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 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
The Ability of AVTX-002 to Improve Asthma Control in Subjects With Poorly Controlled Non-eosinophilic Asthma (NEA) Based on the Percentage of Patients Who Experience Asthma Related Events.	Percentage 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
Change From Baseline to Week 14 in Forced Expiratory Volume in 1 Second (FEV1[Liters]).	The FEV1 is the volume of air that can be forcibly exhaled from the lungs in the first second, measured in liters by a spirometer.	Through Week 14
Time to Asthma Exacerbation.	Time to event will be measured in days using the first day of the event to denote the day of the overall asthma related event occurrence.	Through Week 14
Change From Baseline to Week 14 in Fractional Exhaled Nitric Oxide (FeNO).	A FeNO test measures the levels of nitric oxide during exhalation. A FeNO test will be done by breathing into a tube attached to a hand-held monitor.	Through Week 14
Change From Baseline to Week 14 in Asthma Control Questionnaire (ACQ).	This is a simple questionnaire to measure the adequacy of asthma control and change in asthma control. ACQ has a multidimensional construct assessing symptoms (5 items, self-administered), rescue bronchodilator use (1 item, self-administered), and FEV1 (1 item, completed by study staff). Scores range between 0 (totally controlled) and 6 (severely uncontrolled).	Through Week 14
Change From Baseline to Week 14 in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12).	The AQLQ(S)+12 is a modified version of the standardized AQLQ and includes 32 questions in 4 domains (symptoms, activity limitation, emotional function, and environmental stimuli). Subjects will be asked to recall their experiences during the previous 2 weeks and score each of the questions on a 7-point scale, where 7=not at all limited and 1=totally limited. The overall score of the AQLQ +12 will be derived as the average of the 32 questions; thus, the total score ranges from 1 (indicates "total impairment") to 7 (indicates "no impairment").	Through Week 14
Change From Baseline to Week 14 in Asthma Symptom Diary Score.	The Asthma Symptom Diary is a 6-item daily measure of asthma symptom severity that assesses three core categories of asthma symptoms: breathing symptoms (difficulty breathing; wheezing; shortness of breath), chest symptoms (chest tightness; chest pain), and cough. Subjects are required to rate the 6 symptoms at their worst each day using an 11-point numeric rating scale ranging from 0 ('None') to 10 ('As bad as you can imagine'). The Asthma Symptom Diary score is the sum of the 6 individual symptom scores (the range is from 0-60, where a higher score indicates more severe symptoms) reported as a weekly average.	Through Week 14
Change From Baseline to Week 14 in European Quality of Life - 5 Dimension 5 Level Questionnaire in Visual Analogue Scale Score (EQ VAS).	The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ VAS. The EQ VAS records the subject's self-rated health on a vertical VAS with a score of 0-100, where the endpoints are labelled 0 for 'The worst health you can imagine' and 100 for 'The best health you can imagine'.	Through Week 14
Change From Baseline to Week 14 in Patient Global Impression of Change/Severity.	The Patient Global Impression of Change (PGI-C) is a single question scale asking the patient to rate the overall status of their specific condition on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). The Patient Global Impression of Severity (PGI-S) is a single question scale asking the patient to rate current state of their specific condition on a 7-point scale ranging from 1 (normal) to 7 (extreme).	Through Week 14
Change From Baseline to Week 14 in Clinician Global Impression of Improvement/Severity.	The Clinician Global Impression of Improvement (CGI-I) is a single question scale asking clinician to rate the overall status of the patient's specific condition on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). The Clinician Global Impression of Severity (CGI-S) is a single question scale asking the clinician to rate current state of the patient's specific condition on a 7-point scale ranging from 1 (normal) to 7 (extreme).	Through Week 14
The Number of Inhalations of Short-acting Beta Agonist (SABA) at Week 14.	The number of times a short-acting beta agonist (number of inhalations) was used was assessed daily and reported as a weekly average.	Through Week 14
Change From Baseline to Week 14 in Serum Soluble LIGHT Levels (Lymphotoxin-like, Exhibits Inducible Expression, and Competes With Herpes Virus Glycoprotein D for Herpesvirus Entry Mediator, a Receptor Expressed by T Lymphocytes).	Change from baseline in serum soluble LIGHT levels.	Through Week 14
Incidence of Anti-drug Antibodies (ADAs) at Each Timepoint.	Incidence of anti-drug antibodies (ADAs) at Baseline, Week 2, Week 4, Week 6, Week 8, Week 12 and Week 14.	Baseline, Week 2, Week 4, Week 6, Week 8, Week 12 and 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 (Estimated): September 5, 2024
• Last Update Submitted That Met QC Criteria: August 29, 2024
• Last Verified: August 1, 2024

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