COPD Acute Exacerbation
Conditions
Keywords
COPD, chronic obstructive pulmonary disease, rademikibart, Connect Biopharma, CBP-201, COPD exacerbation, type 2 inflammation
Brief summary
This is a Phase 2, multicenter study in adult participants with an acute COPD exacerbation and type 2 inflammation
Detailed description
This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, interventional trial in participants with an acute COPD exacerbation with type 2 inflammation in the urgent healthcare setting to compare rademikibart plus standard therapy to standard therapy (plus placebo).
Interventions
COMBINATION_PRODUCTRademikibart in prefilled syringe
Participants receive 600 mg (4mL) of rademikibart administered subcutaneously.
Participants receive 4mL of placebo matched to rademikibart administered subcutaneously.
Sponsors
Connect Biopharm LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Physician-diagnosed COPD with duration of ≥12 months. * Must have experienced at least 1 COPD exacerbation requiring the use of systemic corticosteroids. * Participants in a stable condition must have a documented historical peripheral blood eosinophil count of ≥250 cells/μL and/or FeNO ≥ 25 ppb. * Current or former smoker with a history of smoking of ≥10 pack-years. * Current acute COPD exacerbation requiring an urgent healthcare visit for treatment. * Peripheral blood eosinophil count of ≥300 cells/μL as part of the assessment of the index acute COPD exacerbation. * Requires systemic corticosteroids as standard of care treatment in the urgent healthcare setting for the current acute COPD exacerbation.
Exclusion criteria
* Regular use of immunosuppressive medication 12 weeks or 5 half-lives prior to randomization, whichever is longer. * Current diagnosis or a history of asthma, according to the Global Initiative for Asthma; or participants with a current diagnosis or history of Asthma COPD Overlap Syndrome. * Other respiratory disorders that might compromise the safety of the participant or affect the interpretation of the results. * Unstable ischemic heart disease, cardiomyopathy, heart failure (New York Heart Association Class III or IV), uncontrolled hypertension. Cardiac arrhythmias including paroxysmal atrial fibrillation. * Transient ischemic attack or stroke \<6 months from Screening Visit; hospitalization for any cardiovascular or cerebrovascular event \<6 months from Screening Visit. * Known or suspected history of immunosuppression. * History of known immunodeficiency disorder or hepatitis B or C. * History of alcohol abuse and/or drug abuse. * Recent history of cancer except basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success. * Chronic treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for \>15 hours a day. * Participants on long-term macrolide. * Current acute COPD exacerbation for which SoC was started \>48 hours prior to Screening. * A recent chest X-ray or computed tomography (CT) scan at Screening reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD, or a clinically significant pulmonary infection identified by chest X-ray (CT scan). * Female participant who is pregnant, lactating or breast-feeding, or has a positive urinary β-hCG test prior to randomization. * Receipt of any marketed nonbiologic drug that modulates type 2 cytokines 30 days or 5 half-lives prior to randomization, whichever is longer. * Receipt of any marketed or any investigational biologic for COPD or other diseases within 16 weeks or 5 half-lives prior to randomization, whichever is longer. * Live, attenuated vaccinations within 4 weeks prior to randomization or planned live, attenuated vaccinations during the trial. * Treatment with systemic corticosteroids (ie, oral or by injection) and/or hospitalization for an exacerbation of COPD completed less than 4 weeks prior to randomization. The above inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment failure rate | 28 days | Treatment failure is defined as death due to any cause, (re)admission to a hospital for COPD, ED (re)visit or unscheduled medical visit for worsening of COPD symptoms, or the necessity to intensify pharmacologic treatment (including second course of systemic steroids for COPD exacerbation) within 28 days after randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute change from baseline (CFB) in post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) at Week 1 | Week 1 | — |
| Rate of new moderate and severe COPD exacerbations over the 28 days after randomization | 28 days | — |
| Time to the first new moderate or severe COPD exacerbation in the 28 days after randomization | 28 days | — |
| Mean CFB in EXACT-PRO score | Week 1, Week 2, and Week 4 | Mean CFB in clinical respiratory symptoms of COPD using the E-RS: COPD (Evaluating Respiratory Symptoms in COPD) comprised in the EXACT-PRO through Week 1, Week 2, and Week 4. The Exacerbations of Chronic Pulmonary Disease Tool - Patient-Reported Outcome (EXACT-PRO) is a PRO instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in patients with COPD. |
| Absolute CFB in post-BD FEV1 at Day 3 and Week 4 | Day 3, Week 1, and Week 4 | Absolute change from baseline in post-bronchodilator forced expiratory volume (FEV1) at Day 3, Week 1, and Week 4 |
| Incidence of adverse events (AEs), including serious adverse events (SAEs), adverse event of special interest (AESIs), and drug-induced liver injury (DILI) reported | 56 days | — |
| Incidence of unanticipated adverse device effects (UADEs) | 56 days | — |
| Incidence of injection site reactions | 56 days | — |
Countries
Argentina, Australia, Georgia, Serbia, United Kingdom, United States
Outcome results
None listed