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

Study Overview
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Brief Summary
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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).

Official Title
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A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of AVTX-002 for the Treatment of Poorly Controlled Non-Eosinophilic Asthma

Conditions
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Non-Eosinophilic Asthma

Intervention / Treatment
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* Drug: AVTX-002
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AVTX-002<br>Approximately 40 subjects will receive AVTX-002 at a dose of 600 mg three times during the study. | Drug: AVTX-002<br>* Dose of 600 mg administered subcutaneously three times during the study.<br>* Other names: CERC-002, AEVI-002, MDGN-002;|
| Placebo Comparator: Placebo<br>Approximately 40 subjects will receive placebo sourced as normal saline three times during the study. | Drug: Placebo<br>* Placebo sourced as normal saline administered subcutaneously three times during the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the ability of AVTX-002 to improve asthma control in subjects with poorly controlled non-eosinophilic asthma (NEA) based on the proportion of patients who experience asthma related events. | Proportion of patients who experience any of the following asthma related events: ≥6 additional reliever puffs of Short-Acting Beta-Agonist (compared to baseline) in a 24-hour period on 2 consecutive days or, increase in inhaled corticosteroid dose ≥4 times than the dose at baseline or, a decrease in peak flow of 30% or more (compared to baseline) on 2 consecutive days of treatment, or an asthma exacerbation requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days, or a hospitalization or emergency room visit because of an asthma exacerbation | Through Week 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of AVTX-002. | Change from baseline in forced expiratory volume in 1 second (FEV1) | Through Week 14 | 
| To assess the safety and tolerability of AVTX-002. | Time to asthma exacerbation | Through Week 14 | 
| To assess the safety and tolerability of AVTX-002. | Change from baseline in fractional exhaled nitric oxide (FeNO) | Through Week 14 | 
| To assess the safety and tolerability of AVTX-002. | Change from baseline in Asthma Control Questionnaire (ACQ) | Through Week 14 | 
| To assess the safety and tolerability of AVTX-002. | Change from baseline in Standardized Asthma Quality of Life Questionnaire for 12 years and older (AQLQ(S)+12) | Through Week 14 | 
| To assess the safety and tolerability of AVTX-002. | Change from baseline in Asthma Symptom Diary Score | Through Week 14 | 
| To assess the safety and tolerability of AVTX-002. | Change from baseline in European Quality of Life - 5 Dimension 5 level Questionnaire | Through Week 14 | 
| To assess the safety and tolerability of AVTX-002. | Change from baseline in Patient Global Impression of Change/Severity | Through Week 14 | 
| To assess the safety and tolerability of AVTX-002. | Change from baseline in Clinician Global Impression of Improvement/Severity | Through Week 14 | 
| To assess the safety and tolerability of AVTX-002. | Incidence of short-acting beta agonist (SABA) use | Through Week 14 | 
| To assess the safety and tolerability of AVTX-002. | Safety and tolerability will be assessed by incidence of adverse events (AEs). Clinically significant changes from baseline in clinical laboratory tests, vital signs, and physical examinations will be recorded as AEs. | Through Week 14 | 
| To evaluate biomarkers of pharmacodynamic (PD) activity and mechanism of action of AVTX-002. | Change from baseline in serum soluble LIGHT levels | Through Week 14 | 
| To evaluate the immunogenicity of AVTX-002. | Incidence of anti-drug antibodies (ADAs) | Through Week 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AVTX-002, Non-Eosinophilic Asthma