402 Participants NeededMy employer runs this trial

Galvokimig for COPD

(SCALA Trial)

Recruiting at 6 trial locations
UC
UC
Overseen ByUCB Care
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: UCB Biopharma SRL
Must be taking: LABA, LAMA, ICS
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 investigates whether the medication galvokimig can delay worsening symptoms in people with COPD, a lung disease that makes breathing difficult, who have chronic bronchitis. Participants will receive different doses of galvokimig or a placebo, which is a non-active substance. The trial targets individuals with moderate-to-severe COPD who experience frequent flare-ups and currently use inhaled medications. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants must have been on a stable dose of certain inhaled therapies for at least 3 months before joining the study.

Is there any evidence suggesting that galvokimig is likely to be safe for humans?

Research has shown that galvokimig has been studied for its safety and effectiveness in treating chronic obstructive pulmonary disease (COPD). In earlier studies, most people tolerated galvokimig well. Safety data from a 12-week study indicated that most participants did not experience serious side effects. An 18-week study also confirmed that galvokimig was safe, with only minor side effects reported. These results suggest that galvokimig could be a safe option for managing COPD, although individual experiences may differ.12345

Why do researchers think this study treatment might be promising for COPD?

Galvokimig is unique because it offers a new approach for treating COPD by potentially targeting underlying inflammation more effectively than current treatments like bronchodilators and corticosteroids. Unlike these standard options, Galvokimig is designed to have a novel mechanism that directly interacts with specific inflammatory pathways, which could lead to better management of symptoms and possibly slow disease progression. Researchers are excited about Galvokimig because it might provide a more targeted therapy, offering hope for improved quality of life for patients with COPD.

What evidence suggests that galvokimig might be an effective treatment for COPD?

Research has shown that galvokimig targets proteins like IL-13, IL-17A, and IL-17F, which contribute to inflammation and can worsen chronic obstructive pulmonary disease (COPD) symptoms. Early studies on galvokimig in people with COPD have shown promise by possibly delaying the first severe flare-up, suggesting it could help reduce the frequency of serious COPD episodes. In this trial, participants will receive either galvokimig at one of two doses or a placebo, assigned randomly. However, more research is needed to fully understand its effectiveness for different patients.13467

Are You a Good Fit for This Trial?

This trial is for men and women aged 40–80 with moderate-to-severe COPD and chronic bronchitis, who are current or former smokers (at least 10 pack-years), have had recent flare-ups, use certain inhalers, can properly use inhalers/spirometry, and agree to contraception if needed.

Inclusion Criteria

Participant is a current or ex-smoker with tobacco smoking history of ≥10 pack-years
I have moderate-to-severe COPD with chronic bronchitis, diagnosed by my doctor.
Participant has a Chronic Airways Assessment Test (CAAT) score of ≥15 at Screening
See 7 more

Exclusion Criteria

Participant has uncontrolled neuropsychiatric disorder, active suicidal ideation, or positive suicidal behavior
Participant has absolute neutrophil count (ANC) <1.5 × 10³/μL
Participant has a history of past or current chronic alcohol or drug abuse within the previous 12 months
See 9 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 in COPD with chronic bronchitis

24 to 52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of AECOPD and adverse events

Up to 8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Galvokimig

Trial Overview

The study compares galvokimig (an investigational drug) to a placebo over 24–52 weeks. It aims to see if galvokimig helps delay the first COPD flare-up in people with moderate-to-severe COPD and chronic bronchitis.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: Galvokimig Dose 2 ArmExperimental Treatment1 Intervention
Group II: Galvokimig Dose 1 ArmExperimental Treatment1 Intervention
Group III: 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

NCT07725939 | A Study of 24 to 52 Weeks Treatment ...

The purpose of the study is to investigate the efficacy of galvokimig versus placebo in the time to the first acute exacerbation of chronic ...

Galvokimig (UCB9741)

Chronic Obstructive Pulmonary Disease A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Study Participants With Moderate ...

A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy ...

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

A Study of 24 to 52 Weeks Treatment to... | Clinical Trial

Brief Summary. The purpose of the study is to investigate the efficacy of galvokimig versus placebo in the time to the first acute exacerbation ...

Galvokimig - Drug Targets, Indications, Patents

The Efficacy And Safety of Galvokimig in Study Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease. First headline results are expected ...

A Study of 24 to 52 Weeks Treatment to Evaluate The ...

... Safety of Galvokimig in Study Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD) With Chronic Bronchitis.

UCB publishes new data on clinical trials for galvokimig

Global biopharmaceutical company UCB has announced new 12-week efficacy and 18-week safety data from the Phase I/IIa first-in-patient trial ...