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

• Status: Recruiting
• Trial end date: 2022-09-19
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cerecor Inc

Criteria

Inclusion Criteria:

• Documented non-eosinophilic asthma diagnosis (<300 eosinophils/μL).

• Symptoms consistent with a diagnosis of asthma that is poorly controlled with an inhaled corticosteroid (ICS) as determined by an ACQ score ≥ 1.5.

• Poorly controlled asthma despite the use of a Long-Acting Beta-Agonists for at least 3 months.

• Subjects must have had at least one asthma exacerbation in the last 12 months.

Exclusion Criteria:

• 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.