Rademikibart Add-on Treatment of an acute Asthma Exacerbation (Seabreeze STAT Asthma)
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 Adult and Adolescent Participants With Asthma and Type 2 Inflammation
IRAS ID
1012084
Contact name
Jelane Hart
Contact email
Sponsor organisation
Connect Biopharm LLC (dba, Connect Biopharma)
Clinicaltrials.gov Identifier
Research summary
This study aims to find out how well a new medication (called rademikibart), when added to regular asthma treatment, can help prevent asthma from worsening during a serious asthma attack requiring urgent medical attention (including going to A&E, being admitted to hospital, visiting an urgent care centre, or going to a clinic that can quickly treat asthma attacks).
People aged 12 and older who have allergic asthma (a type of asthma with high levels of a white blood cell called eosinophils) will be invited to take part. Potential participants will be checked to see if they meet the study requirements (Screening) and can join the screening either when their asthma is stable (up to 26 weeks before an asthma attack happens), or at the time they are having an asthma attack. If participants qualify to take part, they will be randomly placed into one of two groups. One group will receive the study medication rademikibart, and the other will get 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 the study doctor will know which treatment they receive. This is called a “double-blind” study.
The study medication 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 while their asthma is stable, the study could last up to 34 weeks (up to 26 weeks screening, followed by 4 weeks of treatment monitoring and 4 weeks follow-up). If participants join while they are having an asthma attack, the study could last up to 8 weeks (up to 2 days screening, then 4 weeks of treatment monitoring and 4 weeks follow-up). During the study participants will be asked to give blood and urine samples, do breathing tests (spirometry, peak flow), have asthma symptoms checked and complete questionnaires.REC name
East Midlands - Derby Research Ethics Committee
REC reference
25/EM/0171
Date of REC Opinion
23 Sep 2025
REC opinion
Further Information Favourable Opinion