RecruitingPhase 2

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