Connect Biopharma announced the initiation of its Phase 2 Seabreeze STAT COPD study (NCT06940154), following written agreement on the final study protocol from the U.S. Food and Drug Administration. This study will evaluate rademikibart as an adjunct to standard of care for acute exacerbations in participants with COPD and type 2 inflammation.
The study is expected to enroll approximately 160 participants globally who have an acute COPD exacerbation and type 2 inflammation. Participants will receive either a single dose of rademikibart or placebo, administered subcutaneously.
The primary endpoint is the safety and efficacy of rademikibart as an adjunct to standard of care, measured by the treatment failure rate over 28 days following an acute exacerbation. Topline data from this study are expected in the first half of 2026.
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