Active not recruitingPHASE2INTERVENTIONAL

A Long-Term Safety and Efficacy Study of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALOUR)

This research study, called VALOUR, is investigating the long-term safety and effectiveness of a new treatment for severe asthma named verekitug (UPB-101). It is specifically designed for adults who have already participated in and completed a previous study called VALIANT (NCT06196879). The main goal is to understand how well verekitug works over an extended period and whether it is safe for continued use in people living with severe asthma. Participants will either continue with verekitug or receive a placebo. This type of study helps doctors learn more about potential new treatments and how they might help patients in the future.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Upstream Bio Inc.

Enrolment target

396

Start

21 May 2025

Estimated completion

01 Sep 2027

Severe Asthma

What is this study about?

If you live with severe asthma, you might know how challenging it can be to manage your symptoms. Researchers are always working to find new and more effective ways to help people like you. This particular study, called VALOUR, is focused on a potential new medicine named verekitug (UPB-101). It's a follow-up study for individuals who have already taken part in a previous asthma trial called VALIANT.

The main purpose of VALOUR is to carefully check the long-term safety and how well verekitug works over time. This is really important because medicines need to be both effective and safe for long-term use. By continuing to study participants from the VALIANT trial, researchers can gather more comprehensive information about this treatment. Understanding its effects over a longer period helps scientists make informed decisions about its potential as a future treatment option.

Taking part in studies like VALOUR is a vital step in medical progress. Your participation, along with others, contributes significantly to our understanding of severe asthma and the development of new ways to manage it, potentially improving the lives of many people in the future. Remember, this study is about research, and it's not a substitute for your regular medical care.

Key takeaways

Targets adults with severe asthma who completed a previous study (VALIANT).
Evaluates the long-term safety and effectiveness of verekitug (UPB-101).
Compares verekitug to a placebo.
Participation involves regular clinic visits and health checks.
Aims to gather more comprehensive data on this potential new treatment.
Your participation helps advance understanding and potential new therapies for severe asthma.

Who may be eligible?

This study is specifically for adults who have already completed a previous asthma study called VALIANT. To join VALOUR, you must have finished VALIANT exactly as planned and have given your written permission to participate in this long-term follow-up study.

There are also some general health requirements. You shouldn't have any other significant lung conditions apart from your asthma, like emphysema or bronchitis, that might interfere with the study results. Researchers will also check your medical history and test results to make sure it's safe for you to take part and that your health won't make it difficult to understand the study's findings.

Also, if you are pregnant, breastfeeding, or planning to become pregnant, or if you can become pregnant and are not willing to use effective birth control, this study would not be suitable for you. Finally, you need to be able to stick to the study's schedule of appointments and follow all instructions given by the study team.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have you completed the previous VALIANT asthma study?
Are you 18 years old or older?
Are you able to attend all study appointments?
Are you not pregnant, breastfeeding, or planning to become pregnant during the study?
Do you not have other serious lung conditions besides asthma?
Are you willing to discuss and use appropriate contraception if you can become pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, after giving your consent, you will continue to be monitored for the effects of verekitug or a placebo. This means you'll have regular visits to the clinic where the study team will conduct various assessments. These assessments will likely include physical examinations, blood tests, and tests to check your lung function (like how much air you can breathe in and out). You will be given either verekitug or a placebo, and the study team will provide all the necessary instructions on how and when to take your medication.

Your participation will also involve completing questionnaires about your asthma symptoms and how you are feeling generally. Throughout the study, the team will keep a close eye on your health and any changes you experience. The total duration of your participation will be explained to you by the study team, and it involves a commitment to attend all scheduled follow-up appointments.

Potential risks and benefits

Participating in a study like this could offer potential benefits, such as contributing valuable information that may help others with severe asthma in the future and receiving medical care and monitoring from a dedicated study team. However, there are also potential risks, including side effects from the study medication or the possibility that the treatment may not help your condition. All possible risks will be fully explained to you before you agree to take part. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (102)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Kern Research, Inc.
Verified postcode
Bakersfield, United States
California Medical Research Associates Inc.
Verified postcode
Northridge, United States
Integrated Research of Inland Inc
Verified postcode
Upland, United States
Allergy & Asthma Clinical Research
Verified postcode
Walnut Creek, United States
Allianz Research Institute
Verified postcode
Westminster, United States
Advance Pharma Research
Verified postcode
Cutler Bay, United States
Clinical Site Partners, LLC dba Flourish Research
Verified postcode
Miami, United States
Phoenix Medical Research
Verified postcode
Miami, United States
Research Institute of South Florida
Verified postcode
Miami, United States
Health and Life Research Institute, LLC
Verified postcode
Miami, United States
Nouvelle Clinical Research
Verified postcode
Miami, United States
Edward Jenner Research Group, LLC
Verified postcode
Plantation, United States

Common questions

What is verekitug (UPB-101)?

Verekitug (UPB-101) is a new medicine being investigated for its potential to treat severe asthma.

What is severe asthma?

Severe asthma is a type of asthma where symptoms are difficult to control even with standard treatments, often requiring higher doses of medication.

What does 'long-term safety and efficacy' mean?

It means the study is looking at how safe the medicine is and how well it works over an extended period of time.

What is a 'placebo'?

A placebo looks like the study medicine but contains no active ingredients. It's used to compare against the actual medicine.

Will I know if I'm getting verekitug or a placebo?

Typically, in this type of study, neither you nor the study team will know who is receiving the active drug and who is receiving the placebo until the study is over, to keep the results unbiased.