A Phase 2 interventional study of AVTX-002 and Placebo in Non-Eosinophilic Asthma, sponsored by Avalo Therapeutics, Inc.. Completed at 24 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-05.
Sponsored by Avalo Therapeutics, Inc. · Phase 2, Interventional, and Treatment
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).
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's enrollment of 91 is above the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →Avalo Therapeutics, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Approximately 40 subjects will receive AVTX-002 at a dose of 600 mg three times during the study.
Drug: AVTX-002
Approximately 40 subjects will receive placebo sourced as normal saline three times during the study.
Drug: Placebo
Dose of 600 mg administered subcutaneously three times during the study.
Also known as: CERC-002, AEVI-002, MDGN-002
Placebo sourced as normal saline administered subcutaneously three times during the study.
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
Time frame: Through Week 14
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
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).
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").
Time frame: 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.
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).
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'.
Time frame: 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).
Time frame: 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).
Time frame: 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.
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).
Change from baseline in serum soluble LIGHT levels.
Time frame: 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.
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 12 and Week 14.
| Milestone | AVTX-002 | Placebo |
|---|---|---|
| Started | 45 | 46 |
| Safety analysis set | 45 | 45 |
| Full analysis set | 45 | 45 |
| Per protocol analysis set | 43 | 41 |
| Pk analysis set | 45 | 0 |
| Completed | 36 | 32 |
| Not completed | 9 | 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
| Participants | AVTX-002 | 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. | 12 | 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.
| Liter | AVTX-002 | Placebo |
|---|---|---|
| Change From Baseline to Week 14 in Forced Expiratory Volume in 1 Second (FEV1[Liters]). | -0.149 ± 0.309 | -0.203 ± 0.405 |
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.
| days | AVTX-002 | Placebo |
|---|---|---|
| Time to first asthma related event or time to censoring | 84.9 ± 28.03 | 78.1 ± 30.58 |
| Time to first asthma related event - Subjects with an asthma related event | 52.1 ± 31.83 | 42.6 ± 26.69 |
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.
| Parts per billion | AVTX-002 | Placebo |
|---|---|---|
| Change From Baseline to Week 14 in Fractional Exhaled Nitric Oxide (FeNO). | 6.1 ± 15.54 | 3.8 ± 27.64 |
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).
| score on a scale | AVTX-002 | Placebo |
|---|---|---|
| Change From Baseline to Week 14 in Asthma Control Questionnaire (ACQ). | -0.22 ± 1.077 | -0.34 ± 0.999 |
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").
| score on a scale | AVTX-002 | Placebo |
|---|---|---|
| Change From Baseline to Week 14 in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12). | 0.18 ± 1.423 | 0.49 ± 1.162 |
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.
| units on a scale | AVTX-002 | Placebo |
|---|---|---|
| Change From Baseline to Week 14 in Asthma Symptom Diary Score. | -0.15 ± 1.469 | -0.39 ± 1.318 |
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'.
| units on a scale | AVTX-002 | Placebo |
|---|---|---|
| Change From Baseline to Week 14 in European Quality of Life - 5 Dimension 5 Level Questionnaire in Visual Analogue Scale Score (EQ VAS). | 2.9 ± 22.60 | 5.6 ± 15.28 |
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).
| units on a scale | AVTX-002 | Placebo |
|---|---|---|
| PGI-S | 0.0 ± 1.28 | -0.4 ± 1.31 |
| PGI-C | 3.4 ± 1.50 | 3.0 ± 1.63 |
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).
| units on a scale | AVTX-002 | Placebo |
|---|---|---|
| CGI-S | -0.3 ± 0.86 | -0.5 ± 1.33 |
| CGI-I | 3.4 ± 1.32 | 3.2 ± 1.52 |
The number of times a short-acting beta agonist (number of inhalations) was used was assessed daily and reported as a weekly average.
