RecruitingPhase 2

To Evaluate the Effect of EXPD-101/FXS7553 Compared With Placebo in Patients With COPD Over 52 Weeks of Treatment

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 52 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Study participants will be randomized to receive either study drug or placebo administered once daily for 52 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests two doses of EXPD-101 in people with COPD, a long-term lung disease, and chronic bronchitis, a lasting cough with mucus. It checks how well the drug works, its safety, and how the body handles it. Participants are assigned by chance to take the study drug or a placebo (no active drug) once a day for 52 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Give written consent to join the study.
  • Have a BMI (a measure of weight compared with height) from 18.5 to under 35. Men must weigh at least 50 kg and women at least 45 kg.
  • Have had COPD for at least 1 year, with doctor-confirmed chronic bronchitis and a cough with mucus for at least 3 months in the past year.
  • Have had at least 2 moderate or at least 2 severe COPD flare-ups in the past 12 months.
  • Smoke now or have smoked before, with at least 10 pack-years of smoking. This equals 1 pack a day for 10 years.
  • Have used a stable combination of 2 or 3 approved types of inhaled COPD medicines for at least 3 months.
  • Meet breathing test limits after medicine that opens the airways: FEV1/FVC below 0.7 and FEV1 at least 40% of the expected value. Have a COPD symptom score of at least 10.
  • Follow the study's birth control rules through 14 days after the last dose. People who can become pregnant must use highly effective birth control and not donate eggs. Men must follow rules about avoiding pregnancy and not donating sperm.

Who can't join

  • Have had a COPD flare-up in the past 4 weeks; pneumonia needing antibiotics or antiviral drugs within 28 days before the first visit; or another significant infection needing these drugs within 14 days.
  • Have another important lung disease, a serious weakness in the immune system, positive hepatitis B or C tests, known HIV infection, or active liver disease.
  • Have certain abnormal heart rhythm test results, other exam or test findings that could make the study unsafe or affect results, or an allergy to a study drug ingredient.
  • Have current or past-year alcohol or drug abuse. A cancer history may also exclude you, unless treatment to cure it ended at least 12 months ago for certain skin or early cervical cancers, or 5 years ago for other cancers.
  • Use biologic medicines for COPD now or have used them too recently; use oxygen for more than 12 hours a day; or received blood products, immune proteins, or a live weakened vaccine within 30 days before screening.
  • Started a lung rehabilitation program less than 4 weeks before screening. People in the program's maintenance phase may join.
  • Have or have had conditions linked to non-inherited thickening of the skin on the palms and soles.
  • Have a tooth that may cause pain or infection unless fixed before the study, active gum disease being treated or needing planned procedures during the study, or a planned tooth removal during the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Provided written informed consent for the study 2. Body mass index (BMI) ≥ 18.5 kg/m2 and \< 35 kg/m2 at screening (weight ≥ 50 kg for males and ≥ 45 kg for females) 3. Diagnosis of COPD for at least 1 year 4. COPD with physician-confirmed diagnosis of chronic bronchitis (persistent, productive cough and sputum for at least 3 months in the past year) 5. At least 2 moderate or \> 1 severe exacerbation within 12 months prior to screening 6. Current or ex-tobacco smokers with history of ≥ 10 pack-years (1 pack year = 20 cigarettes smoked per day for 1 year); 7. Stable maintenance therapy with either dual or triple inhaled therapy for ≥ 3 months prior to enrollment per below: 1. Dual therapy: long-acting beta-2 agonist/muscarinic antagonist (LABA/LAMA) or inhaled corticosteroids (ICS)/LAMA, or ICS/LABA OR 2. Triple therapy: ICS/LAMA/LABA 8. Post-BD FEV1/FVC \< 0.7 and post-BD FEV1(% predicted) ≥ 40% at Screening 9. COPD Assessment Test (CAT) score ≥ 10 at Screening 10. 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. 11. Male participants commit to the following during the study and for at least 14 days after the last dose: 1. Practice true sexual abstinence (refrain from heterosexual intercourse) 2. 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). 3. Be vasectomized (≥ 3 months prior to screening) 4. Refrain from donating sperm during the Treatment Period and for at least 14 days after the last dose of the IP Exclusion Criteria: 1. COPD exacerbation within the 4 weeks prior to randomization. 2. 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). 3. Significant immunodeficiency and/or positive serological tests for hepatitis B, hepatitis C, or known human immunodeficiency virus (HIV) infection. 4. Pneumonia requiring antibiotics or antiviral medication within 28 days prior to Visit 1. 5. 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. 6. Evidence of active liver disease (with or without ongoing treatment) 7. 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). 8. Current or history, within the past year of Visit 1, of substance and/or alcohol abuse. 9. History of cancer except: 1. 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 2. Participants who have had other malignancies are eligible provided that curative therapy was completed at least 5 years prior to Visit 1 10. 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. 11. Known history of allergy or reaction to any component of the investigational product formulation 12. 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 13. Current long-term treatment with oxygen therapy \> 12 hours per day 14. Use of immunoglobulin or blood products in 30 days prior to Screening 15. Received a live attenuated vaccine within 30 days prior to Screening 16. 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). 17. History or active conditions associated with the onset of non-hereditary palmoplantar keratosis: 18. Have any tooth that can potentially cause pain or infection as noted in the oral exam unless they are corrected before the study 19. Has active periodontal disease and are either: 1. Currently treated by a dentist for this condition or 2. Expected to have periodontal disease-related procedures within the study period 20. Are scheduled to have tooth extraction that will occur during the study period

Study sites (22)

AZ

CA

CO

FL

GA

IN

KS

MN

NC

OH

PA

SC

TX

VA