Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD)
Research type
Research Study
Full title
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
IRAS ID
1012083
Contact name
Jelane Hart
Contact email
Sponsor organisation
Connect Biopharm LLC (dba, Connect Biopharma)
Clinicaltrials.gov Identifier
Research summary
This study aims find out how well a new medication (rademikibart), when added to regular COPD treatment, can help prevent COPD from getting worse during a serious flare-up requiring urgent medical attention (e.g. an A&E or urgent care centre visit, being admitted to the hospital, or going to a clinic that can quickly treat COPD flare-ups).
People aged 40-80 years who have a type of COPD with high levels of a white blood cell called eosinophils, may be able to take part. Potential participants will be checked to see if they meet the study requirements (Screening). Participants can join the screening either when their COPD is stable (up to 26 weeks before a severe flare-up happens), or at the time they are having a severe flare-up.
If a participant qualifies for the study, they will be randomly placed into one of two groups. One group will receive the study medication rademikibart, and the other a placebo (which looks like the study drug but doesn’t have any medicine in it). This is done by chance — like flipping a coin — and participants have an equal (50/50) chance of getting either one. Neither the participant nor their study doctor will know which treatment they receive. This is called a “double-blind” study.
Rademikibart or placebo will be given as four injections under the skin at the same time. How long participants are in the study depends on when they join. If participants join whilst their COPD is stable, the study could last up to 34 weeks, including up to 26 weeks screening, followed by 4 weeks of treatment monitoring and 4 weeks follow-up. If participants join while they are having a COPD flare-up, the study could last up to 8 weeks, including up to 2 days of screening, then 4 weeks of treatment monitoring and 4 weeks follow-up.
During treatment and follow-up, participants will be asked to give blood and urine samples, do breathing tests (e.g. spirometry), have their COPD symptoms checked, and complete questionnaires about symptoms and healthcare use.REC name
London - Surrey Borders Research Ethics Committee
REC reference
25/LO/0530
Date of REC Opinion
27 Aug 2025
REC opinion
Further Information Favourable Opinion