Chronic Obstructive Pulmonary Disease (COPD)Phase 2NavigatorNCT07684820
To Evaluate the Effect of EXPD-101/FXS7553 Compared With Placebo in Patients With COPD Over 52 Weeks of Treatment
A Phase 2 study testing EXPD-101/FXS7553 Dose 1 and EXPD-101/FXS7553 Dose 2 in people with Chronic Obstructive Pulmonary Disease (COPD), run by Expedition Therapeutics, Inc at 22 sites in United States.
Trial summary
This is a Phase 2 study of the efficacy, safety, tolerability and pharmacokinetics of two doses of EXPD-101 in participants with COPD. Study participants will be randomized to receive either study drug or placebo administered once daily for 52 weeks. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- EXPD-101/FXS7553 Dose 1 and EXPD-101/FXS7553 Dose 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 22 sitesUnited States
- Study dates
- 30 Jun 2026to 11 Jul 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provided written informed consent for the study
- Body mass index (BMI) ≥ 18.5 kg/m2 and < 35 kg/m2 at screening (weight ≥ 50 kg for males and ≥ 45 kg for females)
- Diagnosis of COPD for at least 1 year
- COPD with physician-confirmed diagnosis of chronic bronchitis (persistent, productive cough and sputum for at least 3 months in the past year)
- At least 2 moderate or > 1 severe exacerbation within 12 months prior to screening
- Current or ex-tobacco smokers with history of ≥ 10 pack-years (1 pack year = 20 cigarettes smoked per day for 1 year);
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- Stable maintenance therapy with either dual or triple inhaled therapy for ≥ 3 months prior to enrollment per below:
- Dual therapy: long-acting beta-2 agonist/muscarinic antagonist (LABA/LAMA) or inhaled corticosteroids (ICS)/LAMA, or ICS/LABA OR
- Triple therapy: ICS/LAMA/LABA
- Post-BD FEV1/FVC < 0.7 and post-BD FEV1(% predicted) ≥ 40% at Screening
- COPD Assessment Test (CAT) score ≥ 10 at Screening
- If participant is of childbearing potential, must commit to practicing highly effective methods of birth control and not donating eggs during the study and at least 14 days after the last dose.
- Male participants commit to the following during the study and for at least 14 days after the last dose:
- Practice true sexual abstinence (refrain from heterosexual intercourse)
- Use a condom with any female partner of childbearing potential and ensure that the partner uses a highly effective contraceptive method (eg, IUD/IUS, combined hormonal contraception, progestogen-only contraception, or bilateral tubal occlusion).
- Be vasectomized (≥ 3 months prior to screening)
- Refrain from donating sperm during the Treatment Period and for at least 14 days after the last dose of the IP
Who cannot join
- COPD exacerbation within the 4 weeks prior to randomization.
- Clinically important pulmonary disease other than COPD (eg, asthma, active lung infection, clinically significant bronchiectasis, pulmonary fibrosis, cystic fibrosis, lung cancer, alpha-1 antitrypsin deficiency, tuberculosis).
- Significant immunodeficiency and/or positive serological tests for hepatitis B, hepatitis C, or known human immunodeficiency virus (HIV) infection.
- Pneumonia requiring antibiotics or antiviral medication within 28 days prior to Visit 1.
- History of clinically significant infection (excluding pneumonia), acute upper or lower respiratory infection, requiring antibiotics or antiviral medication within 14 days prior to Visit 1.
- Evidence of active liver disease (with or without ongoing treatment)
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- Participants with a QT interval, from the ECG conducted at Screening Visit 1, corrected with Fridericia's formula (QTcF) > 450 msec (or QTcF > 480 msec in participants with bundle branch block).
- Current or history, within the past year of Visit 1, of substance and/or alcohol abuse.
- History of cancer except:
- Participants who have had basal cell carcinoma, localized squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible to participate in the study provided that curative therapy was completed at least 12 months prior to Visit 1
- Participants who have had other malignancies are eligible provided that curative therapy was completed at least 5 years prior to Visit 1
- Any clinically significant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis during Screening Period, which in the opinion of the investigator, may put the participant at risk because of his/her participation in the study, or may influence the results of the study, or the participant's ability to complete the entire duration of the study.
