A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety And Efficacy Of Umc119-06-05 Intravenous Infusion For The Treatment Of Subjects With Moderate To Severe Chronic Obstructive Pulmonary Disease
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Chronic Obstructive Pulmonary Disease
- Sponsor
- Meribank Biotech Co., Ltd.
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- Incidence of treatment-emergent adverse events (TEAEs)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
This phase II study is a randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of UMC119-06-05 compared to placebo in treating subjects with moderate to severe COPD. Eligible subjects will receive a single-dose IV infusion of UMC119-06-05 or placebo.
Detailed Description
Patients with chronic obstructive pulmonary disease (COPD) are characterized with airflow limitation and chronic inflammation, which is caused by cigarette smoking, noxious particles or gases. These inhaled irritants will induce inflammation, emphysema and fibrosis though chronic exposure. The current pharmacological treatment of COPD is symptomatic and is mainly based on bronchodilators and corticosteroids. Although current clinical treatment strategies can improve and stabilize COPD states and quality of life, none of them are able to modify the progressive decline in lung function, meaning it gradually gets worse over time. Therefore, development of new therapeutic modalities to improve the clinical outcomes and prognosis of COPD in adult patients is of urgent need. Among the more innovative, experimental therapies, mesenchymal stromal cells are proposed as a novel therapy with potential in treatment of COPD. This clinical trial is a phase II study. It is a randomized, placebo-controlled, double-blind study. Eligible subjects will be randomized to one of the three groups: placebo control, low-dose UMC119-06-05 treatment, or high-dose UMC119-06-05 treatment. Subjects will receive a single-dose IV infusion to evaluate the efficacy and long-term safety of UMC119-06-05 with moderate to severe COPD.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Between ≥40 and ≤80 years of age, of either sex and of any race.
- •With diagnosis of COPD based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) standard.
- •Has a post-bronchodilator FEV1/FVC ratio \<0.
- •Has a post-bronchodilator FEV1 predicted value ≥30% and \<80%.
- •With a score ≥2 in the mMRC dyspnea scale.
- •With a score ≥10 in the COPD Assessment Test (CAT).
- •With a body weight ≥40 to ≤90 kg.
- •The disease status of COPD has been stable as determined by the investigator, and the standard treatment for COPD was not adjusted within 3 months prior to screening.
- •Is a current or ex-smoker, with a cigarette smoking history of ≥10 years or \>10 pack-years.
- •Women of child-bearing potential should have a negative urine pregnancy test at screening, UNLESS they meet the following criteria:
Exclusion Criteria
- •Has evidence of active malignancy or prior history of active malignancy that has not been in complete remission for at least 5 years prior to screening.
- •Diagnosed with asthma or other clinically relevant lung disease other than COPD (e.g., restrictive lung diseases, sarcoidosis, tuberculosis, idiopathic pulmonary fibrosis, bronchiectasis, or lung cancer).
- •Has initiated pulmonary rehabilitation (e.g., exercise training) within 3 months prior to screening which, in the opinion of the Principal Investigator (PI), may affect the study's results.
- •Has documented history of uncontrolled heart failure.
- •Has pulmonary hypertension due to left heart condition.
- •Has atrial fibrillation or significant congenital heart defect/disease.
- •Has had a moderate or severe exacerbation of COPD (defined by GOLD standard) or has required mechanical ventilation (not including continuous positive airway pressure \[CPAP\]) within 30 days prior to screening.
- •Is hospitalized at screening.
- •With current active infection including pulmonary infection, systemic infection, or severe local infections.
- •Have the following conditions in laboratory tests at screening:
Outcomes
Primary Outcomes
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: From Baseline to Day 90]
Incidence of any treatment-emergent serious adverse events (SAE), defined as the composite of: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities. 2.Incidence of related TEAEs and serious adverse events (SAEs) 3.Incidence of withdrawals due to adverse events (AEs) 4.Change/shift from baseline in laboratory tests 5.Change from baseline in vital signs 6.Shift from baseline in ECG results 7.Shift from baseline in physical examination results
Incidence of related TEAEs and serious adverse events (SAEs)
Time Frame: through the study
Incidence of any treatment-emergent serious adverse events (SAE), defined as the composite of: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities. 2.Incidence of related TEAEs and serious adverse events (SAEs) 3.Incidence of withdrawals due to adverse events (AEs) 4.Change/shift from baseline in laboratory tests 5.Change from baseline in vital signs 6.Shift from baseline in ECG results 7.Shift from baseline in physical examination results
Change/shift from baseline in laboratory tests
Time Frame: Baseline, 2 hours (h), Days 3, 7, 14, 28, 90
laboratory tests
shift from baseline in ECG results
Time Frame: Baseline, 2 h, Day 14
ECG check
Incidence of withdrawals due to adverse events (AEs)
Time Frame: through the study
AE incidence
Change from baseline in vital signs
Time Frame: Baseline, 0 minute, 2 h, Days 3, 7, 14, 28, 90
measure vital signs
Shift from baseline in physical examination results
Time Frame: Baseline, 2 h, Days 3, 7, and 14
physical examination
Secondary Outcomes
- Incidence, frequency, and severity of COPD exacerbations(through the study)
- 9. Mean change or shift from baseline in Body mass index, airflow Obstruction, Dyspnea, and Exercise capacity (BODE) index(baseline to Days 28, 90, 180, 270, 360)
- he number of times that rescue medication is used(through the study)
- Mean change from baseline in forced vital capacity (FVC)(Baseline, Days 28, 90, 180, 270, 360)
- Mean change from baseline in forced expiratory volume in one second (FEV1)(Baseline, Days 28, 90, 180, 270, 360)
- Mean change from baseline in St. George's Respiratory Questionnaire (SGRQ) score(Baseline, Days 28, 90, 180, 270, 360)
- Time to first COPD exacerbation(through the study)
- Mean change from baseline in FEV1/FVC ratio(Baseline, Days 28, 90, 180, 270, 360)
- Mean change from baseline in 6-minute walk test(Baseline, Days 28, 90, 180, 270, 360)
- Shift from baseline in modified Medical Research Council (mMRC) dyspnea scale(Baseline, Days 28, 90, 180, 270, 360)