Rademikibart IV for Acute Asthma and COPD Exacerbation

Connect Biopharm LLC

Status and phase

Not yet enrolling

Phase 2

Conditions

COPD Exacerbation Acute

Asthma Acute

Treatments

Drug: Rademikibart

Study type

Interventional

Funder types

Industry

Identifiers

NCT07705737

CBP-201-209

Details and patient eligibility

About

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

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.