300 Participants NeededMy employer runs this trial

Galvokimig for Bronchiectasis

(ATMOS Trial)

Recruiting at 3 trial locations
UC
Overseen ByUCB Cares
Prior Safety DataThis treatment has passed at least one previous human 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

Participant with post-Bronchodilator (BD) forced expiratory volume (FEV) 1% predicted ≥30% at Screening and Baseline
I have been diagnosed with non-cystic fibrosis bronchiectasis by a CT scan.
I am not pregnant or breastfeeding and will use birth control if I can have children.
See 6 more

Exclusion Criteria

I do not have active or untreated tuberculosis, and I am not at high risk for TB infection.
Participant has absolute neutrophil count (ANC) <1.5×10^3/μL, with one repeat test allowed
Participant has presence or first-degree family history of inflammatory bowel disease (IBD) including Crohn's disease and ulcerative colitis
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Galvokimig or placebo for 24 to 52 weeks to evaluate efficacy and safety

24 to 52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

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

Group I: Galvokimig Dose 3 ArmExperimental Treatment1 Intervention
Group II: Galvokimig Dose 2 ArmExperimental Treatment1 Intervention
Group III: Galvokimig Dose 1 ArmExperimental Treatment1 Intervention
Group IV: Placebo ArmPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

UCB Biopharma SRL

Lead Sponsor

Trials
118
Recruited
23,200+

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 ...