Asthma Acute study: Rademikibart
Official title Rademikibart IV for Acute Asthma and COPD Exacerbation
ClinicalTrials.gov ID: NCT07705737
What this study is testing
What is Rademikibart?
This is an investigational medicine being studied as an add-on treatment for acute asthma or COPD flare-ups.
Also referred to as CBP-201.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if adding rademikibart helps during acute asthma or COPD attacks.
- Who it's for
- Adults with asthma or COPD who experience a sudden flare and have type 2 inflammation.
- What's involved
- Participants receive IV rademikibart along with their regular treatment, and they will have visits and tests to monitor their condition.
- Time commitment
- The study lasts a few days and involves a few visits during the flare.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Asthma cohort
- Body weight of ≥40 kg and BMI ≤45 kg/m2 at SV1a.
- Physician-diagnosed asthma
- 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.
You likely can't join if
- Asthma cohort
- Regular use of immunosuppressive medication.
- Unstable ischemic heart disease, cardiomyopathy, heart failure, uncontrolled hypertension.
- Current or former smoker, with a smoking history of ≥5 pack-years if \<30 years old or ≥10 pack-years if ≥30 years old
- COPD and other clinically significant pulmonary disease other than asthma.
- Known or suspected history of immunosuppression.
See the full eligibility criteria
- Asthma cohort
- Body weight of ≥40 kg and BMI ≤45 kg/m2 at SV1a.
- Physician-diagnosed asthma
- 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.
- Participants in a stable condition, must have a 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.
- Asthma cohort
- Regular use of immunosuppressive medication.
- Unstable ischemic heart disease, cardiomyopathy, heart failure, uncontrolled hypertension.
- Current or former smoker, with a smoking history of ≥5 pack-years if \<30 years old or ≥10 pack-years if ≥30 years old
- 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 or other malignancies treated with apparent success with curative therapy.
- Female participant who is pregnant, lactating or breast-feeding.
- Recent receipt of any marketed nonbiologic drug that modulates type 2 cytokines.
- 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 receipt of any investigational nonbiologic drug.
- A recent chest X-ray or computed tomography with findings that are inconsistent for an asthmatic population. Inclusion Criteria - COPD cohort
- Body weight of ≥45 kg and BMI ≤45 kg/m2
- Physician-diagnosed COPD
- Must have experienced at least 1 COPD exacerbation requiring the use of systemic corticosteroids.
- Participants in a stable condition must have a historical peripheral blood eosinophil count of ≥250 cells/μL and/or FeNO ≥ 25 ppb.
- Current or former smoker with a history of smoking of ≥10 pack-years.
- Current acute COPD exacerbation requiring an urgent healthcare visit for treatment.
- Peripheral blood eosinophil count of ≥300 cells/μL as part of the assessment of the index acute COPD exacerbation.
- Requires systemic corticosteroids as standard of care treatment in the urgent healthcare setting for the current acute COPD exacerbation. Exclusion Criteria - COPD cohort
- Regular use of immunosuppressive medication 12 weeks or 5 half-lives prior to approximately 12 weeks or 5 half-lives, whichever is longer.
- Current diagnosis or a history of asthma, according to the Global Initiative for Asthma; or participants with a current diagnosis or history of Asthma COPD Overlap Syndrome.
- Other respiratory disorders that might compromise the safety of the participant or affect the interpretation of the results.
- Unstable ischemic heart disease, cardiomyopathy, heart failure, uncontrolled hypertension. Cardiac arrhythmias including paroxysmal atrial fibrillation.
- Transient ischemic attack or stroke \<6 months from Screening Visit; hospitalization for any cardiovascular or cerebrovascular event \<6 months from Screening Visit.
- 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.
- Chronic treatment with long-term oxygen therapy or nocturnal oxygen therapy required for \>15 hours a day.
- Participants on long-term macrolide.
- Current acute COPD exacerbation for which SoC was started \>48 hours prior to Screening.
- A recent chest X-ray or computed tomography scan reveals evidence of clinically significant abnormalities or pulmonary infection.
- Female participant who is pregnant, lactating or breast-feeding.
- Receipt of any marketed nonbiologic drug that modulates type 2 cytokines 30 days or 5 half-lives prior to SV1b, whichever is longer.
- Receipt of any marketed or any investigational biologic for COPD or other diseases within 16 weeks or 5 half-lives, whichever is longer.
- Live, attenuated vaccinations within 4 weeks prior to screening or planned live, attenuated vaccinations during the trial.
The study team makes the final eligibility decision.
Where it is enrolling
- Miami, Florida, United States
- St Louis, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Miami, Florida, United States; St Louis, Missouri, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.