- Known history of allergy or reaction to any component of the investigational product formulation
- Current treatment with biologic drugs for COPD (eg, dupilumab, mepolizumab) or use of Therapeutics, biologics within 5 half-lives or 4 months, whichever is longer, from randomization
- Current long-term treatment with oxygen therapy > 12 hours per day
- Use of immunoglobulin or blood products in 30 days prior to Screening
- Received a live attenuated vaccine within 30 days prior to Screening
- Participants who are participating in the acute phase of a pulmonary rehabilitation program, i.e. who started rehabilitation < 4 weeks prior to screening (Note: participants in the maintenance phase of a rehabilitation program can be included).
- History or active conditions associated with the onset of non-hereditary palmoplantar keratosis:
- Have any tooth that can potentially cause pain or infection as noted in the oral exam unless they are corrected before the study
- Has active periodontal disease and are either:
- Currently treated by a dentist for this condition or
- Expected to have periodontal disease-related procedures within the study period
- Are scheduled to have tooth extraction that will occur during the study period
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
United States22 sites, 22 recruiting
- Recruiting
International Clinical Research
Altamonte Springs, Florida, 32701
Patrica Martinez, 407-878-5830, pmartinez@icresearch.net
Andrew Feldman
- Recruiting
Lynn Institute of Denver
Aurora, Colorado, 80012
Jessica Kovarna, 303-322-0397, jmoore@lhsi.net
Timothy Colander
- Recruiting
Burke Internal Medicine, Inc.
Burke, Virginia, 22015
Amy Aziz, 7034559711, amy@burkeclinicaltrials.com
Nashwa Gabra
- Recruiting
Remington-Davis Research
Columbus, Ohio, 43215
Ayriah Storms, 6146853426, ayriah.storms@osumc.edu
Cordasco
- Recruiting
Nature Coast Clinical Research
Crystal River, Florida, 34229
Donna Robinson, 352-563-1865, drobinson@flourishresearch.com
Ranganantha Potu
- Recruiting
Horizon Clinical Research Group.
Cypress, Texas, 77429
Lucia Sabido, 2818415798, lsabido@horizoncrg.com
Dileep Puppala
- Recruiting
Clinical Research Associates of Central PA, LLC
DuBois, Pennsylvania, 15801
Mark Capichana, 814 940-1212, mark@clinicalresearchassoc.com
Sandeep Bansal
- Recruiting
DM Clinical Research-Indianapolis
Indianapolis, Indiana, 46254
Stephanie Samayoa, 4632713179, stephanie.samayoa@dmclinical.com
Brandon Essink
- Recruiting
Clinical Site Partners, LLC Leesburg dba Flourish Research
Leesburg, Florida, 34748
Crystal Howell, 888-688-8277, chowell@flourishresearch.com
Jose Diaz
- Recruiting
Headlands Research Twin Cities
Maplewood, Minnesota, 55109
Kristina Smith, 651-797-6886, kristina.smith@headlandsresearch.com
Charlene McEvoy
- Recruiting
Metroplex Pulmonary and Sleep Center
McKinney, Texas, 75069
Rupa Krishna, 972-838-1892, rkrishna@mpsleepcenter.com
Shahrukh Kureishy
- Recruiting
Suncoast Research Group, LLC Miami - Little Havana dba Flourish Research
Miami, Florida, 33135
Jaymie Marquez, 3052557452, jmarquez@flourishresearch.com
Mark Kutner
- Recruiting
California Medical Research Associates Inc.
