NCT06940141

Rademikibart Add-on Treatment of an Acute Asthma Exacerbation (Seabreeze STAT Asthma)

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Connect Biopharm LLC · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, randomized, multicenter study in adult and adolescent participants with asthma and type 2 inflammation

Detailed 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.

Conditions

• Asthma Acute

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Rademikibart in prefilled syringe	Participants receive 600 mg (4mL) of rademikibart administered subcutaneously.
DRUG	Matching placebo in prefilled syringe	Participants receive 4mL of placebo matched to rademikibart administered subcutaneously.

Timeline

• Start date: 2025-08-08
• Primary completion: 2026-04-01
• Completion: 2026-05-01
• First posted: 2025-04-23
• Last updated: 2026-03-31

Locations

49 sites across 6 countries: United States, Argentina, Australia, Georgia, Serbia, United Kingdom

Regulatory

• FDA-regulated drug study
• FDA-regulated device study