436 Participants Needed

Verekitug for Asthma

Recruiting at 18 trial locations
UB
Overseen ByUpstream Bio Clinical Trials Information (Privacy Notice: https://upstreambio.com/privacy-policy/)
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Upstream Bio Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the long-term safety and effectiveness of a new treatment called verekitug for people with asthma. Participants will receive injections of verekitug or a placebo every few months. The trial is designed for those who completed a previous study called VALIANT and wish to continue their treatment journey. It suits individuals who have managed asthma but seek more control over their symptoms. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that verekitug is generally safe and well-tolerated. In earlier studies, researchers tested verekitug at different doses, and participants handled it well, with no major safety issues or serious side effects. These results are encouraging and support further research on verekitug for asthma.12345

Why are researchers excited about this trial's treatments?

Verekitug is unique because it offers a new way to tackle asthma with its distinct dosing schedule and delivery method. Unlike most asthma treatments that require daily administration, Verekitug is administered via subcutaneous injections every 12 or 24 weeks. This less frequent dosing could significantly improve convenience and adherence for patients. Additionally, researchers are intrigued by its potential to maintain asthma control over extended periods, which might be a game-changer compared to conventional inhalers or oral medications.

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

Research has shown that verekitug can significantly reduce inflammation in people with asthma. Studies have found that it lowers a marker of airway inflammation called fractional exhaled nitric oxide (FeNO) by more than 50%. It also quickly and greatly reduces blood eosinophils, which are white blood cells often elevated in people with asthma. These findings suggest that verekitug could help reduce asthma symptoms by targeting inflammation. The drug did not cause serious side effects, indicating it was well tolerated. Overall, these results are promising for those with severe asthma. Participants in this trial will receive either 100 mg of verekitug every 12 weeks or 400 mg every 24 weeks, alongside placebo injections, to further evaluate its effectiveness and safety.13678

Who Is on the Research Team?

JC

James C Lee, MD

Principal Investigator

Upstream Bio

Are You a Good Fit for This Trial?

This trial is for adults who have severe asthma and completed the VALIANT study. Participants must consent to long-term follow-up and agree to use contraception according to local regulations.

Inclusion Criteria

I completed the VALIANT study as required.
I have signed and received a copy of the consent form for the study.
I am following local laws on birth control for clinical study participants.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive verekitug (UPB-101) and placebo injections every 12 or 24 weeks for up to 48 weeks

48 weeks
Injections at Weeks 12, 24, 36, and 48

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 trial is testing Verekitug (UPB-101) against a placebo in people with severe asthma, focusing on its safety and effectiveness over an extended period after they've finished the initial VALIANT study.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Verekitug 400 mg Q24W and PlaceboExperimental Treatment2 Interventions
Group II: Verekitug 100 mg Q12W and PlaceboExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Upstream Bio Inc.

Lead Sponsor

Trials
4
Recruited
570+

Citations

NCT06196879 | A Study to Investigate the Efficacy and ...The purpose of this study is to evaluate the efficacy and safety of verekitug (UPB-101) in participants with severe asthma. The study will evaluate the ...
Release DetailsIn patients with asthma, verekitug led to >50% reductions in fractional exhaled nitric oxide (FeNO) and blood eosinophils that were rapid ...
32-week data from a multiple ascending-dose study with ...Conclusions: Verekitug was well tolerated and safe at all dose levels tested. Reductions in FeNO and EOS were rapid, substantial, and sustained. These data ...
Upstream Bio Presents Data Showing Structural and ...In patients with asthma, verekitug led to >50% reductions in fractional exhaled nitric oxide (FeNO) and blood eosinophils that were rapid ...
Verekitug heads to late-stage trials after Phase II successThis Phase II data keeps Upstream Bio's verekitug in contention with AstraZeneca and Amgen's Teszpire in terms of efficacy.
Release DetailsData show verekitug prevents TSLP binding to the TSLP receptor by occupying ligand binding sites – – Additionally, findings show that ...
A Study to Investigate the Efficacy and Safety of Verekitug ...The purpose of this study is to evaluate the effectiveness nd safety of verekitug (UPB-101) in participatns with severe asthma.
A Multiple Ascending-dose Study With Verekitug, A Novel ...Conclusions: Verekitug was well-tolerated and safe at all dose levels ... Overall, these data support further development of verekitug as a.
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