Northridge, California, 91324
Chrismarie Goonarathne, 8183491979, chrismarie.cmra@gmail.com
Jigar Kadakia
- Recruiting
Optimal Research Sites
Orange, Florida, 32763
Janyssa Balmes, 3862185911, jbalmes@optimalresearchsites.net
Kristyna Paradis
- Recruiting
DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania, 19107
Michael Coyle, 4453009011, michael.coyle@dmclinical.com
David Wheeler
- Recruiting
DM Clinical Research - Phoenix
Phoenix, Arizona, 85012
Jade Perez, 6232320800, jade.perez@dmclinical.com
Danielle Armas
- Recruiting
Centricity Research Columbus
Rincon, Georgia, 31326
Ashley King, 8437255067308, aking@clinicaltrialssc.com
Maria Mascolo
- Recruiting
Clinical Research of Rock Hill
Rock Hill, South Carolina, 29732
Lacie Thomas, 803-251-9502, lthomas@cresrh.com
Michael Denenberg
- Recruiting
Carolina Research Center, Inc.
Shelby, North Carolina, 28150
Aimee Scronce, 704-600-6052, aimeescroncecrc@yahoo.com
Stephen Jones
- Recruiting
DM Clinical Research- Tomball
Tomball, Texas, 77375
Maryam Jamil, 2815170550, maryam.jamil@dmclinical.com
Mustafa Naeem
- Recruiting
Cotton O'Neil Clinical Research Center
Topeka, Kansas, 66606
Ambrosee Wilkinson, 7853680741, ambrosee.wilkinson@stormontvail.org
Najm Salah
- Recruiting
Tidewater Clinical Research
Virginia Beach, Virginia, 23456
April Rusch, 7574713375, april.rusch@tidewaterclinresearch.com
Marc Gaines
About this study
Official title: A Randomized, Double-Blind, Placebo-controlled, Parallel Arm, 52-week Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of Two Doses of EXPD-101 in Participants With COPD
This is a Phase 2 study of the efficacy, safety, tolerability and pharmacokinetics of two doses of EXPD-101 in participants with COPD. Study participants will be randomized to receive either study drug or placebo administered once daily for 52 weeks.
- Being tested
- EXPD-101/FXS7553 Dose 1, EXPD-101/FXS7553 Dose 2, Placebo
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Bronchitis, DPP, DPP1, DPP Inhibitor, DPP1 Inhibitor
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXPD-101/FXS7553 Dose 1Drug
Oral tablet
EXPD-101/FXS7553 Dose 2Drug
Oral tablet
PlaceboDrug
EXPD-101/FXS7553 - matching oral tablet.
| Study group | Role | What they receive |
|---|---|---|
| EXPD-101/FXS7553 Dose 1 | Experimental | Participants will receive EXPD-101/FXS7553 Dose 1, orally, once daily, for 52 weeks. Receives: Drug: EXPD-101/FXS7553 Dose 1 |
| EXPD-101/FXS7553 Dose 2 | Experimental | Participants will receive EXPD-101/FXS7553 Dose 2, orally, once daily, for 52 weeks. Receives: Drug: EXPD-101/FXS7553 Dose 2 |
| Placebo | Placebo comparator | Participants will receive a EXPD-101/FXS7553-matching placebo, tablets orally, once daily, for 52 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized rate of moderate and severe COPD exacerbations
Effect of EXPD-101/FXS7553 compared with placebo on rate of moderate and severe COPD exacerbations.
Moderate COPD exacerbation is defined as acute exacerbations of COPD that require either systemic corticosteroids (intramuscular (IM), intravenous, or oral) and/or antibiotics.
Severe COPD exacerbation is defined as acute exacerbation of COPD requiring hospitalization or emergency room / urgent care visit ≥ 24 hours.
Measured: Over 52 Weeks
The number of participants experiencing an adverse events (AEs)
The number of participants experiencing an AE (an AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship) will be presented.
Measured: Over 52 weeks
Changes in vital sign parameters
Vital signs, including systolic and diastolic BP (mmHg), heart rate (beats per minute), body temperature (°C), and respiratory rate will be listed and summarized.
Measured: Over 52 weeks
Changes in electrocardiogram (ECG) parameters
ECG (graphical tracing that records the electrical signals of your heartbeat) parameters will be summarized.
Measured: Over 52 weeks
Number of Participants with Clinically Significant Changes in Physical Examination Findings
Physical examination will be performed at each study visit by a qualified investigator. The following body systems will be assessed: ears, nose, throat, skin, cardiovascular, respiratory, musculoskeletal, and neurological.
