asthma that is linked to high levels of a type of white blood cell known as eosinophils. This study is particularly focused on patients who still have asthma symptoms even when they are taking their usual medications, which include inhaled steroids and long-acting bronchodilators. Over a treatment period of 48 weeks, researchers will assess any changes in lung function and the structure of the airways in these patients. After the treatment ends, there will be an additional 4-week follow-up to see how participants are doing.

To be eligible for this trial, participants must be between 18 and 70 years old and have been diagnosed with asthma that requires ongoing treatment. They should have been on a high dose of inhaled steroids and a long-acting bronchodilator for at least three months before joining the study. Other requirements include having a specific level of lung function and a certain number of eosinophils in their blood. It's important to note that individuals with certain health conditions or who are currently pregnant or breastfeeding cannot participate. This study is currently recruiting participants, and anyone who joins can expect regular check-ups and support throughout the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female aged 18 through 70 years.
• • 2. Physician-diagnosed asthma requiring continuous treatment with medium- or high-dose ICS plus LABA with or without additional controller medication for at least 12 months prior to Visit 1, and current treatment with high-dose ICS plus LABA for at least 3 months prior to Visit 1 with or without additional asthma maintenance medication.
• • 3. Morning pre-BD FEV1 ≥50 to \<80% of predicted normal value (PNV) and ≥1 liter (L) or morning pre-BD FEV1 ≥ 50 to \< 90% of PNV, if historical pre-BD FEV1 value (within 12 months prior to screening visit) was \< 80% of PNV.
• • 4. A blood eosinophil count meeting any of 3 criteria: ≥300 cells/µL during screening or ≥ 220 to \< 300 cells/μL during screening and documented eosinophil count of ≥ 300 cells/μL in the past 12 months, or ≥150 to \<300 cells/µL during screening plus one of the following: presence of nasal polyps or pre-BD FVC \<65% predicted at Visit 2
• • 5. Negative pregnancy test.
• • 6. Asthma control questionnaire (ACQ-6) \>1.5.
• • 7. Fewer than 12 exacerbations within the 6 months prior to Visit 3.
• Exclusion Criteria:
• 1. Any disease or concomitant medication which could affect study results or safety of study participants, including:
• • current smokers
• • history of cancer
• • life-threatening asthma
• • clinically important pulmonary disease other than asthma
• • 2. Use of chronic immunosuppressive medication or receipt of immunoglobulin (or blood products) within 30 days prior to the date informed consent is obtained.
• 3. Previously received:
• • benralizumab
• • live attenuated vaccines 30 days prior to the date of randomization.
• • bronchial thermoplasty in the last 24 months prior to Visit 1
• • any investigational non-biologic within 30 days (or 5 half-lives) prior to the date informed consent is obtained, whichever is longer.
• • any marketed or investigational biologic for the treatment of asthma within 4 months (or 5 half-lives) prior to the date informed consent is obtained, whichever is longer.
• • 4. Currently pregnant, breastfeeding or lactating women.