← Back to Search

Other

Placebo for Asthma

Phase 2

Recruiting

Research Sponsored by Upstream Bio Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented treatment with a total daily dose of either medium or high dose inhaled corticosteroids (ICS) for at least 3 months. Participants on medium dose ICS must also have been taking at least one additional maintenance asthma controller medication for at least 3 months.

Documented history of asthma exacerbation(s) within 12 months of Visit 1.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 64

Awards & highlights

Study Summary

This trial is being conducted to see if verekitug (UPB-101) is effective and safe for people with severe asthma. The study will look at things like how often asthma attacks happen,

Who is the study for?

This trial is for adults aged 18-75 with severe asthma, who've had an exacerbation in the past year and are on medium to high dose inhalers plus another controller medication. They must have a certain level of asthma control and lung function, agree to use contraception, and be able to follow the study's procedures.Check my eligibility

What is being tested?

The VALIANT study tests Verekitug (UPB-101) against a placebo in severe asthma patients. It measures how well it prevents worsening of symptoms, improves lung function and overall control of asthma compared to not receiving the active drug.See study design

What are the potential side effects?

While specific side effects aren't listed here, typical ones may include reactions at injection sites, headaches, fatigue or allergic responses. The safety profile will compare any adverse effects experienced with Verekitug versus those observed with a placebo.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been on medium or high dose asthma inhalers for 3 months, and if on a medium dose, I've also used another asthma control medicine.

Select...

I have had an asthma attack in the last year.

Select...

I am between 18 and 75 years old.

Select...

I have been diagnosed with asthma for over a year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 64

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 64

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 64 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Annual Asthma Exacerbation Rate (AAER)

Secondary outcome measures

Change from Baseline in Asthma Control Questionnaire-6 (ACQ-6) to Week 60

Change from Baseline in Forced Expiratory Volume in 1 Second (FEV1) of Pre-bronchodilator (Pre-BD) to Week 60

Change from Baseline in Fractional exhaled nitric oxide (FeNO) to Week 60

+1 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Verekitug (UPB-101): 400 mg Q24W / PlaceboExperimental Treatment2 Interventions

Participants will receive 2.0 mL of verekitug (UPB-101) formulated solution (containing 400 mg of verekitug [UPB-101]) and 0.5 mL of placebo subcutaneously in two separate injections every 24 weeks up to Week 48. Participants will also receive 2 mL and 0.5 mL of placebo subcutaneously in two separate injections at Weeks 12 and 36 visits.

Group II: Verekitug (UPB-101): 100 mg Q24W / PlaceboExperimental Treatment2 Interventions

Participants will receive 0.5 mL of verekitug (UPB-101) formulated solution (containing 100 mg of verekitug [UPB-101]) and 2.0 mL of placebo subcutaneously in two separate injections every 24 weeks up to Week 48. Participants will also receive 2 mL and 0.5 mL of placebo subcutaneously in two separate injections at Weeks 12 and 36 visits.

Group III: Verekitug (UPB-101): 100 mg Q12W / PlaceboExperimental Treatment2 Interventions

Participants will receive 0.5 milliliter (mL) of verekitug (UPB-101) formulated solution (containing 100 milligrams [mg] of verekitug [UPB-101]) and 2.0 mL of placebo subcutaneously in two separate injections every 12 weeks up to Week 48.

Group IV: PlaceboPlacebo Group1 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 48.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Upstream Bio Inc.Lead Sponsor

3 Previous Clinical Trials

134 Total Patients Enrolled

1 Trials studying Asthma

32 Patients Enrolled for Asthma

James C Lee, MDStudy DirectorUpstream Bio

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there multiple Canadian medical facilities conducting this clinical trial?

"There are several medical facilities actively recruiting patients for this study. Some of these include Newport Native MD Inc in Newport Beach, Clinical Site Partners in Miami, and Clinical Site Partners operating as Flourish Research in Winter Park. Additionally, there are 7 other locations involved in patient recruitment."

Answered by AI

What is the current number of individuals receiving medical care as part of this clinical trial?

"To ensure the study's success, a total of 436 eligible participants are required. Upstream Bio Inc., the sponsor, will oversee operations at various sites including Newport Native MD Inc in Newport Beach, California and Clinical Site Partners in Miami, Maryland."

Answered by AI

Is this research study currently accepting new participants?

"Indeed, according to the data available on clinicaltrials.gov, this study is currently in the process of actively recruiting eligible candidates. The trial was initially posted on February 1st, 2024 and has since been edited most recently on January 22nd, 2024."

Answered by AI

Has the usage of placebo been officially sanctioned by the FDA?

"Based on our evaluation, the safety rating for the placebo in this Phase 2 trial is estimated to be a 2. Although there is some data supporting its safety, no evidence has been found regarding efficacy thus far."

Answered by AI

Are individuals who are 45 years of age or older eligible to participate in this study?

"To be eligible for enrollment in this clinical trial, individuals must meet the age requirement of being at least 18 years old but not exceeding 75 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALIANT)

2024. "A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALIANT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06196879.

All > High Point > Greensboro