VALIANT: Phase 2 trial of verekitug (UPB-101) for severe asthma completes enrollment of 479 patients

The VALIANT study was a multicenter, randomized, placebo-controlled, parallel-group phase 2 trial designed to evaluate the efficacy and safety of subcutaneous verekitug (UPB-101) in adult participants with severe asthma. The study planned to enroll approximately 436 participants but ultimately enrolled 479. Participants were randomized in a 1:1:1:1 ratio to receive one of three verekitug dosing regimens—100 mg every 12 weeks (Q12W), 400 mg every 24 weeks (Q24W), or 100 mg every 24 weeks (Q24W)—or matching placebo. To maintain blinding, all participants received two subcutaneous injections at each dosing visit. The study consisted of a Screening/Run-In Period of approximately 4 weeks, a Treatment Period of up to 60 weeks (with a minimum of 24 weeks), and a Follow-up Period ending approximately 16 weeks after the last administration. The primary efficacy outcome was the Annual Asthma Exacerbation Rate (AAER). Other pharmacodynamic parameters assessed included lung function and asthma control. The study also evaluated the safety and tolerability of verekitug compared to placebo. The study was sponsored by Upstream Bio Inc., started on February 27, 2024, and had a primary completion date of December 16, 2025. The abstract status is listed as COMPLETED.

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.