Measured: Over 52 weeks
Number of participants with clinically significant abnormalities
Clinical laboratory assessments including hematology, serum chemistry, and urinalysis will be performed at each study visit.
Measured: Over 52 weeks
Changes in Physical Exam Parameters - Body Weight
Body weight measured using a calibrated scale at each study visit
Measured: Over 52 weeks
Secondary outcomes (8)
Time to first moderate or severe COPD exacerbation
Effect of EXPD-101/FXS7553 compared with placebo on time to first moderate or severe COPD exacerbation.
Measured: Over 52 Weeks
Change From Baseline in Quality of Life Questionnaire - St. George's Respiratory Questionnaire (SGRQ)
The SGRQ is a validated, self-administered patient-reported outcome (PRO) that assesses symptoms, functioning, and health-related quality of life for participants with Chronic Obstructive Pulmonary Disease (COPD).
It contains 50 items in 2 parts. Part 1 has 8 items for assessing the severity of respiratory symptoms (cough, sputum production, wheeze, breathlessness, and the duration and frequency of attacks of breathlessness or wheeze). Part 2 has 42 items across 2 components (Activity and Impacts) related to daily activities and psychosocial impacts of the participant's respiratory condition. The SGRQ total score is calculated as the sum of scores across symptoms, activity, and effects, with 0 indicating the best possible health status and 100 indicating the worst possible health status. A decrease in 4 units in the total score corresponds to a clinically significant improvement in the quality of life.
Measured: Baseline, Week 52
Change From Baseline at Week 52 in Postbronchodilator Forced Expiratory Volume in 1 Second (FEV1) and forced vital capacity (FVC)
FEV1 is used to assess lung function and is the maximum amount of air that can be forced out in one second after first second after taking a forced expiration as measured by a spirometer. Postbronchodilator FEV1 tests included spirometry tests performed after administration of bronchodilator.
FVC is used to assess lung function and is the total volume of air that can be forced out after taking a deep breath as measured by a spirometer.
Measured: Baseline, Week 52
Change From Baseline at Week 52 in Quality of Life Questionnaire - Evaluating Respiratory Symptoms (E-RS): COPD
The E-RS:COPD™ scale, a part of the EXACT tool, is a derivative instrument used to measure the effect of treatment on the severity of respiratory symptoms in stable COPD. The E-RS is an 11-item participant-reported diary to measure respiratory symptom items contained in the 14-item EXACT.
Summation of E-RS: COPD item responses produces a total score ranging from 0 to 40, with higher scores indicating greater severity. In addition to the total score, symptom domain scores can be calculated for breathlessness (5 items; score range: 0-17), cough and sputum (3 items; score range: 0-11) and chest symptoms (3 items; score range: 0-12) by summing the responses of items within a respective domain. As with the total score, higher domain scores indicate greater severity.
Measured: Baseline, Week 52
Annualized rate of severe COPD exacerbations
Effect of EXPD-101/FXS7553 compared with placebo on rate of severe COPD exacerbations.
Measured: Over 52 Weeks
Plasma Concentration and metabolites of EXPD-101/FXS755
Measured: Pre-dose at baseline, and Weeks 2, 4, 12, 28, 52 and 56.
Change from Baseline in sputum neutrophil elastase (NE) activity
Effect of EXPD-101/FXS7553 compared with placebo on sputum neutrophil elastase (NE) activity.
Measured: Over 52 Weeks
Annualized rate of COPD exacerbations requiring Emergency Department visit and/or hospitalization
Effect of EXPD-101/FXS7553 compared with placebo on rate of COPD exacerbations requiring Emergency Department visit and/or hospitalization.
Measured: Over 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start30 Jun 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion11 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Expedition Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Duncan Chalmers, MBChB, PhD, Study chair, Radcliffe Department of Medicine, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684820
- Sponsor's protocol ID
- EXPD-101-201
- Other IDs
- 2026-525216-34
- Acronym
- Navigator
- Status last verified
- Sep 2026
- First submitted
- 6 May 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared externally. Data collected in this study will be used solely for internal analysis and regulatory submission purposes, consistent with participant confidentiality protections and sponsor data governance policies.