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)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 40 Years to 80 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Mentioned in the study description
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Mentioned in the study description
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests galvokimig against a placebo (a treatment with no active drug) for 24 to 52 weeks. It looks at safety and how long it takes before the first sudden COPD flare-up. It is for adults with moderate-to-severe COPD, a long-term lung disease, and chronic bronchitis, which causes lasting swelling in the airways.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 40 to 80 years old when signing the consent form.
- Have a doctor's confirmed diagnosis of moderate-to-severe COPD with chronic bronchitis.
- Have used both LABA and LAMA long-acting inhaled medicines at a steady dose for at least 3 months before screening, with or without an inhaled steroid.
- Have had at least 2 moderate or severe COPD flare-ups in the past 12 months, or 1 severe flare-up in the past 6 months.
- Have a score of at least 15 on the Chronic Airways Assessment Test, a breathing symptom survey, at screening.
- Be able to use an inhaler and do spirometry, a breathing test, correctly at screening.
- Men must use birth control and not donate sperm during treatment and for at least 60 days after the last dose. Women must not be pregnant or breastfeeding. Women who can become pregnant must follow birth control rules for the same period.
- Currently smoke or have smoked in the past, with at least 10 pack-years of tobacco use—for example, 1 pack a day for 10 years.
Who can't join
- Have a health or mental health condition, exam finding, or test result that the study doctor believes could make treatment unsafe, affect study results, or prevent participation.
- Have had poorly controlled heart failure, fluid overload, a heart attack, new heart disease from low blood flow, or another serious heart condition in the past 12 months. Certain abnormal heart rhythm test results also rule out participation.
- Have inflammatory bowel disease (long-term swelling in the gut), or a parent, sibling, or child with it.
- Have an uncontrolled brain or mental health disorder, current thoughts of suicide, or suicidal behavior; or have had ongoing alcohol or drug abuse in the past 12 months.
- Have long-lasting or repeated important infections, or a serious infection outside the lungs in the 6 months before the study's starting visit. Have a neutrophil count (infection-fighting white blood cells) below 1,500 per microliter.
- Have another important lung disease, or high carbon dioxide levels that require BiPAP, a machine that helps with breathing.
- Have received a live or weakened-live vaccine within 4 weeks before screening, or plan to get one during the study.
- Have had safety problems with IL-13 or IL-17 biologic medicines, which affect the immune system, that required stopping and changing treatment.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 months
Study sites (7)
FL
- Copd01 50011 · Miami, FL 33126More trials in Miami
GA
- Copd01 50008 · Rincon, GA 31326More trials in Rincon
OH
- Copd01 50003 · Columbus, OH 43215More trials in Columbus
PA
- Copd01 50002 · DuBois, PA 15801More trials in DuBois
TX
- Copd01 50001 · Boerne, TX 78006More trials in Boerne
- Copd01 50005 · Tomball, TX 77375More trials in Tomball
WA
- Copd01 50013 · Seattle, WA 98122More trials in Seattle