A Study to Investigate Using Inhaled Fexlamose to Treat Adult Participants Who Have Moderate to Severe COPD (AER-01-002)

Aer Therapeutics

Status and phase: Not yet enrolling; Phase 2

Conditions: COPD

Treatments: Drug: Placebo; Drug: Flexlamose

Study type: Interventional

Funder types: Industry

Identifiers

NCT06731959

AER-01-002

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria

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.

Main Exclusion Criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Fexlamose

Experimental group

Description:

Fexlamose solution once daily via nebulizer for 28 days

Treatment:

Drug: Flexlamose

Placebo

Placebo Comparator group

Description:

Placebo solution once daily via nebulizer for 28 days

Treatment:

Drug: Placebo