Actively Recruiting

Phase 2
Age: 12Years - 75Years
All Genders
NCT06940141

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

Led by Connect Biopharm LLC · Updated on 2026-04-27

160

Participants Needed

52

Research Sites

46 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a Phase 2, randomized, multicenter study in adult and adolescent participants with asthma and type 2 inflammation

CONDITIONS

Official Title

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

Who Can Participate

Age: 12Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Physician-diagnosed asthma with duration of �3e�3d 12 months.
  • Currently receiving low, medium, or high dose inhaled corticosteroids combined with at least one additional asthma controller medication.
  • History of at least one asthma exacerbation requiring systemic corticosteroids.
  • For stable participants, documented peripheral blood eosinophil count �3e�3d 250 cells/bcL and/or FeNO �3e�3d 25 ppb.
  • Current acute asthma exacerbation needing urgent healthcare treatment.
  • Peripheral blood eosinophil count �3e�3d 300 cells/bcL at the time of the acute exacerbation assessment.
  • Requires systemic corticosteroid treatment as standard of care during urgent healthcare visit.
  • Forced expiratory volume in 1 second (FEV1) �3e�3d 30% predicted.
Not Eligible

You will not qualify if you...

  • Regular use of immunosuppressive medication.
  • Unstable ischemic heart disease, cardiomyopathy, heart failure, or uncontrolled hypertension.
  • Current or former smoker with smoking history: under 30 years old with �3e�3d 5 pack-years; 30 years or older with �3e�3d 10 pack-years.
  • Chronic obstructive pulmonary disease (COPD) or other significant lung diseases besides asthma.
  • Known or suspected immunosuppression.
  • History of immunodeficiency disorder or hepatitis B or C.
  • History of alcohol or drug abuse.
  • Recent history of cancer except certain successfully treated cancers like basal cell carcinoma or in situ cervical carcinoma.
  • Female participants who are pregnant, breastfeeding, or have a positive pregnancy test before randomization.
  • Recent use of drugs modulating type 2 cytokines or biologic drugs for asthma or other diseases.
  • Recent live attenuated vaccinations or planned live vaccines during the trial.
  • Recent treatment with bronchial thermoplasty.
  • Recent use of oral corticosteroids or hospitalization for asthma exacerbation.
  • Recent participation in investigational drug studies.
  • Recent chest X-ray or CT scan findings inconsistent with asthma.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 52 locations

1

Leland Stanford Junior University, Stanford Hospital

Palo Alto, California, United States, 94304

Actively Recruiting

2

Amicis Research Center

Valencia, California, United States, 91355

Actively Recruiting

3

Synergy Healthcare

Bradenton, Florida, United States, 34209

Withdrawn

4

Pharmax Research of South Florida, Inc.

Miami, Florida, United States, 33175

Actively Recruiting

5

Columbus Clinical Services, LLC

Miami, Florida, United States, 33215

Actively Recruiting

6

Health Synergy Clinical Research, LLC

West Palm Beach, Florida, United States, 33407

Actively Recruiting

7

Primeway Clinical Research Group

Fayetteville, Georgia, United States, 30214

Actively Recruiting

8

Pivotal Research Solutions

Stonecrest, Georgia, United States, 30038

Actively Recruiting

9

University of Iowa

Iowa City, Iowa, United States, 52242

Actively Recruiting

10

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

Actively Recruiting

11

Allergy & Asthma Specialists, P.S.C.

Owensboro, Kentucky, United States, 42301

Actively Recruiting

12

Chesapeake Clinical Research, Inc.

White Marsh, Maryland, United States, 21162

Actively Recruiting

13

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

14

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States, 43210

Actively Recruiting

15

Clinical Research of Rock Hill

Rock Hill, South Carolina, United States, 29732

Actively Recruiting

16

Inquest Clinical Research

Baytown, Texas, United States, 77521

Actively Recruiting

17

Premier Pulmonary Critical Care and Sleep Medicine

Denison, Texas, United States, 75020

Actively Recruiting

18

DCT- McAllen Primary Care Research, LLC dba Discovery Clinical Trials

McAllen, Texas, United States, 78503

Actively Recruiting

19

STAT Research

Caba, Buenos Aires, Argentina, C1023

Actively Recruiting

20

Hospital Italiano de Buenos Aires

Caba, Buenos Aires, Argentina, C1199

Actively Recruiting

21

Investigaciones en Alergias y Enfermoedades Respiratorias (InAER)

