Galvokimig for Bronchiectasis
(ATMOS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests galvokimig to determine if it can delay lung flare-ups in individuals with non-cystic fibrosis bronchiectasis, a condition causing persistent coughing and mucus. Participants will receive varying doses of galvokimig or a placebo (a pill with no medicine) to compare effects. It suits those who have experienced at least two significant lung flare-ups in the past year and currently produce mucus regularly. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important early-stage findings.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study tested Galvokimig on people with atopic dermatitis, a skin condition that causes itchy and inflamed skin. The safety results were consistent, with no unexpected problems reported, suggesting that Galvokimig was generally well-tolerated by participants. However, larger studies are needed to fully confirm its safety. Galvokimig is currently in an early testing phase, so information on its safety for treating non-cystic fibrosis bronchiectasis—a lung condition that causes a persistent cough and mucus production—remains limited.12345
Why do researchers think this study treatment might be promising for bronchiectasis?
Galvokimig is unique because it potentially offers a new approach to treating bronchiectasis, a condition often managed with antibiotics and airway clearance techniques. Unlike standard treatments, Galvokimig is designed to target the underlying inflammation in the airways more directly, which could reduce reliance on antibiotics and improve lung function. Researchers are particularly excited about its novel mechanism of action, which might offer better control over symptoms and fewer side effects compared to existing therapies.
What evidence suggests that galvokimig could be an effective treatment for non-cystic fibrosis bronchiectasis?
Studies have shown that galvokimig, a new antibody-based treatment, targets key proteins involved in inflammation, such as IL-13, IL-17A, and IL-17F. These proteins play a role in conditions like non-cystic fibrosis bronchiectasis (NCFB), which inflames the airways. Previous research on other conditions, such as atopic dermatitis, demonstrated that over 60% of patients experienced significant symptom improvement with galvokimig. Although data specifically for NCFB is limited, the mechanism of galvokimig suggests it might reduce airway inflammation and improve symptoms in NCFB. Researchers continue to study the treatment, which shows promise based on its effects in related conditions. Participants in this trial will receive varying doses of galvokimig or a placebo to assess its effectiveness and safety in treating NCFB.24567
Are You a Good Fit for This Trial?
This trial is for adults aged 18 to 80 who have been diagnosed with non-cystic fibrosis bronchiectasis, confirmed by a special lung scan (HRCT), and have symptoms like cough or frequent chest infections.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Galvokimig or placebo for 24 to 52 weeks to evaluate efficacy and safety
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Galvokimig
Trial Overview
The study compares the effects of galvokimig versus a placebo (inactive treatment) over 24 to 52 weeks. It looks at how long it takes before participants experience their next lung flare-up.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Participants randomly assigned to this arm will receive Galvokimig Dose 3
Participants randomly assigned to this arm will receive Galvokimig Dose 2
Participants randomly assigned to this arm will receive Galvokimig Dose 1
Participants randomly assigned to this arm will receive a matching Placebo.
Find a Clinic Near You
Who Is Running the Clinical Trial?
UCB Biopharma SRL
Lead Sponsor
Jean-Christophe Tellier
UCB Biopharma SRL
Chief Executive Officer since 2015
MD from University of Reims Champagne-Ardenne, Rheumatology specialization from University of Paris V, Executive business programs at Harvard and INSEAD
Dr. Iris Loew-Friedrich
UCB Biopharma SRL
Chief Medical Officer since 2014
MD from University of Leuven, PhD in Medical Sciences from University of Leuven
Citations
galvokimig (UCB9741) / UCB
ATMOS: A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis ...
Galvokimig Achieves High EASI Scores in Pilot Study
A new investigational therapy, galvokimig (UCB), has demonstrated encouraging early results in patients with moderate to severe atopic ...
246 Galvokimig, a multispecific antibody-based therapeutic ...
Galvokimig is a multispecific antibody-based therapeutic that inhibits IL-13, IL-17A, and IL-17F and has extended half-life provided by albumin binding. This ...
UCB announces successful first-in-patient trial for ...
More than 60% of patients achieved at least a 75% improvement in skin lesions: A median of 64.9% of patients treated with galvokimig versus 12.3% with ...
NCT07277660 | A Dose-ranging Study to Evaluate the ...
The purpose of the study is to evaluate the dose-response relationship of galvokimig compared with placebo in study participants with moderate-to-severe atopic ...
Galvokimig (UCB9741)
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 (ATMOS) ...
Galvokimig - Drug Targets, Indications, Patents
Safety of Galvokimig in … positive and convincing proof-of-concept data. First headline results are expected in 2028. Treatment with BIMZELX was generally well ...
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