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Evaluating benralizumab for severe eosinophilic asthma

A Phase 4, Multicenter, Randomized, Double-blind, Parallel Group, Placebo Controlled Study to Evaluate the Effect of Benralizumab on Structural and Lung Function Changes in Severe Eosinophilic Asthmatics

Phase 4 Interventional AstraZeneca · NCT03953300

This study is testing if benralizumab can improve lung function and reduce symptoms in people with severe eosinophilic asthma who aren't feeling better with their current treatments.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment81 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsbenralizumab
Locations53 sites (Birmingham, Alabama and 52 other locations)
Trial IDNCT03953300 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effects of benralizumab on lung function and structural changes in patients with severe eosinophilic asthma who have persistent symptoms despite standard treatment. Participants will receive either benralizumab or a placebo over a 48-week treatment period, followed by a 4-week follow-up. The study focuses on patients who have been on high-dose inhaled corticosteroids and long-acting beta-agonists for at least three months prior to enrollment. Changes in lung function and eosinophil levels will be monitored throughout the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with severe eosinophilic asthma requiring high-dose inhaled corticosteroids and long-acting beta-agonists.

Not a fit: Patients with asthma not requiring high-dose inhaled corticosteroids or those with other types of asthma may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve lung function and quality of life for patients with severe eosinophilic asthma.

How similar studies have performed: Other studies have shown promising results with similar biologic therapies for asthma, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Birmingham, Alabama and 52 other locations

+3 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions AsthmaEosinophilic AsthmaLung DiseasesInhaled CorticosteroidsICSLABAbenralizumabFasenra
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.