Non-cystic Fibrosis Bronchiectasis study: Galvokimig
Official title A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
ClinicalTrials.gov ID: NCT07720375
What this study is testing
What is Galvokimig?
An investigational injectable medicine being studied for non‑cystic fibrosis bronchiectasis.
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 wants to find out whether galvokimig can slow the time until the first pulmonary exacerbation compared with a placebo.
- Who it's for
- Adults who have non‑cystic fibrosis bronchiectasis.
- What's involved
- Participants will receive either galvokimig or a placebo and will have regular clinic visits and medical tests to monitor lung health and any side effects.
- Time commitment
- The study lasts between 24 and 52 weeks, with scheduled visits throughout that 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, 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 18 to 80
You may be able to join if
- 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...
You likely can't join if
- at Screening. Central reading confirmation, where images are evaluated by independent centralized experts, is required before the participant is...
- Participant with a history of chronic expectoration who are current sputum producers and are able to provide spontaneous sputum sample at Screening.
- Participant with a history of at least 2 moderate or severe pulmonary exacerbations within the past 12 months prior to Screening or 1 severe...
- 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...
- Participant can be male or female
See the full eligibility 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)...
- at Screening. Central reading confirmation, where images are evaluated by independent centralized experts, is required before the participant is assigned by chance
- Participant with a history of chronic expectoration who are current sputum producers and are able to provide spontaneous sputum sample at Screening.
- 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.
- 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
- Not a woman of childbearing potential (WOCBP) OR
- 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 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.
- 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...
- Latent tuberculosis infection (LTBI) (unless a course of appropriate preventative therapy has been completed prior to study intervention dosing).
- 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...
- 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) \<1.5×10\^3/μL. This test can be repeated once
The study team makes the final eligibility decision.
Where it is enrolling
- Newport Beach, California, United States
- Brandon, Florida, United States
- Plantation, Florida, United States
- DuBois, Pennsylvania, United States
- Rock Hill, South Carolina, United States
- McKinney, Texas, United States
- Mesquite, Texas, 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, 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, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Newport Beach, California, United States; Brandon, Florida, United States; Plantation, Florida, United States; DuBois, Pennsylvania, United States; Rock Hill, South Carolina, United States; McKinney, Texas, United States and 1 more location. 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.