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Completed

NCT Number: NCT05288504

A 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).

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Key information

Conditions

Non-Eosinophilic Asthma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tucson Neuroscience Research - M3, Wake Research, Tucson, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AVTX-002

Drug

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

Other names: CERC-002, AEVI-002, MDGN-002

Placebo

Drug

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

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.

    Time frame: Through Week 14

    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

Secondary outcomes

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

    Time frame: Through Week 14

    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.

  2. Time to Asthma Exacerbation.

    Time frame: Through Week 14

    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.

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

    Time frame: Through Week 14

    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.

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

    Time frame: Through Week 14

    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).

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

    Time frame: Through Week 14

    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").

  6. Change From Baseline to Week 14 in Asthma Symptom Diary Score.

    Time frame: Through Week 14

    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.

  7. Change From Baseline to Week 14 in European Quality of Life - 5 Dimension 5 Level Questionnaire in Visual Analogue Scale Score (EQ VAS).

    Time frame: Through Week 14

    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'.

  8. Change From Baseline to Week 14 in Patient Global Impression of Change/Severity.

    Time frame: Through Week 14

    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).

  9. Change From Baseline to Week 14 in Clinician Global Impression of Improvement/Severity.

    Time frame: Through Week 14

    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).

  10. The Number of Inhalations of Short-acting Beta Agonist (SABA) at Week 14.

    Time frame: Through 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.

  11. 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).

    Time frame: Through Week 14

    Change from baseline in serum soluble LIGHT levels.

  12. Incidence of Anti-drug Antibodies (ADAs) at Each Timepoint.

    Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 12 and Week 14.

    Incidence of anti-drug antibodies (ADAs) at Baseline, Week 2, Week 4, Week 6, Week 8, Week 12 and Week 14.

Sponsors and collaborators

Lead sponsor

Avalo Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 21, 2022
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.