Verekitug for COPD

Recruiting at 5 trial locations

Overseen By Upstream Bio Clinical Trials Information (Privacy Notice: https://upstreambio.com/privacy-policy/)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Upstream Bio Inc.

Must be taking: Inhaled corticosteroids, LABA, LAMA

Must not be taking: Immunosuppressants, Cyclophosphamide, Rituximab

Disqualifiers: Asthma, Pulmonary fibrosis, Cardiovascular events, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

Duration: 60 to 108 weeks

666 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Justin Salciccioli, MD

Principal Investigator

Upstream Bio

Are You a Good Fit for This Trial?

This trial is for adults with moderate-to-severe COPD who have been diagnosed for over a year. Participants should be current or former smokers with significant smoking history, experience breathlessness, and have specific lung function test results. They must have been on stable triple therapy medication for COPD for at least one month.

Inclusion Criteria

I have smoked at least 10 pack-years.

I have taken at least 80% of my prescribed medication during the screening period.

I have been diagnosed with COPD for over a year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive verekitug or placebo subcutaneously every 12 or 24 weeks up to Week 96

60 to 108 weeks

Injections every 12 or 24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Verekitug

Trial Overview The study tests the effectiveness and safety of Verekitug compared to a placebo in improving symptoms of COPD. Patients will either receive Verekitug or a placebo without knowing which one they are getting to measure true effects.

How Is the Trial Designed?

Group I: Verekitug (UPB-101) 400 mg and Placebo Experimental Treatment 2 Interventions

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.

Group II: Verekitug (UPB-101) 100 mg and Placebo Experimental Treatment 2 Interventions

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.

Group III: Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Upstream Bio Inc.

Lead Sponsor

Trials

4

Recruited

570+