| number of inhalations | AVTX-002 | Placebo |
|---|---|---|
| The Number of Inhalations of Short-acting Beta Agonist (SABA) at Week 14. | 1.28 ± 1.507 | 0.97 ± 1.695 |
Change from baseline in serum soluble LIGHT levels.
| pg/mL | AVTX-002 | Placebo |
|---|---|---|
| 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). | -114.52 ± 80.781 | 11.63 ± 92.147 |
Incidence of anti-drug antibodies (ADAs) at Baseline, Week 2, Week 4, Week 6, Week 8, Week 12 and Week 14.
| Participants | AVTX-002 | Placebo |
|---|---|---|
| Baseline | 0 | — |
| Week 2 | 1 | — |
| Week 4 | 0 | — |
| Week 6 | 0 | — |
| Week 8 | 0 | — |
| Week 12 | 0 | — |
| Week 14 | 0 | — |
Collected over Treatment emergent AEs were collected from the time of first dose through week 14 (14 weeks total).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AVTX-002 | 0/45 (0%) | 0/45 (0%) | 19/45 (42.2%) |
| Placebo | 0/45 (0%) | 0/45 (0%) | 21/45 (46.7%) |
| Event | AVTX-002 | Placebo |
|---|---|---|
| ArthralgiaMusculoskeletal and connective tissue disorders | 3/45 | 0/45 |
| MyalgiaMusculoskeletal and connective tissue disorders | 3/45 | 1/45 |
| Injection site painGeneral disorders | 2/45 | 0/45 |
| COVID-19Infections and infestations | 2/45 | 2/45 |
| NasopharyngitisInfections and infestations | 2/45 | 0/45 |
| Upper respiratory tract infectionInfections and infestations | 2/45 | 2/45 |
| Blood creatine phosphokinase increasedInvestigations | 0/45 | 2/45 |
| DiarrhoeaGastrointestinal disorders | 1/45 | 0/45 |
| Food poisoningGastrointestinal disorders | 1/45 | 0/45 |
| Oesophageal obstructionGastrointestinal disorders | 1/45 | 0/45 |
Randomized Analysis Set
| Age, Continuous(years) | AVTX-002 | Placebo | Total |
|---|---|---|---|
| Mean | 45.5 ± 14.60 | 47.6 ± 15.99 | 46.6 ± 15.27 |
| Sex: Female, Male(Participants) | AVTX-002 | Placebo | Total |
|---|---|---|---|
| Female | 28 | 32 | 60 |
| Male | 17 | 14 | 31 |
| Ethnicity (NIH/OMB)(Participants) | AVTX-002 | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 14 | 12 | 26 |
| Not Hispanic or Latino | 31 | 34 | 65 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | AVTX-002 | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 17 | 10 | 27 |
| White | 28 | 35 | 63 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | AVTX-002 | Placebo | Total |
|---|---|---|---|
| United States | 45 | 46 | 91 |
| Weight(kg) | AVTX-002 | Placebo | Total |
|---|---|---|---|
| Mean | 95.60 ± 23.661 | 87.94 ± 21.343 | 91.73 ± 22.722 |
| Height(cm) | AVTX-002 | Placebo | Total |
|---|---|---|---|
| Mean | 168.41 ± 9.900 | 167.69 ± 10.865 | 168.04 ± 10.347 |
| BMI(kg/m^2) | AVTX-002 | Placebo | Total |
|---|---|---|---|
| Mean | 33.95 ± 8.917 | 31.20 ± 6.329 | 32.56 ± 7.798 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2022 to primary completion in May 2023, 14 months.
Results were first posted in Sep 2024, 1 year 3 months after primary completion.
Of 137 industry-sponsored phase 2 interventional studies under Asthma, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 23. This study's 14 months is below that.
Counting every sponsor, half of 198 studies reached it within 20 months; a quarter within 12 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Quisovalimab
Avalo Therapeutics, Inc.