NCT06940154

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

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 Participants With Chronic Obstructive Pulmonary Disease and Type 2 Inflammation

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Connect Biopharm LLC · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, multicenter study in adult participants with an acute COPD exacerbation 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 COPD exacerbation with type 2 inflammation in the urgent healthcare setting to compare rademikibart plus standard therapy to standard therapy (plus placebo).

Conditions

• COPD Acute Exacerbation

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: 2025-08-12
• Primary completion: 2026-04-01
• Completion: 2026-05-01
• First posted: 2025-04-23
• Last updated: 2026-03-31

Locations

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

Regulatory

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