NCT06196879

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

A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-ranging Study to Evaluate the Efficacy and Safety of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALIANT)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 479 (actual)
• Sponsor: Upstream Bio Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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 description

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 administration of study intervention).

Conditions

• Severe Asthma

Interventions

Type	Name	Description
DRUG	Verekitug (UPB-101)	Verekitug (UPB-101) formulated solution
DRUG	Placebo	Verekitug (UPB-101) matching placebo

Timeline

• Start date: 2024-02-27
• Primary completion: 2025-12-16
• Completion: 2026-03-19
• First posted: 2024-01-09
• Last updated: 2026-03-27

Locations

155 sites across 15 countries: United States, Argentina, Bulgaria, Canada, Chile, Czechia, Germany, Italy, Japan, Poland, South Africa, South Korea, Spain, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study