Verekitug for COPD

Recruiting at 320 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?

This trial tests verekitug, a new treatment for individuals with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), a lung condition that makes breathing difficult. The goal is to determine the safety and effectiveness of this treatment for those with COPD. Participants will receive varying doses of verekitug or a placebo (a look-alike solution without active treatment) to compare results. Suitable candidates have had a COPD diagnosis for over a year, are current or former smokers with a significant smoking history, and experience noticeable shortness of breath. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

You will need to continue your current COPD medications, including inhaled corticosteroids, long-acting beta agonists, and long-acting muscarinic antagonists, as part of the trial. The protocol does not specify stopping other medications, but certain treatments like systemic immunosuppressants must be stopped well before the trial.

Is there any evidence suggesting that verekitug is likely to be safe for humans?

Research has shown that verekitug, the treatment under study for COPD (a lung disease that makes breathing difficult), works by blocking certain signals in the body that cause inflammation. This action is important because it helps lower the risk of serious lung flare-ups.

Regarding safety, previous patients have tolerated verekitug well, with no reports of major side effects, suggesting it is generally safe. As this trial is in the early stages, researchers continue to gather information on its safety and effectiveness. However, reaching this stage indicates promise in earlier safety tests. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for COPD?

Unlike the standard COPD treatments, such as bronchodilators and corticosteroids, Verekitug (UPB-101) offers a novel approach by targeting a different pathway. Researchers are excited about Verekitug because it is designed to work on specific inflammation pathways, potentially providing relief for patients who don't respond well to current therapies. Additionally, the treatment is administered subcutaneously, which might offer a more convenient dosing schedule compared to inhalers or oral medications. These features could make Verekitug a promising new option for managing COPD symptoms more effectively.

What evidence suggests that verekitug might be an effective treatment for COPD?

Research shows that verekitug stops a protein called TSLP, involved in inflammation, from connecting to its receptor. This action may reduce lung inflammation in people with COPD, a lung disease characterized by inflammation. Early findings suggest that verekitug is generally well tolerated, with no serious side effects reported. Initial data appears promising, but further research is needed to confirm its effectiveness for COPD. Participants in this trial will receive varying dosages of verekitug or a placebo to further evaluate its effectiveness and safety. ^{1 2 4 5 6}

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06981078

NCT06981078 | A Study to Assess the Efficacy and Safety ... The purpose of this study is to assess the efficacy and safety of verekitug (UPB-101) in participants with moderate-to-severe Chronic ...

2. investors.upstreambio.com investors.upstreambio.com/news-releases/news-release-details/upstream-bio-presents-data-showing-structural-and-mechanistic

Release Details Data show verekitug prevents TSLP binding to the TSLP receptor by occupying ligand binding sites – – Additionally, findings show that ...

3. clinicaltrialsarena.com clinicaltrialsarena.com/news/upstream-bio-verekitug/

First subject dosed in Upstream Bio's trial of verekitug for ... Upstream Bio has dosed the first subject in the Phase II trial of verekitug in individuals with chronic obstructive pulmonary disease ...

4. trial.medpath.com trial.medpath.com/clinical-trial/ca0a31ab974e4f73/nct06981078-verekitug-copd-efficacy-safety

A Study to Assess the Efficacy and Safety of Verekitug in ... This is a global, multicenter study to assess the efficacy, safety, and tolerability of verekitug in participants with moderate-to-severe COPD.

5. sec.gov sec.gov/Archives/edgar/data/2022626/000202262625000005/upb-ex99_1.htm

EX-99.1 Verekitug was generally well tolerated, demonstrating a favorable safety profile consistent with previous studies, with no SAEs observed.

6. ctv.veeva.com ctv.veeva.com/study/a-phase-2b-study-to-assess-the-efficacy-and-safety-of-verekitug-in-participants-with-copd

A Study to Assess the Efficacy and Safety of Verekitug in ... This is a global, multicenter study to assess the efficacy, safety, and tolerability of verekitug in participants with moderate-to-severe COPD.