A Study to Investigate Using Inhaled Fexlamose to Treat Adult Participants Who Have Moderate to Severe COPD

NCT06731959 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: AER-01-002
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

AER-01-002 is a Phase 2a study being conducted to determine if inhaled fexlamose is an effective and safe treatment for adults with moderate to severe COPD. Study will compare active drug to placebo.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• FEV1

  Change from baseline in prebronchodilator FEV1 at Week 4

  4 weeks

Secondary Outcomes (5)

• Incidence of AEs (including SAEs and AESIs) throughout the study

  4 weeks

• Change from baseline in CT mucus plug segment score at Week 4

  4 weeks

• Change from baseline in E-RS:COPD score at Week 4

  4 weeks

• Change from baseline in prebronchodilator FVC at Week 4

  4 weeks

• Change from baseline in SpO2 at Week 4

  4 weeks

Study Arms (2)

Fexlamose

EXPERIMENTAL

Fexlamose solution once daily via nebulizer for 28 days

Drug: Flexlamose

Placebo

PLACEBO COMPARATOR

Placebo solution once daily via nebulizer for 28 days

Drug: Placebo

Interventions

Flexlamose DRUG

Fexlamose solution via nebulizer for 28 days

Fexlamose

Placebo DRUG

Placebo solution via nebulizer for 28 days

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Each participant must meet all the following criteria to be enrolled in this study:
• Participant is male or female ≥40 to ≤80 years of age.
• Participant has a verified diagnosis of cigarette smoking-related COPD FEV1 that is \>25% and \<60% of predicted normal at Visit 1.
• Participant meets the following spirometry performance criteria:
• Acceptability: Participant can perform acceptable spirometry (ie, meet ATS/ERS acceptability criteria) at Visits 1 and 2.
• Repeatability: Participant can perform technically acceptable spirometry meeting repeatability criteria for FEV1 during at least 1 of the prebronchodilator assessments at Visits 1 and 2.
• Participant is on stable maintenance COPD medications with no dose adjustments for ≥4 weeks prior to Screening and during the Screening Period.
• Participant has had ≤2 COPD exacerbations requiring hospitalization in the past year.

You may not qualify if:

• Participants meeting any of the following criteria will be excluded from the study:
• Participant has an active uncontrolled medical condition
• Participant has a diagnosis of current asthma
• Participant has primary diagnosis of bronchiectasis, primary ciliary dyskinesia, allergic bronchopulmonary aspergillosis, or CF.
• Participant has had a COPD exacerbation in the 6 weeks prior to Visit 1
• Participant has active lung infection
• Participant has received any vaccine within 7 days prior to Day 1.
• Participant is taking a protein therapeutic for control of COPD or asthma: eg, dupilumab, tezepelumab, benralizumab, mepolizumab, omalizumab.

Sponsors & Collaborators

• Aer Therapeutics: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jordan Low

CONTACT

4256239331; jordan.low@aertherapeutics.com

Study Design

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

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: December 13, 2024
• Study Start: December 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: January 1, 2026
• Last Updated: December 13, 2024

Record last verified: 2024-12