Non-Eosinophilic AsthmaPhase 2NCT05288504
A Study to Evaluate the Safety and Efficacy of AVTX-002 for the Treatment of Poorly Controlled Non-Eosinophilic Asthma.
A Phase 2 study testing AVTX-002 in people with Non-Eosinophilic Asthma, run by Avalo Therapeutics, Inc. at 24 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Eosinophilic Asthma
- What is being tested?
- AVTX-002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 24 sitesUnited States
- Study dates
- 24 Feb 2022to 11 May 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Amarillo Center For Clinical Research
Amarillo, Texas, 79124
South Texas Medical Research Institute, Inc
Boerne, Texas, 78006
Helix Biomedics, LLC
Boynton Beach, Florida, 33435
IMMUNOe Research Centers
Centennial, Colorado, 80112
National Jewish Health
Denver, Colorado, 80206
OK Clinical Research
Edmond, Oklahoma, 73034
Pulmonary Research Institute of Southeast Michigan
Farmington Hills, Michigan, 48336
ASHA Clinical Research-Munster, LLC
Hammond, Indiana, 46324
Pioneer Research Solutions
Houston, Texas, 77099
Meridian Clinical Research
Lincoln, Nebraska, 68510
Family Allergy and Asthma Research Institute
Louisville, Kentucky, 40215
Suncoast Research Group LLC
Miami, Florida, 33135
Suncoast Research Associates LLC
Miami, Florida, 33137
Pro-Care Research Center, Corp.
Miami Gardens, Florida, 33014
Affinity Health
Nashville, Tennessee, 37203
Innovation Medical Research Center
Palmetto Bay, Florida, 33157
Meridian Clinical Research
Portsmouth, Virginia, 23703
Clinical Research Partners, LLC
Richmond, Virginia, 23226
Center For Clinical Trials of Sacramento
Sacramento, California, 95823
Midwest Clinical Research
St Louis, Missouri, 63141
Continental Clinical Solutions, LLC
Towson, Maryland, 21212
Tucson Neuroscience Research - M3, Wake Research
Tucson, Arizona, 85710
Allergy and Asthma Medical Group of the Bay Area
Walnut Creek, California, 94598
Center For Clinical Trials of San Gabriel
West Covina, California, 91790-3402
About this study
Official 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
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
- Being tested
- AVTX-002, Placebo
- Keywords
- Non-Eosinophilic Asthma, AVTX-002
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVTX-002Drug
Also called CERC-002, AEVI-002, MDGN-002
Dose of 600 mg administered subcutaneously three times during the study.
PlaceboDrug
Placebo sourced as normal saline administered subcutaneously three times during the study.
| Study group | Role | What they receive |
|---|---|---|
| AVTX-002 | Experimental | Approximately 40 subjects will receive AVTX-002 at a dose of 600 mg three times during the study. Receives: Drug: AVTX-002 |
| Placebo | Placebo comparator | Approximately 40 subjects will receive placebo sourced as normal saline three times during the study. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through Week 14
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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").
Measured: 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.
Measured: 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'.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 2, Week 4, Week 6, Week 8, Week 12 and Week 14.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start24 Feb 2022
- Primary completion11 May 2023
- Study completion11 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Eosinophilic AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avalo Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Garry Neil, MD, Study director, Avalo Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288504
- Sponsor's protocol ID
- AVTX-002-NEA-201
- Status last verified
- Aug 2024
- First submitted
- 8 Mar 2022
- Last updated
- 5 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05288504
- Acronym / sponsor ID
- AVTX-002-NEA-201
- Conditions
- Non-Eosinophilic Asthma
- Keywords
- Non-Eosinophilic Asthma, AVTX-002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Avalo Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 11 May 2023 (actual)
- Study completion
- 11 May 2023 (actual)
- First posted
- 21 Mar 2022 (actual)
- Results
- Posted 5 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AVTX-002 | Experimental | Drug: AVTX-002Approximately 40 subjects will receive AVTX-002 at a dose of 600 mg three times during the study. |
| Placebo | Placebo comparator | Drug: PlaceboApproximately 40 subjects will receive placebo sourced as normal saline three times during the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVTX-002Also: CERC-002, AEVI-002, MDGN-002Dose of 600 mg administered subcutaneously three times during the study. | Drug | AVTX-002 |
| PlaceboPlacebo sourced as normal saline administered subcutaneously three times during the study. | Drug | Placebo |
Primary outcome
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
12 secondary outcomes
Change From Baseline to Week 14 in Forced Expiratory Volume in 1 Second (FEV1[Liters]).
Time frame: Through Week 14
Time to Asthma Exacerbation.
Time frame: Through Week 14
Change From Baseline to Week 14 in Fractional Exhaled Nitric Oxide (FeNO).
Time frame: Through Week 14
Change From Baseline to Week 14 in Asthma Control Questionnaire (ACQ).
Time frame: Through Week 14
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
Change From Baseline to Week 14 in Asthma Symptom Diary Score.
Time frame: 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).
Time frame: Through Week 14
Change From Baseline to Week 14 in Patient Global Impression of Change/Severity.
Time frame: Through Week 14
Change From Baseline to Week 14 in Clinician Global Impression of Improvement/Severity.
Time frame: Through Week 14
The Number of Inhalations of Short-acting Beta Agonist (SABA) at Week 14.
Time frame: 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).
Time frame: Through Week 14
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Garry Neil, MD study director
Avalo Therapeutics, Inc.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AVTX-002 in people with Non-Eosinophilic Asthma, run by Avalo Therapeutics, Inc. at 24 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.