Can a new biologic drug prevent COPD Flare-Ups?
NCT ID NCT07725939
First seen Jul 24, 2026 · Last updated Aug 28, 2026 · Updated 8 times
Summary
This phase 2 trial tests whether galvokimig, an experimental biologic drug, can reduce the number of moderate-to-severe COPD flare-ups in people with chronic bronchitis. About 400 adults aged 40 to 80 with moderate-to-severe COPD will receive either galvokimig or a placebo as an injection over 24 to 52 weeks. The main goal is to see if the drug delays the first serious flare-up compared to placebo.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental biologic drug called galvokimig
- What this could lead to
- If it works, galvokimig could offer a new way to prevent COPD flare-ups and slow lung decline in people with chronic bronchitis.
- What could go wrong
- This is an early phase 2 trial, so the drug may not prove effective or safe. Side effects from a biologic are possible, and results may not apply to all COPD patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 402 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion 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 * Participant has a documented record of receiving maintenance inhaled therapy at a stable dose for ≥3 months prior to Screening comprised of: • 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 Screening or 1 severe AECOPD in the 6 months prior to Screening * 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 * A female participant is eligible to participate if she is not pregnant not breastfeeding, and at least one of the following conditions applies: * 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) Exclusion criteria: * 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 constitute a risk when taking the study intervention; or interfere with the interpretation of data and could jeopardize or would compromise the study participant's ability to participate in this study * 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, within 12 months prior to Screening * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Copd01 20001
RECRUITINGBeijing, China
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Copd01 50001
RECRUITINGBoerne, Texas, 78006, United States
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Copd01 50002
RECRUITINGDuBois, Pennsylvania, 15801, United States
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Copd01 50003
RECRUITINGColumbus, Ohio, 43215, United States