Chronic Obstructive Pulmonary Disease With Chronic BronchitisPhase 2SCALANCT07725939
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 study testing Galvokimig in people with Chronic Obstructive Pulmonary Disease With Chronic Bronchitis, run by UCB Biopharma SRL at 26 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease With Chronic Bronchitis
- What is being tested?
- Galvokimig
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 402 participants
- Where
- 26 sitesin 2 countries
- Study dates
- 27 Jul 2026to 29 Jun 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
26 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
26 sites in 2 countries
United States16 sites, 16 recruiting
- Recruiting
Copd01 50001
Boerne, Texas, 78006
- Recruiting
Copd01 50017
Charlotte, North Carolina, 28277
- Recruiting
Copd01 50003
Columbus, Ohio, 43215
- Recruiting
Copd01 50002
DuBois, Pennsylvania, 15801
- Recruiting
Copd01 50021
Encino, California, 91436
- Recruiting
Copd01 50006
McKinney, Texas, 75069
- Recruiting
Copd01 50019
Medford, Oregon, 97504
- Recruiting
Copd01 50011
Miami, Florida, 33126
- Recruiting
Copd01 50020
North Charleston, South Carolina, 29406
- Recruiting
Copd01 50008
Rincon, Georgia, 31326
- Recruiting
Copd01 50004
Rock Hill, South Carolina, 29732
- Recruiting
Copd01 50013
Seattle, Washington, 98122
- Recruiting
Copd01 50009
Spartanburg, South Carolina, 29303
- Recruiting
Copd01 50005
Tomball, Texas, 77375
- Recruiting
Copd01 50010
Union, South Carolina, 29379
- Recruiting
Copd01 50016
Westminster, California, 92683
China10 sites, 10 recruiting
- Recruiting
Copd01 20001
Beijing
- Recruiting
Copd01 20004
Chengdu
- Recruiting
Copd01 20006
Guangzhou
- Recruiting
Copd01 20003
Hangzhou
- Recruiting
Copd01 20005
Hangzhou
- Recruiting
Copd01 20002
Nanchang
- Recruiting
Copd01 20008
Shenzhen
- Recruiting
Copd01 20012
Shijiazhuang
- Recruiting
Copd01 20015
Yangzhou SHI
- Recruiting
Copd01 20007
Zhanjiang
About this study
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)
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.
- Being tested
- Galvokimig, Placebo
- Keywords
- Phase 2, COPD, SCALA, Galvokimig, UCB9741, Chronic bronchitis, AECOPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GalvokimigBiological
Also called UCB9741
Drug: Galvokimig Pharmaceutical form: Solution for injection
PlaceboBiological
Drug: Placebo Pharmaceutical form: Solution for injection
| Study group | Role | What they receive |
|---|---|---|
| Galvokimig Dose 1 Arm | Experimental | Participants randomly assigned to this arm will receive a predefined Galvokimig Dose. Receives: Biological: Galvokimig |
| Galvokimig Dose 2 Arm | Experimental | Participants randomly assigned to this arm will receive a predefined Galvokimig Dose. Receives: Biological: Galvokimig |
| Placebo Arm | Placebo comparator | Participants randomly assigned to this arm will receive a matching Placebo. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Week 60
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Baseline up to Week 24
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.
Measured: 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.
Measured: Up to Week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start27 Jul 2026
- Primary completion29 Jun 2029 (estimated)
- Study completion29 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease With Chronic BronchitisStudies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 402 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725939
- Sponsor's protocol ID
- COPD01
- Other IDs
- 2026-525523-25-00, U1111-1337-0331
- Acronym
- SCALA
- Status last verified
- Nov 2026
- First submitted
- 21 Jul 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07725939
- Acronym / sponsor ID
- SCALA / COPD01
- Keywords
- Phase 2, COPD, SCALA, Galvokimig, UCB9741, Chronic bronchitis, AECOPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 402 participants (estimated)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2026 (actual)
- Primary completion
- 29 Jun 2029 (estimated)
- Study completion
- 29 Jun 2029 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Galvokimig Dose 1 Arm | Experimental | Biological: GalvokimigParticipants randomly assigned to this arm will receive a predefined Galvokimig Dose. |
| Galvokimig Dose 2 Arm | Experimental | Biological: GalvokimigParticipants randomly assigned to this arm will receive a predefined Galvokimig Dose. |
| Placebo Arm | Placebo comparator | Biological: PlaceboParticipants randomly assigned to this arm will receive a matching Placebo. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GalvokimigAlso: UCB9741Drug: Galvokimig Pharmaceutical form: Solution for injection | Biological | Galvokimig Dose 1 Arm, Galvokimig Dose 2 Arm |
| PlaceboDrug: Placebo Pharmaceutical form: Solution for injection | Biological | Placebo Arm |
Primary outcome
Time from treatment assignment to first moderate or severe acute exacerbation of chronic obstructive pulmonary disease (AECOPD)
Time frame: 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.
6 secondary outcomes
Pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) at 24 weeks
Time frame: At Week 24
Annualized rate of moderate and severe AECOPD up to End of Treatment
Time frame: From Baseline up to Week 52
Change from Baseline at Week 24 in St. George's Respiratory Questionnaire-COPD-specific version (SGRQ-C)
Time frame: At Week 24
Proportion of participants with a decrease in SGRQ C total score of ≥4 points from Baseline to Week 24
Time frame: From Baseline up to Week 24
Incidence of Treatment-Emergent (TE) Adverse Events (AE)
Time frame: Up to Week 60
Incidence of TE Serious Adverse Events (SAEs)
Time frame: Up to Week 60
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Galvokimig in people with Chronic Obstructive Pulmonary Disease With Chronic Bronchitis, run by UCB Biopharma SRL at 26 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact UCB Cares (1-844-599-2273 (USA), ucbcares@ucb.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from treatment assignment to first moderate or severe acute exacerbation of chronic obstructive pulmonary disease (AECOPD) (time frame: Up to Week 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.