Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Brief summary
Annualized rate of moderate or severe COPD exacerbation events compared with placebo over 108 weeks of treatment.
Detailed description
Change in pre-bronchodilator FEV1 compared with placebo from baseline to Week 60., Annualized rate of severe COPD exacerbation events compared with placebo over 108 weeks of treatment., Change in St. George’s Respiratory Questionnaire (SGRQ) total score compared with placebo from baseline to Week 60., Proportion of participants with SGRQ improvement of >4 points compared with placebo at Week 60., Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)., Serum concentrations of verekitug and PK profile., Incidence of anti-drug antibodies (ADAs) during the study (including the post-treatment follow-up period).
Interventions
DRUGVerekitug (UPB-101) Placebo
Sponsors
Upstream Bio Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualized rate of moderate or severe COPD exacerbation events compared with placebo over 108 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in pre-bronchodilator FEV1 compared with placebo from baseline to Week 60., Annualized rate of severe COPD exacerbation events compared with placebo over 108 weeks of treatment., Change in St. George’s Respiratory Questionnaire (SGRQ) total score compared with placebo from baseline to Week 60., Proportion of participants with SGRQ improvement of >4 points compared with placebo at Week 60., Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)., Serum concentrations of verekitug and PK profile., Incidence of anti-drug antibodies (ADAs) during the study (including the post-treatment follow-up period). | — |
Countries
Bulgaria, Czechia, Germany, Hungary, Ireland, Latvia, Lithuania, Poland, Romania, Slovakia, Spain
Outcome results
None listed