Trial · NCT05288504
A Study to Evaluate the Safety and Efficacy of AVTX-002 for the Treatment of Poorly Controlled Non-Eosinophilic Asthma.
NCT05288504, Phase 2, Completed, Avalo Therapeutics, Inc.; results first posted 2024-09-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Safety and Efficacy of AVTX-002 for the Treatment of Poorly Controlled Non-Eosinophilic Asthma. Trials, record NCT05288504. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05288504
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety and Efficacy of AVTX-002 for the Treatment of Poorly Controlled Non-Eosinophilic Asthma.
- NCT number
- NCT05288504
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 91 participants, actual
- Lead sponsor
- Avalo Therapeutics, Inc.
- Conditions
- Non-Eosinophilic Asthma
- Interventions
- AVTX-002, Placebo
- First posted
- 2022-03-21
- Last updated
- 2024-09-05
- Results first posted
- 2024-09-05
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. | 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 | Change From Baseline to Week 14 in Forced Expiratory Volume in 1 Second (FEV1[Liters]). | 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. |
| Secondary | Time to Asthma Exacerbation. | 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. |
| Secondary | Change From Baseline to Week 14 in Fractional Exhaled Nitric Oxide (FeNO). | 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. |
| Secondary | Change From Baseline to Week 14 in Asthma Control Questionnaire (ACQ). | 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). |
| Secondary | Change From Baseline to Week 14 in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12). | 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"). |
| Secondary | Change From Baseline to Week 14 in Asthma Symptom Diary Score. | 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. |
| Secondary | Change From Baseline to Week 14 in European Quality of Life - 5 Dimension 5 Level Questionnaire in Visual Analogue Scale Score (EQ VAS). | 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'. |
| Secondary | Change From Baseline to Week 14 in Patient Global Impression of Change/Severity. | 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). |
| Secondary | Change From Baseline to Week 14 in Clinician Global Impression of Improvement/Severity. | 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). |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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. | Through Week 14 | Full Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline to Week 14 in Forced Expiratory Volume in 1 Second (FEV1[Liters]). | Through Week 14 | Full Analysis Set with all subjects with baseline and Week 14 data available. | Liter | MEAN |
| SECONDARY | Time to Asthma Exacerbation. | Through Week 14 | Full Analysis Set | days | MEAN |
| SECONDARY | Change From Baseline to Week 14 in Fractional Exhaled Nitric Oxide (FeNO). | Through Week 14 | Full Analysis Set with all subjects with baseline and Week 14 data available. | Parts per billion | MEAN |
| SECONDARY | Change From Baseline to Week 14 in Asthma Control Questionnaire (ACQ). | Through Week 14 | Full Analysis Set with all subjects with baseline and Week 14 data available. | score on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 14 in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12). | Through Week 14 | Full Analysis Set with all subjects with baseline and Week 14 data available. | score on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 14 in Asthma Symptom Diary Score. | Through Week 14 | Full Analysis Set with all subjects with baseline and Week 14 data available. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 14 in European Quality of Life - 5 Dimension 5 Level Questionnaire in Visual Analogue Scale Score (EQ VAS). | Through Week 14 | Full Analysis Set with all subjects with baseline and Week 14 data available. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 14 in Patient Global Impression of Change/Severity. | Through Week 14 | Full Analysis Set with all subjects with baseline and Week 14 data available. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 14 in Clinician Global Impression of Improvement/Severity. | Through Week 14 | Full Analysis Set with all subjects with baseline and Week 14 data available. | units on a scale | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group37
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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. | AVTX-002 | 12 | Participants | ||
| 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. | Placebo | 14 | Participants | ||
| Change From Baseline to Week 14 in Forced Expiratory Volume in 1 Second (FEV1[Liters]). | AVTX-002 | -0.149 | Standard Deviation 0.309 | Liter | |
| Change From Baseline to Week 14 in Forced Expiratory Volume in 1 Second (FEV1[Liters]). | Placebo | -0.203 | Standard Deviation 0.405 | Liter | |
| Time to Asthma Exacerbation. | AVTX-002 | Time to first asthma related event or time to censoring | 84.9 | Standard Deviation 28.03 | days |
| Time to Asthma Exacerbation. | Placebo | Time to first asthma related event or time to censoring | 78.1 | Standard Deviation 30.58 | days |
| Time to Asthma Exacerbation. | AVTX-002 | Time to first asthma related event - Subjects with an asthma related event | 52.1 | Standard Deviation 31.83 | days |
| Time to Asthma Exacerbation. | Placebo | Time to first asthma related event - Subjects with an asthma related event | 42.6 | Standard Deviation 26.69 | days |
| Change From Baseline to Week 14 in Fractional Exhaled Nitric Oxide (FeNO). | AVTX-002 | 6.1 | Standard Deviation 15.54 | Parts per billion | |
| Change From Baseline to Week 14 in Fractional Exhaled Nitric Oxide (FeNO). | Placebo | 3.8 | Standard Deviation 27.64 | Parts per billion |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AVTX-002 | 45 | |
| Overall Study | STARTED | Placebo | 46 | |
| Overall Study | Safety Analysis Set | AVTX-002 | 45 | |
| Overall Study | Safety Analysis Set | Placebo | 45 | |
| Overall Study | Full Analysis Set | AVTX-002 | 45 | |
| Overall Study | Full Analysis Set | Placebo | 45 | |
| Overall Study | Per Protocol Analysis Set | AVTX-002 | 43 | |
| Overall Study | Per Protocol Analysis Set | Placebo | 41 | |
| Overall Study | PK Analysis Set | AVTX-002 | 45 | |
| Overall Study | PK Analysis Set | Placebo | 0 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events70
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | AVTX-002 | 1 | 45 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 0 | 45 | 0 |
| other | Food poisoning | Gastrointestinal disorders | AVTX-002 | 1 | 45 | 1 |
| other | Food poisoning | Gastrointestinal disorders | Placebo | 0 | 45 | 0 |
| other | Oesophageal obstruction | Gastrointestinal disorders | AVTX-002 | 1 | 45 | 1 |
| other | Oesophageal obstruction | Gastrointestinal disorders | Placebo | 0 | 45 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | AVTX-002 | 0 | 45 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 1 | 45 | 1 |
| other | Toothache | Gastrointestinal disorders | AVTX-002 | 0 | 45 | 0 |
| other | Toothache | Gastrointestinal disorders | Placebo | 1 | 45 | 1 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AVTX-002 | 0 | 45 |
| Total, all-cause mortality | Placebo | 0 | 45 |
| Total, other adverse events | AVTX-002 | 19 | 45 |
| Total, other adverse events | Placebo | 21 | 45 |
| Total, serious adverse events | AVTX-002 | 0 | 45 |
| Total, serious adverse events | Placebo | 0 | 45 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
AVTX-002 vs Placebo: 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. | Trial comparisons |
| AVTX-002 vs Placebo: deaths from any cause | Trial comparisons |
| AVTX-002 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05288504
GET https://conductscience.org/api/trials/v1/NCT05288504/results?page=2