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

Avalo Therapeutics

Status and phase: Completed; Phase 2

Conditions: Non-Eosinophilic Asthma

Treatments: Drug: Placebo; Drug: AVTX-002

Study type: Interventional

Funder types: Industry

Identifiers

NCT05288504

AVTX-002-NEA-201

Details and patient eligibility

About

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).

Enrollment: 91 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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91 participants in 2 patient groups, including a placebo group

AVTX-002

Experimental group

Description:

Approximately 40 subjects will receive AVTX-002 at a dose of 600 mg three times during the study.

Treatment:

Drug: AVTX-002

Placebo

Placebo Comparator group

Description:

Approximately 40 subjects will receive placebo sourced as normal saline three times during the study.

Treatment:

Drug: Placebo