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

Conditions

• COPD Acute Exacerbation

Eligibility Criteria

Sex

ALL

Age

40 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

This is a Phase 2, multicenter study in adult participants with an acute COPD exacerbation and type 2 inflammation

Key Dates

Start date

Aug 12, 2025

Status verified

Apr 2026

Primary completion

Jun 30, 2026

Completion

Jul 31, 2026

Study Design

Enrollment

160 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Rademikibart
• Placebo Comparator: Placebo

Primary Outcome Measure

Treatment failure rate [ Time Frame: 28 days ]

Central Contacts

• Radha Adivikolanu
  213-522-7990
  [email protected]

Locations (22)

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