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)
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)
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.
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).
Inclusion Criteria:
Exclusion Criteria:
San Juan Bautista, Buenos Aires 1888, Argentina
San Miguel de Tucumán, Tucumán Province CP T4000IAP, Argentina
Caba, C1121ABE, Argentina
CABA, C1425BEN, Argentina
Rousse, 7000, Bulgaria
Chuo-ku, Tokyo 103-0027, Japan
Chuo-ku, Tokyo 104-0031, Japan
Wroclaw, Dolnoslaskie Voivodeship 53-201, Poland
Tarnów, Malopolskie Voivodeship 33-100, Poland
Gdansk, Pomorskie Voivodeship 80-214, Poland
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship 27-400, Poland
Seoul, Republic of Korea 06591, South Korea
Ivano-Frankivsk, 76018, Ukraine
Birmingham, West Midlands B9 5SS, United Kingdom