Status:
COMPLETED
A Study to Evaluate the Safety and Efficacy of AVTX-002 for the Treatment of Poorly Controlled Non-Eosinophilic Asthma.
Lead Sponsor:
Avalo Therapeutics, Inc.
Conditions:
Non-Eosinophilic Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to evaluate the efficacy of AVTX-002 compared with placebo in patients with poorly controlled non-eosinophilic asthma (NEA).
Eligibility Criteria
Inclusion
- Documented non-eosinophilic asthma diagnosis (\<300 eosinophils/μL).
- Symptoms consistent with a diagnosis of asthma that is poorly controlled as determined by an ACQ score ≥ 1.5.
- Poorly controlled asthma despite the use of a Long-Acting Beta-Agonists and Inhaled Corticosteroid for at least 3 consecutive months immediately prior to screening.
- Subjects must have had at least one asthma exacerbation in the last 24 months.
Exclusion
- Pulmonary disease other than asthma.
- Currently on biologic therapy. Previous biologic therapy is permitted with adequate washout (12 weeks or 5 half-lives, whichever is longer).
- Use of systemic immunosuppressants within the last 6 months.
- Use of systemic corticosteroids within 6 weeks prior to Screening or use of antibiotics within 4 weeks prior to Screening.
- Subject has alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) \>5 upper limit of normal (ULN) and/or serum creatinine concentration \>1.5 mg/dL.
- Subject has hemoglobin ≤10 g/dL, neutrophils ≤1,500/μl, and/or platelets ≤75,000/μl.
Key Trial Info
Start Date :
February 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2023
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT05288504
Start Date
February 24 2022
End Date
May 11 2023
Last Update
September 5 2024
Active Locations (24)
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1
Tucson Neuroscience Research - M3, Wake Research
Tucson, Arizona, United States, 85710
2
Center For Clinical Trials of Sacramento
Sacramento, California, United States, 95823
3
Allergy and Asthma Medical Group of the Bay Area
Walnut Creek, California, United States, 94598
4
Center For Clinical Trials of San Gabriel
West Covina, California, United States, 91790-3402