A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Rademikibart as an Add-on Treatment for Acute Exacerbation in Adult and Adolescent Participants With Asthma and Type 2 Inflammation
Connect Biopharm LLC
Summary
This is a Phase 2, randomized, multicenter study in adult and adolescent participants with asthma and type 2 inflammation
Description
This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, interventional trial in participants with an acute asthma exacerbation with type 2 inflammation to compare rademikibart plus standard therapy to standard therapy alone (plus placebo), targeting an acute asthma exacerbation in the urgent healthcare setting.
Eligibility
- Age range
- 12–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Physician-diagnosed asthma with duration of ≥12 months. * Currently receiving treatment with low, medium, to high dose ICS in combination with at least 1 additional asthma controller medication. * Must have experienced at least 1 asthma exacerbation requiring the use of systemic corticosteroids. * For participants in a stable condition, must have a documented historical peripheral blood eosinophil count of ≥250 cells/μL and/or FeNO ≥ 25 ppb. * Current acute asthma exacerbation requiring an urgent healthcare visit for treatment. * Peripheral blood eosinophil count of ≥300…
Interventions
- Combination ProductRademikibart in prefilled syringe
Participants receive 600 mg (4mL) of rademikibart administered subcutaneously.
- DrugMatching placebo in prefilled syringe
Participants receive 4mL of placebo matched to rademikibart administered subcutaneously.
Locations (52)
- Leland Stanford Junior University, Stanford HospitalPalo Alto, California
- Amicis Research CenterValencia, California
- Synergy HealthcareBradenton, Florida
- Pharmax Research of South Florida, Inc.Miami, Florida
- Columbus Clinical Services, LLCMiami, Florida
- Health Synergy Clinical Research, LLCWest Palm Beach, Florida