Imagine living with severe asthma, where a sudden flare-up can land you in the hospital. A study tested whether a new injectable medication called verekitug could help people with this condition breathe easier and have fewer of these scary episodes. The trial involved 479 adults with severe asthma. They were randomly assigned to receive either verekitug at different doses and schedules or a placebo (an inactive shot). Everyone received two injections at each visit to keep the study blind, meaning no one knew which treatment they were getting. The main goal was to see if verekitug could lower the annual rate of asthma exacerbations—those sudden worsening of symptoms that often require urgent care. The study also looked at other measures like lung function and overall asthma control, as well as the safety and side effects of the medication. The treatment period lasted up to 60 weeks, with follow-up continuing for about 16 weeks after the last dose. This research aimed to find out if this new approach could provide a meaningful benefit for people struggling to manage their severe asthma day to day.
Can a new injection help people with severe asthma breathe easier and avoid dangerous flare-ups?
Plain Language Summary
What this means for you:
A new injectable medication was tested to see if it reduces asthma attacks and improves breathing in severe asthma. What this means for you:
A new injectable medication was tested to see if it reduces asthma attacks and improves breathing in severe asthma. View Original Abstract ↓
Status: COMPLETED | Phase: PHASE2
Condition(s): Severe Asthma
Intervention(s): Verekitug (UPB-101) (DRUG), Placebo (DRUG)
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 incidence of asthma exacerbations, other pharmacodynamic (PD) parameters such as lung function and asthma control, and the safety and tolerability of verekitug (UPB-101) compared to placebo.
Detailed: This is a multicenter, randomized, placebo-controlled, parallel group study to assess the efficacy and safety of verekitug (UPB-101) administered subcutaneously (SC). A total of approximately 436 adult participants with severe asthma are planned for enrolment and will be randomized in a 1:1:1:1 ratio to receive verekitug (UPB-101) at doses of 100 mg every 12 weeks (Q12W), 400 mg every 24 weeks (Q24W), and 100 mg every 24 weeks (Q24W), or placebo administered SC. In order to maintain the blinding of different doses, all participants will receive 2 SC injections at each dosing visit. This study consists of a Screening/Run-In Period (approximately 4 weeks), Treatment Period (up to 60 weeks with a minimum of 24 weeks) and Follow-up Period (ending approximately 16 weeks after the last administr
Primary Outcome(s): Annual Asthma Exacerbation Rate (AAER)
Enrollment: 479 (ACTUAL)
Lead Sponsor: Upstream Bio Inc.
Start: 2024-02-27 | Primary Completion: 2025-12-16