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Compares treatment options for Chronic Obstructive Pulmonary Disease (COPD)
Official title To Evaluate the Effect of EXPD-101/FXS7553 Compared With Placebo in Patients With COPD Over 52 Weeks of Treatment
ClinicalTrials.gov ID: NCT07684820
What this study is testing
What is EXPD-101/FXS7553 Dose 1?
EXPD-101/FXS7553 Dose 1 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic obstructive pulmonary disease (copd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 85
You may be able to join if
- 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
You likely can't join if
- 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...
- 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...
- Evidence of active liver disease (with or without ongoing treatment)
See the full eligibility criteria
- 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);
- 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...
- 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
- 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...
- 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)
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Northridge, California, United States
- Aurora, Colorado, United States
- Leesburg, Florida, United States
- Miami, Florida, United States
- Orange, Florida, United States
- Rincon, Georgia, United States
- Indianapolis, Indiana, United States
- Topeka, Kansas, United States
- Philadelphia, Pennsylvania, United States
- Tomball, Texas, United States
- Burke, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Northridge, California, United States; Aurora, Colorado, United States; Leesburg, Florida, United States; Miami, Florida, United States; Orange, Florida, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.