Can a new biologic drug delay dangerous lung Flare-Ups?
NCT ID NCT07720375
First seen Jul 22, 2026 · Last updated Aug 12, 2026 · Updated 4 times
Summary
This phase 2 trial is testing whether an experimental biologic drug called galvokimig can delay the first moderate or severe lung infection (pulmonary exacerbation) in adults with non-cystic fibrosis bronchiectasis, a chronic lung condition that causes coughing, mucus buildup, and frequent infections. About 300 participants will receive either galvokimig or a placebo by injection for up to 52 weeks. The study aims to see if the drug reduces the need for antibiotics or hospital stays.
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 successful, galvokimig could become a new treatment option to reduce serious lung infections in people with non-cystic fibrosis bronchiectasis.
- 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 injection are possible.
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 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Apr 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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18 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 18 to ≤80 years of age, inclusive, at the time of signing the informed consent form (ICF) * Participant with a documented history of Non-Cystic Fibrosis Bronchiectasis (NCFB) (cough, chronic sputum production, and/or recurrent respiratory infections) confirmed by high resolution computed tomography (HRCT) demonstrating bronchiectasis in 1 or more lobes. Confirmation of diagnosis via HRCT will be performed as close as possible to, and within 7 calendar days of the Baseline visit, in all participants who meet all inclusion criteria and no exclusion criteria at Screening. Central reading confirmation, where images are evaluated by independent centralized experts, is required before the participant is randomized * Participant with a history of chronic expectoration who are current sputum producers and are able to provide spontaneous sputum sample at Screening. If the participant is unable to produce spontaneous sputum at Screening, the participant will be considered a screening failure and may be rescreened once * Participant with a history of at least 2 moderate or severe pulmonary exacerbations within the past 12 months prior to Screening or 1 severe pulmonary exacerbation within 6 months prior to Screening * Participant with post- Bronchodilator (BD) forced expiratory volume (FEV) 1% predicted ≥30% at Screening and Baseline * Participant has acceptable inhaler (where applicable) and spirometry techniques according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines during the Screening Visit. Participants who do not meet such criteria can be repeated once without being rescreened * Participant can be male or female * A male participant must agree to use contraception during the Intervention Period 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 (including pumping breastmilk to feed a child), and at least 1 of the following conditions applies: * Not a woman of childbearing potential (WOCBP) OR * A WOCBP who agrees to follow the contraceptive guidance during the Intervention Period and for at least 60 days after the final dose of study intervention 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 presence or family history (first degree) of inflammatory bowel disease (IBD) (includes Crohn's disease and ulcerative colitis) * Participant has a history of chronic or recurrent clinically significant infections, or a serious extrapulmonary infection within 6 months prior to the Baseline, as judged by the investigator. * Participant is not permitted to enroll into the study if they meet any of the following Tuberculosis (TB) exclusion criteria: * Known active TB disease. * History of active TB involving any organ system unless adequately treated according to World Health Organization/Centers for Disease Control and Prevention therapeutic guidance and proven to be fully recovered upon consultation with an appropriate relevant specialist * Latent tuberculosis infection (LTBI) (unless a course of appropriate preventative therapy has been completed prior to study intervention dosing). TB preventive therapy should be in accordance with applicable clinical guidelines and appropriate specialist judgment based on the origin of the infection * High risk of acquiring TB infection * Participant has clinically important pulmonary disease other than NCFB as judged by the investigator. * Participant has an acute infection (including pulmonary infection) requiring antibiotics, systemic corticosteroids, or antiviral medication within 4 weeks prior to Screening (and in the Screening Period) based on the final day of antibiotic/antiviral/systemic steroid treatment or hospitalization discharge date, whichever occurred later. A participant who suffers from a pulmonary exacerbation during the Screening Period, prior to randomization, is considered a screen failure. Rescreening is allowed once following resolution of the pulmonary exacerbation * Participant has bronchiectasis known to be due to lung fibrosis, cystic fibrosis, hypogammaglobulinemia, common variable immunodeficiency disorders or α1-antitrypsin deficiency * Participant has a primary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or asthma. A secondary diagnosis is allowed * Participant has significant hemoptysis defined as ≥300mL or requiring blood transfusion within 6 weeks from Screening * Participant has a history of lung transplantation * Study participant has an absolute neutrophil count (ANC) \<1.5×103/μL. This test can be repeated once
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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
3 sites. 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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Ncfb01 50001
RECRUITINGMcKinney, Texas, 75069, United States
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Ncfb01 50004
RECRUITINGDuBois, Pennsylvania, 15801, United States
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Ncfb01 50005
RECRUITINGPlantation, Florida, 33324-7006, United States
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