A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Study Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD) With Chronic Bronchitis
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Study Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease With Chronic Bronchitis (SCALA)
- Chronic Obstructive Pulmonary Disease With Chronic Bronchitis
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- UCB Biopharma SRL
- Enrolment target
- 402
- Started
- 27 July 2026
- Main results due
- 29 June 2029
- Study sites
- 9
- Registry updated
- 25 September 2026
Can you take part?
- Ages 40 years to 80 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion criteria:
* Participant must be aged ≥40 to ≤80 years of age, inclusive, at the time of signing the Informed Consent form (ICF)
* Participant with a documented physician-diagnosed moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) with chronic bronchitis phenotype
* Participant has a documented record of receiving maintenance inhaled therapy at a stable dose for ≥3 months prior to Screening comprised of:
• long-acting beta2 agonist (LABA) +long-acting muscarinic antagonist (LAMA) ±inhaled corticosteroid (ICS)
* Participant at a high risk of exacerbations, defined as a documented exacerbation history of ≥2 moderate or severe acute exacerbation(s) of chronic obstructive pulmonary disease (AECOPD) in the 12 months prior to Screening or 1 severe AECOPD in the 6 months prior to Screening
* Participant has a Chronic Airways Assessment Test (CAAT) score of ≥15 at Screening
* Participant has acceptable inhaler 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 Periods 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, and at least one of the following conditions applies:
* Not a women of childbearing potential (WOCBP) OR
* A WOCBP who agrees to follow the contraceptive guidance during the Intervention Periods and for at least 60 days after the final dose of study intervention
* Participant is a current or ex-smoker (with tobacco smoking history of ≥10 pack-years)
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 history of uncompensated heart failure, fluid overload, or myocardial infarction, or evidence of new onset ischemic heart disease or in the opinion of the investigator other serious cardiac disease, within 12 months prior to Screening
* Participant has a presence or a family history (first degree) of inflammatory bowel disease (IBD)
* Participant has uncontrolled neuropsychiatric disorder, active suicidal ideation, or positive suicidal behavior
* Participant has a history of chronic or recurrent clinically significant infections, or a serious extrapulmonary infection within the 6 months prior to Baseline
* Participant has clinically important pulmonary disease other than COPD with chronic bronchitis
* Participant has hypercapnia requiring bilevel positive airway pressure (BiPAP)
* Participant has had a live or attenuated vaccines within 4 weeks prior to Screening or plans to receive such vaccines during the study
* Participant has relevant safety events to one or more interleukin (IL)-13 or IL-17 biologic response modifiers that resulted in discontinuation and change of treatment
* Participant has absolute neutrophil count (ANC) \<1.5 × 10³/μL
* Participant has a corrected QT interval (QTc) \>450msec for male participants or QTc \>470msec for female participants or QTc \>480 msec in participants with bundle branch block
* Participant has a history of past or current chronic alcohol or drug abuse within the previous 12 monthsWhat this study is about
In the sponsor’s own words, from the registry.
The purpose of the study is to investigate the efficacy of galvokimig versus placebo in the time to the first acute exacerbation of chronic obstructive pulmonary disease (AECOPD) in study participants with moderate-to-severe COPD with chronic bronchitis.
Study sites(9)
Copd01 50003
Columbus, Ohio, United States
Recruiting
Copd01 50002
DuBois, Pennsylvania, United States
Recruiting
Copd01 50001
Boerne, Texas, United States
Recruiting
Copd01 20001
Beijing, China
Recruiting
Copd01 20004
Chengdu, China
Recruiting
Copd01 20003
Hangzhou, China
Recruiting
Copd01 20005
Hangzhou, China
Recruiting
Copd01 20002
Nanchang, China
Recruiting
Copd01 20012
Shijiazhuang, China
Recruiting
Showing 9 of 9 sites. 9 of the 9 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07725939. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
Not the right study?
Answer three questions and see the studies recruiting near you, in plain language.
Find a study for me