Rademikibart IV for Acute Asthma and COPD Exacerbation
A Phase 2, Open-Label, Single-Arm Trial to Evaluate IV Rademikibart as an Add-on Treatment for Acute Exacerbation in Participants With Asthma and or COPD With Type 2 Inflammation
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 85 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests rademikibart given through a vein (IV), along with usual treatment, for a sudden asthma or COPD flare-up. It is for people with type 2 inflammation, a kind of immune response. COPD is a lung disease that makes breathing hard.
A Phase 2, open-label, single-arm trial to evaluate IV rademikibart as an add-on treatment for acute exacerbation in participants with asthma or COPD with type 2 inflammation
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Both groups: Have asthma or COPD diagnosed by a doctor, with a current flare-up needing an urgent healthcare visit and steroid medicine that treats the whole body.
- Both groups: Have had at least one earlier flare-up that needed steroid medicine that treats the whole body.
- Both groups: When stable, have a past blood eosinophil count of at least 250 cells/μL or a breath FeNO level of at least 25 ppb. These tests measure signs of inflammation.
- Both groups: During the current flare-up, have at least 300 eosinophils per μL of blood. Eosinophils are a type of white blood cell.
- Asthma group: Weigh at least 40 kg. COPD group: Weigh at least 45 kg. Both groups need a BMI of 45 or less. BMI compares weight with height.
- Asthma group: Use an inhaled steroid plus at least one other medicine to control asthma.
- Asthma group: Have an FEV1 breathing test result of at least 30% of the expected value. This measures how much air you can blow out in one second.
- COPD group: Currently smoke or used to smoke, with at least 10 pack-years of smoking. One pack-year means smoking one pack a day for one year.
Who can't join
- Both groups: Regular use of medicines that weaken the immune system; a known or suspected weakened immune system; an immune deficiency disorder; hepatitis B or C; or a history of alcohol or drug abuse.
- Both groups: Certain serious heart problems or uncontrolled high blood pressure. COPD group: Also certain uneven heartbeats, or a stroke, mini-stroke, or hospital stay for a heart or brain blood vessel event within 6 months.
- Both groups: Pregnancy or breastfeeding, or a recent history of cancer. Some skin or early cervical cancers are allowed; the asthma group also allows other cancers treated with apparent success.
- Asthma group: COPD or another major lung disease, or smoking of at least 5 pack-years if under age 30, or 10 pack-years if age 30 or older. COPD group: Current or past asthma, asthma-COPD overlap, or another breathing disorder that could affect safety or results.
- Both groups: Recent use of certain medicines that target type 2 inflammation or biologic medicines, which act on the immune system. COPD rules include waiting periods of at least 30 days or 16 weeks, depending on the medicine, and sometimes longer.
- Both groups: Recent live, weakened vaccines or plans to get them during the study. COPD group: This includes vaccines within 4 weeks before screening. Asthma group: Also recent experimental nonbiologic drugs or bronchial thermoplasty, a heat treatment for asthma.
- COPD group: Long-term oxygen needed more than 15 hours a day, long-term macrolide antibiotics, or usual treatment for the current flare-up started more than 48 hours before screening.
- Both groups: Certain abnormal chest X-ray or CT scan findings. For COPD, this includes major abnormalities or a lung infection.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion 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. Exclusion Criteria - 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 above inclusion and exclusion criteria are not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study sites (2)
FL
- Columbus Clinical Services, LLC · Miami, FL 33135Radha Adivikolanu · Study contact · 213-522-7990 · clinical209@connectpharm.comMore trials in Miami
- Pharmax Research of South Florida, Inc. · Miami, FL 33175Radha Adivikolanu · Study contact · 213-522-7990 · clinical209@connectpharm.comMore trials in Miami