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

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

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).

Study Overview

• Status: Completed
• Conditions: Non-Eosinophilic Asthma
• Intervention / Treatment: Drug: AVTX-002; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Emily Cooke; Phone Number: 484.588.5264; Email: ecooke@avalotx.com
• Study Contact Backup: Name: Lisa Goldberg; Phone Number: 610.975.4480; Email: lgoldberg@avalotx.com

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85710
      • Tucson Neuroscience Research - M3, Wake Research
  • California
    • Sacramento, California, United States, 95823
      • Center for Clinical Trials of Sacramento
    • Walnut Creek, California, United States, 94598
      • Allergy and Asthma Medical Group of the Bay Area
    • West Covina, California, United States, 91790-3402
      • Center for Clinical Trials of San Gabriel
  • Colorado
    • Centennial, Colorado, United States, 80112
      • IMMUNOe Research Centers
    • Denver, Colorado, United States, 80206
      • National Jewish Health
  • Florida
    • Boynton Beach, Florida, United States, 33435
      • Helix Biomedics, LLC
    • Miami, Florida, United States, 33135
      • Suncoast Research Group LLC
    • Miami, Florida, United States, 33137
      • Suncoast Research Associates LLC
    • Miami Gardens, Florida, United States, 33014
      • Pro-Care Research Center, Corp.
    • Palmetto Bay, Florida, United States, 33157
      • Innovation Medical Research Center
  • Indiana
    • Hammond, Indiana, United States, 46324
      • ASHA Clinical Research-Munster, LLC
  • Kentucky
    • Louisville, Kentucky, United States, 40215
      • Family Allergy and Asthma Research Institute
  • Maryland
    • Towson, Maryland, United States, 21212
      • Continental Clinical Solutions, LLC
  • Michigan
    • Farmington Hills, Michigan, United States, 48336
      • Pulmonary Research Institute of Southeast Michigan
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Midwest Clinical Research
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Meridian Clinical Research
  • Oklahoma
    • Edmond, Oklahoma, United States, 73034
      • OK Clinical Research
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Affinity Health
  • Texas
    • Amarillo, Texas, United States, 79124
      • Amarillo Center for Clinical Research
    • Boerne, Texas, United States, 78006
      • South Texas Medical Research Institute, Inc
    • Houston, Texas, United States, 77099
      • Pioneer Research Solutions
  • Virginia
    • Portsmouth, Virginia, United States, 23703
      • Meridian Clinical Research
    • Richmond, Virginia, United States, 23226
      • Clinical Research Partners, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Avalo Therapeutics, Inc.
• Investigators: Study Director: Garry Neil, MD, Avalo Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2022
• Primary Completion (Actual): May 11, 2023
• Study Completion (Actual): May 11, 2023

Study Registration Dates

• First Submitted: March 8, 2022
• First Submitted That Met QC Criteria: March 18, 2022
• First Posted (Actual): March 21, 2022

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Non-Eosinophilic Asthma; AVTX-002
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: AVTX-002-NEA-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No