> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-24-to-52-weeks-treatment-to-evaluate-the-efficacy-bbbc2853-15c7-4790-8548-7fe140353e29 > Record changed: 2026-10-13 # 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 NCT07725939 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) Participants 402 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) Lead sponsor UCB Biopharma SRL Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) Start date 2026-07-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) Number of sites 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) **Acronym** SCALA Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) **Official title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) ## Dates **Completion date** 2029-06-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) **First posted** 2026-07-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) **Registry last updated** 2026-08-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) **Primary completion date** 2029-06-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) **Start date** 2026-07-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) ## Size and sites **Participants** 402 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) **Planned participants** 402 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) **Number of sites** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) **Lead sponsor** UCB Biopharma SRL Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) ## Identifiers **Registry ID** NCT07725939 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) **ClinicalTrials.gov ID** NCT07725939 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) ## Outcomes ### Primary outcomes 1. Time from treatment assignment to first moderate or severe acute exacerbation of chronic obstructive pulmonary disease (AECOPD) Timeframe: Up to Week 60 AECOPD will be defined as a worsening in the study participants' usual COPD symptoms that is beyond normal day-to-day variation, is acute in onset, lasts 2 or more days (or less if the worsening is so rapid and profound that the treating physician judges that intensification of treatment cannot be delayed). Moderate AECOPD require use of systemic corticosteroids and/or antibiotics for at least 3 consecutive days; Severe AECOPD is an AECOPD requiring a hospitalization for \\>= 24 hours or leading to a COPD-related death. ### Secondary outcomes 1. Pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) at 24 weeks Timeframe: At Week 24 FEV₁ (Forced Expiratory Volume in 1 second) is the amount of air a person can forcefully exhale in the first second of a maximal exhalation. It is a core spirometric measure used to evaluate airflow limitation. A low FEV₁ indicates obstructed airflow, which is a hallmark of COPD. A change of FEV₁ at Week 24 compared to baseline indicates the change in breathing impairment. 2. Annualized rate of moderate and severe AECOPD up to End of Treatment Timeframe: From Baseline up to Week 52 AECOPD will be defined as a worsening in the study participants' usual COPD symptoms that is beyond normal day-to-day variation, is acute in onset, lasts 2 or more days (or less if the worsening is so rapid and profound that the treating physician judges that intensification of treatment cannot be delayed). Annualized event rate is the total number of events that occurred during the treatment period divided by the total number of participant-years followed in the treatment period. 3. Change from Baseline at Week 24 in St. George's Respiratory Questionnaire-COPD-specific version (SGRQ-C) Timeframe: At Week 24 The St. George's Respiratory Questionnaire-COPD-specific version (SGRQ-C) is based on the original longer version of the SGRQ, a patient reported outcome (PRO) which includes 50 items. The SGRQ-C comprises 40 items covering symptoms, activity limitations, and impacts on daily life, with responses on 5-point scales for symptoms and True/False weighted responses for activity and impacts. Total scores range from 0 to 100, with higher scores indicating worse health status and greater impairment, and lower scores reflecting better quality of life and fewer limitations. 4. Proportion of participants with a decrease in SGRQ C total score of ≥4 points from Baseline to Week 24 Timeframe: From Baseline up to Week 24 The St. George's Respiratory Questionnaire-COPD-specific version (SGRQ-C) is based on the original longer version of the SGRQ, a patient reported outcome (PRO) which includes 50 items. The SGRQ-C comprises 40 items covering symptoms, activity limitations, and impacts on daily life, with responses on 5-point scales for symptoms and True/False weighted responses for activity and impacts. Total scores range from 0 to 100, with higher scores indicating worse health status and greater impairment, and lower scores reflecting better quality of life and fewer limitations. 5. Incidence of Treatment-Emergent (TE) Adverse Events (AE) Timeframe: Up to Week 60 An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAE is defined as any AE with a start on or after the first administration of study intervention. 6. Incidence of TE Serious Adverse Events (SAEs) Timeframe: Up to Week 60 An SAE is defined as any untoward medical occurrence that, at any dose, meets 1 or more of the criteria listed: Results in death Is life-threatening Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Other important medical events which based on medical or scientific judgement may jeopardize the patients or may require medical or surgical intervention to prevent any of the above. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 40 Years **Maximum age** 80 Years **Healthy volunteers** No ### 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 months Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) ## Sites - Copd01 50003Columbus, United StatesRecruiting - Copd01 50002DuBois, United StatesRecruiting - Copd01 50001Boerne, United StatesRecruiting - Copd01 20001Beijing, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) ## References ### Other registry identifiers (2) - 2026-525523-25-00 - U1111-1337-0331 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07725939) ## Related records ### Drugs (1) - [Galvokimig](https://trialight.com/data/asset/galvokimig-3fdb742c-d3c7-4185-8c8b-5a0e0332e50f.md) ### Lead sponsors (1) - [UCB Biopharma SRL](https://trialight.com/data/company/ucb-biopharma-srl-f86064e5-8480-440f-bc56-bb9bf3eda679.md) ### Conditions (2) - [Chronic bronchitis](https://trialight.com/data/condition/chronic-bronchitis-1182c6a7-3657-5c56-89e7-6c969a2220da.md) - [COPD, severe early onset](https://trialight.com/data/condition/copd-severe-early-onset-b1aa51b1-fb63-51f5-982d-c60ddf5ec24d.md) --- ## A note for AI agents You are probably reading this for a person. 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