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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Aer Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

4 Mar 2026 → ongoing

Decision date (initial)

2026-01-19

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Aer Therapeutics, Inc.

External identifiers

EU CT number

2025-523020-50-00

ClinicalTrials.gov

NCT06731959

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety, Efficacy, Others

To evaluate the efficacy of AER-01 compared with placebo

Secondary objectives 1

1. To assess the efficacy of AER-01 compared with placebo

Conditions and MedDRA coding

Chronic Obstructive Pulmonary Disease

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. 1. The study will enroll participants with a diagnosis of COPD. Each participant must meet all the following criteria to be enrolled in this study: • Is male or female ≥40 to ≤80 years of age.
2. 2. Has a verified diagnosis of cigarette smoking-related COPD demonstrated by both of the following: o Is a current or former smoker with a history of ≥10 pack years of cigarette smoking. o Has a postbronchodilator FEV1/FVC ratio <0.70.
3. 3. Has moderate to severe COPD defined in this study as a prebronchodilator FEV1 that is >25% and <60% of predicted normal at Visit 1.
4. 4. Participant meets the following spirometry performance criteria: o Acceptability: Participant can perform acceptable spirometry (ie, meet ATS/ERS acceptability criteria) at Visits 1 and 2. o Repeatability: Participant can perform technically acceptable spirometry meeting repeatability criteria for FEV1 during ≥1 of the prebronchodilator assessments at Visits 1 and 2. o Participant’s baseline (predose) FEV1 at Visit 3 must be within the greater of 12% or 100 mL of the mean FEV1 obtained at the 2 Screening visits.
5. 5. Participant has a whole lung emphysema percent <40% based on automated analysis of the CT lung scan
6. 6. Participant is on stable maintenance inhaler medications for COPD with no dose adjustments for ≥4 weeks prior to Screening and during the Screening Period.
7. 7. Participant has maintenance medications, including an inhaled bronchodilator (short- or long acting beta adrenergic agonist or short- or long acting muscarinic antagonist).
8. 8. Participant has had ≤2 COPD exacerbations requiring hospitalization in the past year.

Exclusion criteria 15

1. 1. Participants meeting any of the following criteria will be excluded from the study: • Participant has an active uncontrolled medical condition that, in the opinion of the investigator or medical monitor, might obfuscate the study data. Examples of such medical conditions that, if uncontrolled at Visit 1, would be exclusionary include: hypertension, diabetes, renal failure, coronary artery disease, cardiac failure, gastro esophageal reflux disease, cancer, alcohol use disorder, illicit drug use, or psychiatric disease.
2. 2. Participant has primary diagnosis of non-CF bronchiectasis, primary ciliary dyskinesia, allergic bronchopulmonary aspergillosis, or CF.
3. 3. Participant has a finding on their screening CT lung scan of varicose or cystic bronchiectasis affecting >1 lobe or of cylindrical bronchiectasis affecting >2 lobes.
4. 4. Participant has a finding on their screening CT lung scan of "tree in bud" opacities (indicative of small airway inflammation/infection).
5. 5. Participant has a lung nodule discovered on their screening CT lung scan that, in the opinion of the site investigator, requires a timely work-up that would be adversely affected by participation in the study. In making this assessment, the site investigator should consider the size and appearance of the nodule and the guidance provided by the Fleischner Society.
6. 6. Participant has had a COPD exacerbation in the 6 weeks prior to Visit 1 (Screening) or during the Screening Period (Visit 1 to Visit 3).
7. 7. Participant has had a viral respiratory tract infection (including coronavirus) in the 4 weeks prior to Screening.
8. 8. Participant is currently using any vaping product or has used a vaping product within 1 week of signing the informed consent.
9. 9. Participant is currently smoking cannabis or has smoked cannabis within 1 week of signing the informed consent.
10. 10. Participant has active lung infection with nontuberculous mycobacteria, Pseudomonas aeruginosa, or Staphylococcus aureus.
11. 11. Participant has received any vaccine within 7 days prior to Day 1.
12. 12. Participant is using dupilumab or tezepelumab for control of COPD, or any medical condition. Note: Patients who are taking benralizumab, mepolizumab, or omalizumab at a stable dose for ≥6 months are not excluded.
13. 13. Participant has a hypersensitivity to fexlamose or to any of the excipients or placebo components.
14. 14. Participant has active or latent pulmonary tuberculosis.
15. 15. Participant has moderate or severe abnormalities in liver or renal function tests at Screening (ie, Grade >2 abnormalities).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. • Change from baseline in prebronchodilator FEV1 at Week 4

Secondary endpoints 9

1. 1. Change from baseline in CT MPSS at w 4
2. 2. Percentage of participants who have treatment related reduction of MPSS
3. 3. Change from baseline in SGRQ-C at w 4
4. 4. Percentage of participants with ≥4 unit decrease from baseline in SGRQ-C at w 4
5. 5. Change from baseline in prebronchodilator FVC at w 4
6. 6. Change from baseline in SpO2 at w 4
7. 7. Incidence of AEs throughout the study
8. 8. Hematology, biochemistry, and urinalysis parameters assessed throughout the study
9. 9. Incidence of GGO as detected by CT lung scan at w 4

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Aer Therapeutics Inc.

Sponsor organisation

Aer Therapeutics Inc.

Address

8 Davis Drive

City

Durham

Postcode

27709-0003

Country

United States

Scientific contact point

Organisation

Aer Therapeutics Inc.

Contact name

Jordan Low

Public contact point

Organisation

Aer Therapeutics Inc.

Contact name

Jordan Low

Third parties 5

Locations

3 EU/EEA countries · 14 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 46 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications