RECRUITINGPhase 2INTERVENTIONAL
Rademikibart Add-on Treatment of an Acute Asthma Exacerbation (Seabreeze STAT Asthma)
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
About This Trial
This is a Phase 2, randomized, multicenter study in adult and adolescent participants with asthma and type 2 inflammation
Who May Be Eligible (Plain English)
Who May Qualify:
- Physician-diagnosed asthma with duration of ≥12 months.
- Currently receiving treatment with low, medium, to high dose ICS in combination with at least 1 additional asthma controller medication.
- Must have experienced at least 1 asthma exacerbation requiring the use of systemic corticosteroids.
- For participants in a stable condition, must have a documented historical peripheral blood eosinophil count of ≥250 cells/μL and/or FeNO ≥ 25 ppb.
- Current acute asthma exacerbation requiring an urgent healthcare visit for treatment.
- Peripheral blood eosinophil count of ≥300 cells/µL as part of the assessment of an index acute asthma exacerbation.
- Requires systemic corticosteroid as SoC in the urgent healthcare setting to treat the current acute asthma exacerbation.
- FEV1 ≥30% predicted.
Who Should NOT Join This Trial:
- Regular use of immunosuppressive medication.
- Unstable ischemic heart disease, cardiomyopathy, heart failure, uncontrolled hypertension.
- Current or former smoker, has a smoking history including: If \<30 years old: Smoked for ≥5 pack-years; If ≥30 years old: Smoked for ≥10 pack-years
- COPD and other clinically significant pulmonary disease other than asthma.
- Known or suspected history of immunosuppression.
- History of known weakened immune system disorder or hepatitis B or C.
- History of alcohol abuse and/or drug abuse.
- Recent history of cancer except basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy or other malignancies treated with apparent success with curative therapy.
- Female participant who is pregnant, lactating or breast-feeding, or has a positive urinary β hCG test prior to randomization.
- Recent receipt of any marketed nonbiologic drug that modulates type 2 cytokines (eg, suplatast tosilate).
- Recent receipt of any marketed biologic drug or any investigational biologic for asthma or other diseases.
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Physician-diagnosed asthma with duration of ≥12 months.
* Currently receiving treatment with low, medium, to high dose ICS in combination with at least 1 additional asthma controller medication.
* Must have experienced at least 1 asthma exacerbation requiring the use of systemic corticosteroids.
* For participants in a stable condition, must have a documented historical peripheral blood eosinophil count of ≥250 cells/μL and/or FeNO ≥ 25 ppb.
* Current acute asthma exacerbation requiring an urgent healthcare visit for treatment.
* Peripheral blood eosinophil count of ≥300 cells/µL as part of the assessment of an index acute asthma exacerbation.
* Requires systemic corticosteroid as SoC in the urgent healthcare setting to treat the current acute asthma exacerbation.
* FEV1 ≥30% predicted.
Exclusion Criteria:
* Regular use of immunosuppressive medication.
* Unstable ischemic heart disease, cardiomyopathy, heart failure, uncontrolled hypertension.
* Current or former smoker, has a smoking history including: If \<30 years old: Smoked for ≥5 pack-years; If ≥30 years old: Smoked for ≥10 pack-years
* COPD and other clinically significant pulmonary disease other than asthma.
* Known or suspected history of immunosuppression.
* History of known immunodeficiency disorder or hepatitis B or C.
* History of alcohol abuse and/or drug abuse.
* Recent history of cancer except basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy or other malignancies treated with apparent success with curative therapy.
* Female participant who is pregnant, lactating or breast-feeding, or has a positive urinary β hCG test prior to randomization.
* Recent receipt of any marketed nonbiologic drug that modulates type 2 cytokines (eg, suplatast tosilate).
* Recent receipt of any marketed biologic drug or any investigational biologic for asthma or other diseases.
* Recent live, attenuated vaccinations or planned live, attenuated vaccinations during the trial.
* Participants that have been recently treated with bronchial thermoplasty.
* Recent treatment with OCS and/or hospitalization for an exacerbation of asthma.
* Recent receipt of any investigational nonbiologic drug.
* A recent chest X-ray or computed tomography (CT) with findings that are inconsistent for an asthmatic population.
The above inclusion and exclusion criteria are not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Treatments Being Tested
COMBINATION_PRODUCT
Rademikibart in prefilled syringe
Participants receive 600 mg (4mL) of rademikibart administered subcutaneously.
DRUG
Matching placebo in prefilled syringe
Participants receive 4mL of placebo matched to rademikibart administered subcutaneously.
Locations (20)
Amicis Research Center
Valencia, California, United States
Synergy Healthcare
Bradenton, Florida, United States
Pharmax Research of South Florida, Inc.
Miami, Florida, United States
Columbus Clinical Services, LLC
Miami, Florida, United States
Health Synergy Clinical Research, LLC
West Palm Beach, Florida, United States
Primeway Clinical Research Group
Fayetteville, Georgia, United States
Pivotal Research Solutions
Stonecrest, Georgia, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Allergy & Asthma Specialists, P.S.C.
Owensboro, Kentucky, United States
Chesapeake Clinical Research, Inc.
White Marsh, Maryland, United States
Washington University School of Medicine
St Louis, Missouri, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Clinical Research of Rock Hill
Rock Hill, South Carolina, United States
Inquest Clinical Research
Baytown, Texas, United States
Premier Pulmonary Critical Care and Sleep Medicine
Denison, Texas, United States
DCT- McAllen Primary Care Research, LLC dba Discovery Clinical Trials
McAllen, Texas, United States
STAT Research
Caba, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
Caba, Buenos Aires, Argentina
Investigaciones en Alergias y Enfermoedades Respiratorias (InAER)
Caba, Buenos Aires, Argentina