A Double Masked, Placebo Controlled, Single Center, Randomized Clinical Trial to Assess the Safety and Efficacy of Subjects With Mild Asthma Induced by the Bronchial Allergen Challenge (BAC)

Phase 2

Completed

• Conditions: Atopic Asthma
• Interventions: Drug: Placebo; Drug: ADX-629

• Registration Number: NCT04728711
• Lead Sponsor: Aldeyra Therapeutics, Inc.

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-09
• Study First Submitted: 2021-01-25
• Study First Submitted QC: 2021-01-25
• Study First Posted: 2021-01-28
• Primary Completion: 2022-01-18
• Study Completion: 2022-01-18
• Status Verified: 2023-01
• Disposition First Submitted: 2023-01-09
• Disposition First Submitted QC: 2023-01-09
• Disposition First Posted: 2023-01-12
• Results First Submitted: 2025-01-28
• Results First Submitted QC: 2025-01-28
• Last Update Submitted: 2025-01-28
• Results First Posted: 2025-02-17
• Last Update Posted: 2025-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Male or non-pregnant female, between 18 to 65 years of age (inclusive) at Screening Visit.
• Subjects must give their signed and dated written informed consent (in English) to participate prior to commencing any study-related activities and must be willing to comply with study procedures, study restrictions, study protocol, and return for the required assessments.
• Female subjects of either non-childbearing potential or of child-bearing potential who commit to consistent and correct use of at least one highly effective or two effective forms of contraception starting at least 4 weeks prior to the Screening Visit and for at least 30 days post last dose of study drug.
• Generally healthy subjects with mild controlled asthma for 2 years at Screening Visit according to the Global Initiative for Asthma criteria.

Exclusion Criteria

• History and presence of clinically significant cardiovascular, renal, neurologic, hepatologic, endocrinologic, gastrointestinal, genitourinary, autoimmune, hematological, or metabolic disease other than asthma, which in the opinion of Investigator may either put the subject at risk or influence the results during the study.
• Positive skin prick test to other perennial allergens (i.e., mold, dog with ≥ 3 mm wheal compared to negative control). Subjects with seasonal allergy symptoms that occur or are anticipated to occur during the study should result in subject exclusion or rescheduling until the subject is out of the allergy season.
• Any relevant pulmonary disease within 1 year prior to dosing at the discretion of the investigator.
• Recent hospitalization with asthma in the last 6 months or any other medical condition that the Investigator deems incompatible with participation in the trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo, 600 mg administered orally twice daily (PO bid) for minimum 1 week	Placebo	-
ADX-629, 600 mg administered orally twice daily (PO bid) for a minimum of 1 week	ADX-629	-

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Serious Adverse Events	The safety assessment period was Day 1 - Day 7 for each treatment intervention.	Safety was assessed through serious adverse event collection.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in the Asthma Control Questionnaire	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 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.
Change From Baseline in Sputum Eosinophils Percentage of Total Leukocytes	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 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.
Change From Baseline in Sputum Neutrophils Percentage of Total Leukocytes	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 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.

Trial Locations

Locations (1)

Cliantha Research; 🇨🇦 Mississauga, Ontario, Canada