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)

Aldeyra Therapeutics, Inc.1 site in 1 country8 target enrollmentJanuary 9, 2021

ConditionsAtopic Asthma

InterventionsADX-629 Placebo

DrugsADX-629 Placebo

Overview

Phase: Phase 2
Intervention: ADX-629
Conditions: Atopic Asthma
Sponsor: Aldeyra Therapeutics, Inc.
Enrollment: 8
Locations: 1
Primary Endpoint: Number of Subjects With Serious Adverse Events
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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)

Registry

clinicaltrials.gov

Start Date

January 9, 2021

End Date

January 18, 2022

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Aldeyra Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

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

Intervention: ADX-629

Placebo, 600 mg administered orally twice daily (PO bid) for minimum 1 week

Intervention: Placebo

Outcomes

Primary Outcomes

Number of Subjects With Serious Adverse Events

Time Frame: The safety assessment period was Day 1 - Day 7 for each treatment intervention.

Safety was assessed through serious adverse event collection.

Secondary Outcomes

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 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 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.)