Caba, Buenos Aires, Argentina, C1425BEN

Actively Recruiting

22

Instituto Ave Pulmo-Fundacion Enfisema

Mar del Plata, Buenos Aires, Argentina, 7600

Actively Recruiting

23

Centro respiratorio Infantil

Rosario, Santa Fe Province, Argentina, 2000

Actively Recruiting

24

INECO Neurociencias Oroño

Rosario, Santa Fe Province, Argentina, S2000

Actively Recruiting

25

Investigaciones en Patologias Respiratorias SRL

San Miguel de Tucumán, Tucumán Province, Argentina, 4000

Actively Recruiting

26

INSARES

Mendoza, Argentina, 5500CCG

Actively Recruiting

27

Centro de Diagnostico y Rehabilitación S.A. -CEDIR

Santa Fe, Argentina, S3000

Not Yet Recruiting

28

The Canberra Hospital

Garran, Australian Capital Territory, Australia, 2605

Actively Recruiting

29

St. Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia, 2010

Actively Recruiting

30

St George Hospital, South Eastern Sydney Local Health District

Kogarah, New South Wales, Australia, 2217

Actively Recruiting

31

Queensland Children's Hospital

South Brisbane, Queensland, Australia, 4101

Actively Recruiting

32

Bendigo Health

Bendigo, Victoria, Australia, 3550

Actively Recruiting

33

JSC "National Center for Lung Health"

Tbilisi, Georgia, 0101

Actively Recruiting

34

LLC "Israel-Georgian Medical Research Clinic Healthycore"

Tbilisi, Georgia, 0112

Actively Recruiting

35

Acad. Chapidze Emergency Cardiology Center LLC

Tbilisi, Georgia, 0159

Actively Recruiting

36

Caucasus Medical Center

Tbilisi, Georgia, 0159

Actively Recruiting

37

LLC Diacor

Tbilisi, Georgia, 0159

Actively Recruiting

38

Raymann, LLC

Tbilisi, Georgia, 0186

Actively Recruiting

39

Clinical Hospital Center "Dragisa Misovic - Dedinje"

Belgrade, Serbia, 11040

Actively Recruiting

40

Clinical Hospital Center Zemun

Belgrade, Serbia, 11080

Not Yet Recruiting

41

Institute for Pulmonary Diseases of Vojvodina

Kamenitz, Serbia, 21204

Actively Recruiting

42

University Clinical Center Kragujevac

Kragujevac, Serbia, 34000

Actively Recruiting

43

Institute for Pulmonary Diseases and Tuberculosis Nis

Niš, Serbia, 18108

Actively Recruiting

44

Health Center Uzice

Užice, Serbia, 31000

Actively Recruiting

45

Salford Royal Hospital - Northern Care Alliance NHS Foundation Trust Barnes Clinical Research Facility

Salford, Greater Manchester, United Kingdom, M6 8HD

Actively Recruiting

46

Medicines Evaluation Unit Ltd.

Wythenshawe, Greater Manchester, United Kingdom, M23 9QZ

Actively Recruiting

47

Norfolk and Norwich University Hospital NHS Foundation Trust

Norwich, Norfolk, United Kingdom, NR4 7UY

Actively Recruiting

48

University Hospitals Birmingham NHS Foundation Trust of Trust Headquarters Queen Elizabeth hospital Birmingham

Birmingham, United Kingdom, B15 2GW

Actively Recruiting

49

University Hospitals Birmingham NHS Foundation Trust Birmingham Heartlands Hospital

Birmingham, United Kingdom, B9 5SS

Actively Recruiting

50

Bradford Teaching Hospitals NHS Foundation Trust

Bradford, United Kingdom, BD96RJ

Actively Recruiting

51

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom, SE1 7EH

Actively Recruiting

52

Kings College Hospital NHS Foundation

London, United Kingdom, SE5 9RS

Actively Recruiting

Loading map...

Research Team

R

Radha Adivikolanu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here