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

Conditions

• Severe Asthma

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Verekitug (UPB-101) — DRUG
  Verekitug (UPB-101) formulated solution
• Placebo — DRUG
  Verekitug (UPB-101) matching placebo

Study Details

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.

Key Dates

First listed

Jan 9, 2024

Start date

Feb 27, 2024

Status verified

Apr 2026

Primary completion

Dec 16, 2025

Completion

Mar 19, 2026

Study Design

Enrollment

479 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Verekitug (UPB-101): 100 mg Q12W / Placebo
  Participants will receive 0.5 milliliter (mL) of verekitug (UPB-101) formulated solution (containing 100 milligrams \[mg\] of verekitug \[UPB-101\]) and 2.0 mL of placebo subcutaneously in two separate injections every 12 weeks up to Week 48.
• Experimental: Verekitug (UPB-101): 400 mg Q24W / Placebo
  Participants will receive 2.0 mL of verekitug (UPB-101) formulated solution (containing 400 mg of verekitug \[UPB-101\]) and 0.5 mL of placebo subcutaneously in two separate injections every 24 weeks up to Week 48. Participants will also receive 2 mL and 0.5 mL of placebo subcutaneously in two separate injections at Weeks 12 and 36 visits.
• Experimental: Verekitug (UPB-101): 100 mg Q24W / Placebo
  Participants will receive 0.5 mL of verekitug (UPB-101) formulated solution (containing 100 mg of verekitug \[UPB-101\]) and 2.0 mL of placebo subcutaneously in two separate injections every 24 weeks up to Week 48. Participants will also receive 2 mL and 0.5 mL of placebo subcutaneously in two separate injections at Weeks 12 and 36 visits.
• Placebo Comparator: Placebo
  Participants will receive 0.5 mL of matching placebo and 2.0 mL of matching placebo subcutaneously in two separate injections every 12 weeks up to Week 48.

Primary Outcome Measure

Annual Asthma Exacerbation Rate (AAER) [ Time Frame: Baseline up to Week 60 ]

Locations (55)

Find similar trials in Birmingham, AL

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