VALIANT: Phase 2 trial of verekitug (UPB-101) for severe asthma completes enrollment of 479 patients
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Key Takeaway
Review the completed VALIANT phase 2 results for verekitug's effect on exacerbation rates in severe asthma.
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.
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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
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