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A Double Masked, Placebo Controlled, Single Center, Randomized Clinical Trial to Assess the Safety and Efficacy of ADX-629 in Subjects with Mild Asthma Induced by the Bronchial Allergen Challenge (BAC)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADX-629, 600 mg administered orally twice daily (PO bid) for a minimum of 1 week | Experimental |
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| Placebo, 600 mg administered orally twice daily (PO bid) for minimum 1 week | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADX-629 | Drug | ADX-629, 600 mg administered orally twice daily (PO bid) for a minimum of 1 week |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Serious Adverse Events | Safety was assessed through serious adverse event collection. | The safety assessment period was Day 1 - Day 7 for each treatment intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Asthma Control Questionnaire | Change from baseline in the asthma control questionnaire, which is seven questions on a seven-point scale (0 = totally controlled, 6 = extremely poorly controlled). The first six questions are answered by the subject. The seventh question, concerning forced expiratory volume in 1 second (FEV1) percentage predicted (0 = >95% predicted, 6 = <50% predicted), is completed by clinic staff. The asthma control questionnaire is calculated as the mean of the response to all seven questions, with a higher score being more severe. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliantha Research | Mississauga | Ontario | L4W 1A4 | Canada |
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Eight subjects were randomized in a crossover design trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | First ADX-629, Then Placebo | ADX-629 300mg (milligrams) administered orally twice daily for one week, then a two-day washout, then placebo administered orally twice daily for one week. |
| FG001 | First Placebo, Then ADX-629 |
| 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 | May 19, 2021 | Jan 15, 2025 |
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| Placebo | Drug | Placebo, 600 mg administered orally twice daily (PO bid) for minimum 1 week |
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| The efficacy assessment period was Day 1 through Day 7 for each treatment period. Baseline is defined as the last non-missing assessment prior to randomization. |
| Change From Baseline in Sputum Eosinophils Percentage of Total Leukocytes | Change from baseline in sputum eosinophils percentage of total leukocytes at seven hours post bronchial allergen challenge and 24 hours post bronchial allergen challenge. A reduction in sputum eosinophils percentage demonstrates improvement. | The efficacy assessment period was Day 1 through 7 for each treatment period. Baseline is defined as the last non-missing assessment prior to randomization. |
| Change From Baseline in Sputum Neutrophils Percentage of Total Leukocytes | Change from baseline in sputum neutrophils percentage of total leukocytes at 7 hours post bronchial allergen challenge and 24 hours post bronchial allergen challenge. A reduction in sputum neutrophils percentage demonstrates improvement. | The efficacy assessment period was Day 1 through Day 7 for each treatment period. Baseline is defined as the last non-missing assessment prior to randomization. |
Placebo administered orally twice daily for one week, then a two-day washout, then ADX-629 300mg administered orally twice daily for one week.
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| NOT COMPLETED |
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Intent-to-treat population
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| ID | Title | Description |
|---|---|---|
| BG000 | First ADX-629, Then Placebo | ADX-629 300mg administered orally twice daily for one week, then a two-day washout, then placebo administered orally twice daily for one week. |
| BG001 | First Placebo, Then ADX-629 | Placebo administered orally twice daily for one week, then a two-day washout, then ADX-629 300mg administered orally twice daily for one week. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| 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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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
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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 | |||||||||||||||||||||||
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| Primary | Number of Subjects With Serious Adverse Events | Safety was assessed through serious adverse event collection. | Safety population | Posted | Number | participants | The safety assessment period was Day 1 - Day 7 for each treatment intervention. |
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| Secondary | Change From Baseline in the Asthma Control Questionnaire | Change from baseline in the asthma control questionnaire, which is seven questions on a seven-point scale (0 = totally controlled, 6 = extremely poorly controlled). The first six questions are answered by the subject. The seventh question, concerning forced expiratory volume in 1 second (FEV1) percentage predicted (0 = >95% predicted, 6 = <50% predicted), is completed by clinic staff. The asthma control questionnaire is calculated as the mean of the response to all seven questions, with a higher score being more severe. | Intent-to-treat population | Posted | Mean | Standard Deviation | score on a scale | The efficacy assessment period was Day 1 through Day 7 for each treatment period. Baseline is defined as the last non-missing assessment prior to randomization. |
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| Secondary | Change From Baseline in Sputum Eosinophils Percentage of Total Leukocytes | Change from baseline in sputum eosinophils percentage of total leukocytes at seven hours post bronchial allergen challenge and 24 hours post bronchial allergen challenge. A reduction in sputum eosinophils percentage demonstrates improvement. | Intent-to-treat population | Posted | Mean | Standard Deviation | percentage | The efficacy assessment period was Day 1 through 7 for each treatment period. Baseline is defined as the last non-missing assessment prior to randomization. |
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| Secondary | Change From Baseline in Sputum Neutrophils Percentage of Total Leukocytes | Change from baseline in sputum neutrophils percentage of total leukocytes at 7 hours post bronchial allergen challenge and 24 hours post bronchial allergen challenge. A reduction in sputum neutrophils percentage demonstrates improvement. | Intent-to-treat population | Posted | Mean | Standard Deviation | percentage | The efficacy assessment period was Day 1 through Day 7 for each treatment period. Baseline is defined as the last non-missing assessment prior to randomization. |
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One week for each intervention
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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 | ADX-629 | ADX-629 300 milligrams administered orally twice daily for 1 week | 0 | 8 | 0 | 8 | 1 | 8 |
| EG001 | Placebo | Placebo administered orally twice daily for 1 week | 0 | 8 | 0 | 8 | 1 | 8 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Aldeyra Therapeutics, Inc. | 781-257-3063 | bcavanagh@aldeyra.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 14, 2022 | Jan 15, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000716647 | ADX-629 |
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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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