A Study to Evaluate the Safety and Efficacy of AVTX-002 for the Treatment of Poorly Controlled Non-Eosinophilic Asthma.

Completed · Phase 2 · Has a placebo group

Conditions studied: Non-Eosinophilic Asthma

In brief

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).

Key facts

Study ID

NCT05288504

Run by

Avalo Therapeutics, Inc.

People needed

91

Starts

2022-02-24

Expected to finish

2023-05-11

Last updated by the study team

2024-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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