Chronic Obstructive Pulmonary Disease With Chronic Bronchitis study: Galvokimig
Official title A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Study Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD) With Chronic Bronchitis
ClinicalTrials.gov ID: NCT07725939
What this study is testing
What is Galvokimig?
An investigational injectable medicine being studied as a potential treatment for chronic obstructive pulmonary disease with chronic bronchitis.
Also referred to as UCB9741.
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
- The study aims to find out whether galvokimig can lengthen the time before the first acute COPD exacerbation compared with a placebo.
- Who it's for
- Adults who have moderate‑to‑severe chronic obstructive pulmonary disease with chronic bronchitis.
- What's involved
- Participants will be randomly given either galvokimig or a placebo and will attend scheduled clinic visits for dosing and safety checks.
- Time commitment
- The trial lasts 24 to 52 weeks, with regular visits throughout the treatment period.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
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 80
You may be able to join if
- Participant must be aged ≥40 to ≤80 years of age, inclusive, at the time of signing the Informed Consent form (ICF)
- Participant with a documented physician-diagnosed moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) with chronic bronchitis phenotype
- long-acting beta2 agonist (LABA) +long-acting muscarinic antagonist (LAMA) ±inhaled corticosteroid (ICS)
- Participant at a high risk of exacerbations, defined as a documented exacerbation history of ≥2 moderate or severe acute exacerbation(s) of chronic...
- Participant has a Chronic Airways Assessment Test (CAAT) score of ≥15 at Screening
You likely can't join if
- Participant has any history or presence of any medical or psychiatric condition, physical examination finding, laboratory test result, or...
- Participant has a history of uncompensated heart failure, fluid overload, or myocardial infarction, or evidence of new onset ischemic heart disease...
- Participant has a presence or a family history (first degree) of inflammatory bowel disease (IBD)
- Participant has uncontrolled neuropsychiatric disorder, active suicidal ideation, or positive suicidal behavior
- Participant has a history of chronic or recurrent clinically significant infections, or a serious extrapulmonary infection within the 6 months prior...
- Participant has clinically important pulmonary disease other than COPD with chronic bronchitis
See the full eligibility criteria
- Participant must be aged ≥40 to ≤80 years of age, inclusive, at the time of signing the Informed Consent form (ICF)
- Participant with a documented physician-diagnosed moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) with chronic bronchitis phenotype
- long-acting beta2 agonist (LABA) +long-acting muscarinic antagonist (LAMA) ±inhaled corticosteroid (ICS)
- Participant at a high risk of exacerbations, defined as a documented exacerbation history of ≥2 moderate or severe acute exacerbation(s) of chronic obstructive pulmonary disease (AECOPD) in the 12 months prior to...
- Participant has a Chronic Airways Assessment Test (CAAT) score of ≥15 at Screening
- Participant has acceptable inhaler and spirometry techniques according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines during the Screening Visit
- Participant can be male or female.
- A male participant must agree to use contraception during the Intervention Periods and for at least 60 days after the final dose of study intervention and refrain from donating sperm during this period
- Not a women of childbearing potential (WOCBP) OR
- A WOCBP who agrees to follow the contraceptive guidance during the Intervention Periods and for at least 60 days after the final dose of study intervention
- Participant is a current or ex-smoker (with tobacco smoking history of ≥10 pack-years)
- Participant has any history or presence of any medical or psychiatric condition, physical examination finding, laboratory test result, or electrocardiogram (ECG) signal that, in the opinion of the investigator, could...
- Participant has a history of uncompensated heart failure, fluid overload, or myocardial infarction, or evidence of new onset ischemic heart disease or in the opinion of the investigator other serious cardiac disease...
- Participant has a presence or a family history (first degree) of inflammatory bowel disease (IBD)
- Participant has uncontrolled neuropsychiatric disorder, active suicidal ideation, or positive suicidal behavior
- Participant has a history of chronic or recurrent clinically significant infections, or a serious extrapulmonary infection within the 6 months prior to Baseline
- Participant has clinically important pulmonary disease other than COPD with chronic bronchitis
- Participant has hypercapnia requiring bilevel positive airway pressure (BiPAP)
- Participant has had a live or attenuated vaccines within 4 weeks prior to Screening or plans to receive such vaccines during the study
- Participant has relevant safety events to one or more interleukin (IL)-13 or IL-17 biologic response modifiers that resulted in discontinuation and change of treatment
- Participant has absolute neutrophil count (ANC) \<1.5 × 10³/μL
- Participant has a corrected QT interval (QTc) \>450msec for male participants or QTc \>470msec for female participants or QTc \>480 msec in participants with bundle branch block
- Participant has a history of past or current chronic alcohol or drug abuse within the previous 12 months
The study team makes the final eligibility decision.
Where it is enrolling
- Encino, California, United States
- Westminster, California, United States
- Miami, Florida, United States
- Rincon, Georgia, United States
- Charlotte, North Carolina, United States
- Columbus, Ohio, United States
- Medford, Oregon, United States
- DuBois, Pennsylvania, United States
- North Charleston, South Carolina, United States
- Rock Hill, South Carolina, United States
- Spartanburg, South Carolina, United States
- Union, South Carolina, United States
- Boerne, Texas, United States
- McKinney, Texas, United States
- Tomball, Texas, United States
- Seattle, Washington, United States
- Beijing, China
- Chengdu, China
- Guangzhou, China
- Hangzhou, China
+ 5 more site(s).
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
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, but 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 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Encino, California, United States; Westminster, California, United States; Miami, Florida, United States; Rincon, Georgia, United States; Charlotte, North Carolina, United States; Columbus, Ohio, United States and 19 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.