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 (SCALA)

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)

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 Overview

• Status: Not yet recruiting
• Conditions: Chronic Obstructive Pulmonary Disease With Chronic Bronchitis
• Intervention / Treatment: Biological: Galvokimig; Biological: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 402
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: UCB Cares; Phone Number: 1-844-599-2273 (USA); Email: ucbcares@ucb.com
• Study Contact Backup: Name: UCB Care; Phone Number: 0018445992273; Email: ucbcares@ucb.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Arm; Participants randomly assigned to this arm will receive a matching Placebo.	Biological: Placebo; Drug: Placebo Pharmaceutical form: Solution for injection
Experimental: Galvokimig Dose 1 Arm; Participants randomly assigned to this arm will receive a predefined Galvokimig Dose.	Biological: Galvokimig; Drug: Galvokimig Pharmaceutical form: Solution for injection; Other Names: UCB9741
Experimental: Galvokimig Dose 2 Arm; Participants randomly assigned to this arm will receive a predefined Galvokimig Dose.	Biological: Galvokimig; Drug: Galvokimig Pharmaceutical form: Solution for injection; Other Names: UCB9741

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from treatment assignment to first moderate or severe acute exacerbation of chronic obstructive pulmonary disease (AECOPD)	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.	Up to Week 60

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent (TE) Adverse Events (AE)	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.	Up to Week 60
Incidence of TE Serious Adverse Events (SAEs)	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.	Up to Week 60
Pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) at 24 weeks	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.	At Week 24
Annualized rate of moderate and severe AECOPD up to End of Treatment	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.	From Baseline up to Week 52
Change from Baseline at Week 24 in St. George's Respiratory Questionnaire-COPD-specific version (SGRQ-C)	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.	At Week 24
Proportion of participants with a decrease in SGRQ C total score of ≥4 points from Baseline 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.	From Baseline up to Week 24

Collaborators and Investigators

• Sponsor: UCB Biopharma SRL

Study record dates

Study Major Dates

• Study Start (Estimated): July 31, 2026
• Primary Completion (Estimated): June 29, 2029
• Study Completion (Estimated): June 29, 2029

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: COPD; AECOPD; Phase 2; Chronic bronchitis; UCB9741; Galvokimig; SCALA
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic
• Other Study ID Numbers: COPD01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
• IPD Sharing Time Frame: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
• IPD Sharing Access Criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No