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)

NCT04728711 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ADX-629-AA-001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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)

Conditions

Atopic Asthma

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (3)

• 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.

Study Arms (2)

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

EXPERIMENTAL

Drug: ADX-629

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

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ADX-629 DRUG

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

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

Placebo DRUG

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

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Aldeyra Therapeutics, Inc.: lead

Study Sites (1)

Cliantha Research

Mississauga, Ontario, L4W 1A4, Canada

Location

MeSH Terms

Interventions

ADX-629

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Aldeyra Therapeutics, Inc.

bcavanagh@aldeyra.com

781-257-3063

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: January 28, 2021
• Study Start: January 9, 2021
• Primary Completion: January 18, 2022
• Study Completion: January 18, 2022
• Last Updated: February 17, 2025
• Results First Posted: February 17, 2025

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)