Rademikibart IV for Acute Asthma and COPD Exacerbation

Official title

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

Overview

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

Detailed description

A phase 2, open-label, single-arm trial to assess the efficacy of a single 300 mg dose of rademikibart administered as a 2-minute IV infusion (IV push) on lung function in participants with asthma or COPD with type 2 inflammation who require an urgent healthcare visit for the treatment of acute exacerbation.

Interventions

• Drug Rademikibart
  Single 300 mg dose as a 2-minute IV push

Primary outcome measures

• Change from baseline in post-BD FEV1 [Time frame: 1 week]

Secondary outcome measures (2)

• Change from baseline in post-BD FEV1 at scheduled timepoints [Time frame: Days 1, 2, 3, 14, 28, and 42]
• Incidence of treatment-emergent adverse events [Time frame: 42 days]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Columbus Clinical Services, LLC — Miami

Identifiers

NCT: NCT07705737 · CBP-201-209

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