A Study to Assess the Efficacy and Safety of Verekitug in Participants With COPD
Purpose
The purpose of this study is to assess the efficacy and safety of verekitug (UPB-101) in participants with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), an inflammatory lung disease.
Condition
- Chronic Obstructive Pulmonary Disease
Eligibility
- Eligible Ages
- Between 40 Years and 85 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Physician diagnosis of COPD for >12 months. - Current or former smokers with a smoking history of 10 pack-years or more. - Post-bronchodilator FEV1/ Forced Vital Capacity (FVC) ratio <0.70 and predicted post-bronchodilator FEV1 >30% and ≤80%. - Modified Medical Research Council dyspnea scale Grade ≥2. - Background triple therapy (Inhaled Corticosteroid [ICS], Long-Acting Beta Agonist [LABA], Long-Acting Muscarinic Antagonist [LAMA]) for 3 months before randomization with a stable dose of medications for 1 or more months prior to Visit 1. - Are ≥80% compliant with background therapy during the screening period.
Exclusion Criteria
- Moderate or severe exacerbation of COPD within 4 weeks prior to or during the screening period. - Respiratory tract infection within 4 weeks prior to or during the screening period. - Treatment with oxygen of >4 liters/minute. Nocturnal oxygen use for sleep apnea is allowed. - Systemic or biologic immunosuppressant therapy to treat inflammatory disease or autoimmune disease within 24 weeks or 5 half-lives prior to Visit 1, whichever is longer, with the exception of oral corticosteroids. Treatment with cyclophosphamide and rituximab within 12 months of Visit 1. - Current diagnosis of asthma according to the 2023 Global Initiative for Asthma guidelines or other accepted guidelines - History or evidence of a clinically meaningful pulmonary condition other than COPD (e.g., pulmonary fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts. - Chronic hypercapnia requiring Bilevel Positive Airway Pressure (BiPAP). Participants requiring BiPAP periodically for an acute COPD exacerbation are not excluded. - Any of the following in the previous 6 months prior to Visit 1: acute myocardial infarction, transient ischemic attack or stroke, hospitalization for any cardiovascular or cerebrovascular event, pulmonary embolism, deep vein thrombosis and cardiac arrhythmias including paroxysmal (e.g., intermittent). Participants with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy (i.e., selective beta blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) and stable appropriate level of anticoagulation for at least 6 months may be considered for inclusion.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Verekitug (UPB-101) 100 mg and Placebo |
Participants will receive 0.5 milliliter (mL) of the formulated solution (containing 100 milligrams [mg] of verekitug [UPB-101]) and 2.0 mL of matching placebo subcutaneously in two separate injections every 12 weeks up to Week 96. |
|
|
Experimental Verekitug (UPB-101) 400 mg and Placebo |
Participants will receive 2.0 mL of the formulated solution (containing 400 mg of verekitug [UPB-101]) and 0.5 mL of matching placebo subcutaneously in two separate injections every 24 weeks up to Week 96. Participants will also receive 2.0 mL and 0.5 mL of matching placebo subcutaneously in two separate injections at Weeks 12, 36, 60 and 84 visits. |
|
|
Placebo Comparator Placebo |
Participants will receive 0.5 mL of matching placebo and 2.0 mL of matching placebo subcutaneously in two separate injections every 12 weeks up to Week 96. |
|
More Details
- Status
- Recruiting
- Sponsor
- Upstream Bio Inc.
Study Contact
Upstream Bio Clinical Trials Information (Privacy Notice: https://upstreambio.com/privacy-policy/)888-446-3130
clinicaltrials@upstreambio.com
Detailed Description
This is a global, multicenter study to assess the efficacy, safety, and tolerability of verekitug in participants with moderate-to-severe COPD. Adult participants are planned to be enrolled and will be allocated randomly in a 1:1:1 ratio to one of two dose levels of verekitug or placebo, in addition to their COPD background medications. The study consists of a screening period of approximately 4 weeks; treatment periods of between 60 weeks and up to 108 weeks; and a follow-up period, with the end-of-study visit 16 weeks after last dose.