A Study to Evaluate the Safety and Efficacy of AVTX-002 for the Treatment of Poorly Controlled Non-Eosinophilic Asthma.
NCT ID: NCT05288504
Last Updated: 2024-09-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
91 participants
INTERVENTIONAL
2022-02-24
2023-05-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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AVTX-002
Approximately 40 subjects will receive AVTX-002 at a dose of 600 mg three times during the study.
AVTX-002
Dose of 600 mg administered subcutaneously three times during the study.
Placebo
Approximately 40 subjects will receive placebo sourced as normal saline three times during the study.
Placebo
Placebo sourced as normal saline administered subcutaneously three times during the study.
Interventions
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AVTX-002
Dose of 600 mg administered subcutaneously three times during the study.
Placebo
Placebo sourced as normal saline administered subcutaneously three times during the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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Avalo Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Garry Neil, MD
Role: STUDY_DIRECTOR
Avalo Therapeutics, Inc.
Locations
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Tucson Neuroscience Research - M3, Wake Research
Tucson, Arizona, United States
Center For Clinical Trials of Sacramento
Sacramento, California, United States
Allergy and Asthma Medical Group of the Bay Area
Walnut Creek, California, United States
Center For Clinical Trials of San Gabriel
West Covina, California, United States
IMMUNOe Research Centers
Centennial, Colorado, United States
National Jewish Health
Denver, Colorado, United States
Helix Biomedics, LLC
Boynton Beach, Florida, United States
Suncoast Research Group LLC
Miami, Florida, United States
Suncoast Research Associates LLC
Miami, Florida, United States
Pro-Care Research Center, Corp.
Miami Gardens, Florida, United States
Innovation Medical Research Center
Palmetto Bay, Florida, United States
ASHA Clinical Research-Munster, LLC
Hammond, Indiana, United States
Family Allergy and Asthma Research Institute
Louisville, Kentucky, United States
Continental Clinical Solutions, LLC
Towson, Maryland, United States
Pulmonary Research Institute of Southeast Michigan
Farmington Hills, Michigan, United States
Midwest Clinical Research
St Louis, Missouri, United States
Meridian Clinical Research
Lincoln, Nebraska, United States
OK Clinical Research
Edmond, Oklahoma, United States
Affinity Health
Nashville, Tennessee, United States
Amarillo Center For Clinical Research
Amarillo, Texas, United States
South Texas Medical Research Institute, Inc
Boerne, Texas, United States
Pioneer Research Solutions
Houston, Texas, United States
Meridian Clinical Research
Portsmouth, Virginia, United States
Clinical Research Partners, LLC
Richmond, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AVTX-002-NEA-201
Identifier Type: -
Identifier Source: org_study_id
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