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

NCT05288504 | Completed Phase 2 Results FDA Drug

• 1 other identifier: AVTX-002-NEA-201
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 24

Brief 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).

Conditions

Non-Eosinophilic Asthma

Keywords

Non-Eosinophilic Asthma; AVTX-002

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Change From Baseline to Week 14 in Forced Expiratory Volume in 1 Second (FEV1[Liters]).

  Through Week 14

• Time to Asthma Exacerbation.

  Through Week 14

• Change From Baseline to Week 14 in Fractional Exhaled Nitric Oxide (FeNO).

  Through Week 14

• Change From Baseline to Week 14 in Asthma Control Questionnaire (ACQ).

  Through Week 14

• Change From Baseline to Week 14 in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12).

  Through Week 14

Study Arms (2)

AVTX-002

EXPERIMENTAL

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

Drug: AVTX-002

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

AVTX-002 DRUG

Dose of 600 mg administered subcutaneously three times during the study.

Also known as: CERC-002, AEVI-002, MDGN-002

AVTX-002

Placebo DRUG

Placebo sourced as normal saline administered subcutaneously three times during the study.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Avalo Therapeutics, Inc.: lead

Study Sites (24)

Tucson Neuroscience Research - M3, Wake Research

Tucson, Arizona, 85710, United States

Location

Center For Clinical Trials of Sacramento

Sacramento, California, 95823, United States

Location

Allergy and Asthma Medical Group of the Bay Area

Walnut Creek, California, 94598, United States

Location

Center For Clinical Trials of San Gabriel

West Covina, California, 91790-3402, United States

Location

IMMUNOe Research Centers

Centennial, Colorado, 80112, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Helix Biomedics, LLC

Boynton Beach, Florida, 33435, United States

Location

Suncoast Research Group LLC

Miami, Florida, 33135, United States

Location

Suncoast Research Associates LLC

Miami, Florida, 33137, United States

Location

Pro-Care Research Center, Corp.

Miami Gardens, Florida, 33014, United States

Location

Innovation Medical Research Center

Palmetto Bay, Florida, 33157, United States

Location

ASHA Clinical Research-Munster, LLC

Hammond, Indiana, 46324, United States

Location

Family Allergy and Asthma Research Institute

Louisville, Kentucky, 40215, United States

Location

Continental Clinical Solutions, LLC

Towson, Maryland, 21212, United States

Location

Pulmonary Research Institute of Southeast Michigan

Farmington Hills, Michigan, 48336, United States

Location

Midwest Clinical Research

St Louis, Missouri, 63141, United States

Location

Meridian Clinical Research

Lincoln, Nebraska, 68510, United States

Location

OK Clinical Research

Edmond, Oklahoma, 73034, United States

Location

Affinity Health

Nashville, Tennessee, 37203, United States

Location

Amarillo Center For Clinical Research

Amarillo, Texas, 79124, United States

Location

South Texas Medical Research Institute, Inc

Boerne, Texas, 78006, United States

Location

Pioneer Research Solutions

Houston, Texas, 77099, United States

Location

Meridian Clinical Research

Portsmouth, Virginia, 23703, United States

Location

Clinical Research Partners, LLC

Richmond, Virginia, 23226, United States

Location

Results Point of Contact

• Title: Garry Neil, MD
• Organization: Avalo Therapeutics, Inc.

gneil@avalotx.com

610.254.4201

Study Officials

• Garry Neil, MD

  Avalo Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 21, 2022
• Study Start: February 24, 2022
• Primary Completion: May 11, 2023
• Study Completion: May 11, 2023
• Last Updated: September 5, 2024
• Results First Posted: September 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (24)