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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AVTX-002 | Experimental | Approximately 40 subjects will receive AVTX-002 at a dose of 600 mg three times during the study. |
|
| Placebo | Placebo Comparator | Approximately 40 subjects will receive placebo sourced as normal saline three times during the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVTX-002 | Drug | Dose of 600 mg administered subcutaneously three times during the study. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Through Week 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through Week 14 |
| Time to Asthma Exacerbation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Garry Neil, MD | Avalo Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson Neuroscience Research - M3, Wake Research | Tucson | Arizona | 85710 | United States | ||
| Center For Clinical Trials of Sacramento |
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| ID | Title | Description |
|---|---|---|
| FG000 | AVTX-002 | AVTX-002: Dose of 600 mg administered subcutaneously three times during the study. |
| FG001 | Placebo | Placebo: Placebo sourced as normal saline administered subcutaneously three times during the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 17, 2022 | May 8, 2024 |
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| Placebo | Drug | Placebo sourced as normal saline administered subcutaneously three times during the study. |
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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. |
| 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. | 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). | 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"). | 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. | 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'. | 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). | 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). | 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. | 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. | 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. | Baseline, Week 2, Week 4, Week 6, Week 8, Week 12 and Week 14. |
| Sacramento |
| California |
| 95823 |
| United States |
| Allergy and Asthma Medical Group of the Bay Area | Walnut Creek | California | 94598 | United States |
| Center For Clinical Trials of San Gabriel | West Covina | California | 91790-3402 | United States |
| IMMUNOe Research Centers | Centennial | Colorado | 80112 | United States |
| National Jewish Health | Denver | Colorado | 80206 | United States |
| Helix Biomedics, LLC | Boynton Beach | Florida | 33435 | United States |
| Suncoast Research Group LLC | Miami | Florida | 33135 | United States |
| Suncoast Research Associates LLC | Miami | Florida | 33137 | United States |
| Pro-Care Research Center, Corp. | Miami Gardens | Florida | 33014 | United States |
| Innovation Medical Research Center | Palmetto Bay | Florida | 33157 | United States |
| ASHA Clinical Research-Munster, LLC | Hammond | Indiana | 46324 | United States |
| Family Allergy and Asthma Research Institute | Louisville | Kentucky | 40215 | United States |
| Continental Clinical Solutions, LLC | Towson | Maryland | 21212 | United States |
| Pulmonary Research Institute of Southeast Michigan | Farmington Hills | Michigan | 48336 | United States |
| Midwest Clinical Research | St Louis | Missouri | 63141 | United States |
| Meridian Clinical Research | Lincoln | Nebraska | 68510 | United States |
| OK Clinical Research | Edmond | Oklahoma | 73034 | United States |
| Affinity Health | Nashville | Tennessee | 37203 | United States |
| Amarillo Center For Clinical Research | Amarillo | Texas | 79124 | United States |
| South Texas Medical Research Institute, Inc | Boerne | Texas | 78006 | United States |
| Pioneer Research Solutions | Houston | Texas | 77099 | United States |
| Meridian Clinical Research | Portsmouth | Virginia | 23703 | United States |
| Clinical Research Partners, LLC | Richmond | Virginia | 23226 | United States |
| Safety Analysis Set |
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| Full Analysis Set |
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| Per Protocol Analysis Set |
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| PK Analysis Set |
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| COMPLETED |
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| NOT COMPLETED |
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Randomized Analysis Set
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| ID | Title | Description |
|---|---|---|
| BG000 | AVTX-002 | AVTX-002: Dose of 600 mg administered subcutaneously three times during the study. |
| BG001 | Placebo | Placebo: Placebo sourced as normal saline administered subcutaneously three times during the study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Weight | Mean | Standard Deviation | kg |
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| Height | Mean | Standard Deviation | cm |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Screening eosinophil level | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Percentage of patients who experience any of the following asthma related events:
| Full Analysis Set | Posted | Count of Participants | Participants | Through Week 14 |
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| |||||||||||||||||||||||||||||
| Secondary | 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. | Full Analysis Set with all subjects with baseline and Week 14 data available. | Posted | Mean | Standard Deviation | Liter | Through Week 14 |
|
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| Secondary | 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. | Full Analysis Set | Posted | Mean | Standard Deviation | days | Through Week 14 |
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| Secondary | 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. | Full Analysis Set with all subjects with baseline and Week 14 data available. | Posted | Mean | Standard Deviation | Parts per billion | Through Week 14 |
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| Secondary | 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). | Full Analysis Set with all subjects with baseline and Week 14 data available. | Posted | Mean | Standard Deviation | score on a scale | Through Week 14 |
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| Secondary | 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"). | Full Analysis Set with all subjects with baseline and Week 14 data available. | Posted | Mean | Standard Deviation | score on a scale | Through Week 14 |
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| Secondary | 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. | Full Analysis Set with all subjects with baseline and Week 14 data available. | Posted | Mean | Standard Deviation | units on a scale | Through Week 14 |
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| Secondary | 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'. | Full Analysis Set with all subjects with baseline and Week 14 data available. | Posted | Mean | Standard Deviation | units on a scale | Through Week 14 |
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| Secondary | 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). | Full Analysis Set with all subjects with baseline and Week 14 data available. | Posted | Mean | Standard Deviation | units on a scale | Through Week 14 |
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| Secondary | 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). | Full Analysis Set with all subjects with baseline and Week 14 data available. | Posted | Mean | Standard Deviation | units on a scale | Through Week 14 |
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| Secondary | 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. | Full Analysis Set with all subjects with baseline and Week 14 data available. | Posted | Mean | Standard Deviation | number of inhalations | Through Week 14 |
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| Secondary | 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. | Full Analysis Set with all subjects with baseline and Week 14 data available. | Posted | Mean | Standard Deviation | pg/mL | Through Week 14 |
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| Secondary | 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. | Safety Analysis Set: Data only collected for "AVTX-002" Arm/Group. | Posted | Count of Participants | Participants | Baseline, Week 2, Week 4, Week 6, Week 8, Week 12 and Week 14. |
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Treatment emergent AEs were collected from the time of first dose through week 14 (14 weeks total).
An AE will be considered treatment emergent if it occurs on or after the time (or date, if time not recorded) of first dose of IP and within 28 days after a subject's last dose of IP.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AVTX-002 | AVTX-002: Dose of 600 mg administered subcutaneously three times during the study. | 0 | 45 | 0 | 45 | 19 | 45 |
| EG001 | Placebo | Placebo: Placebo sourced as normal saline administered subcutaneously three times during the study. | 0 | 45 | 0 | 45 | 21 | 45 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Food poisoning | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Oesophageal obstruction | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Injection site pain | General disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 24.1 | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
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| Bronchitis bacterial | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
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| Gastrointestinal viral infection | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
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| Blood cholesterol increased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
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| Blood urine present | Investigations | MedDRA 24.1 | Non-systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
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| Blood potassium decreased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Garry Neil, MD | Avalo Therapeutics, Inc. | 610.254.4201 | gneil@avalotx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 2, 2023 | May 8, 2024 | SAP_001.pdf |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| >= 150 eosinophils per micro liter |
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