Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD)

Connect Biopharm LLC

Status and phase

Enrolling

Phase 2

Conditions

COPD Acute Exacerbation

Treatments

Combination Product: Rademikibart in prefilled syringe

Drug: Matching placebo in prefilled syringe

Study type

Interventional

Funder types

Industry

Identifiers

NCT06940154

CBP-201-207

Details and patient eligibility

About

This is a Phase 2, multicenter study in adult participants with an acute COPD exacerbation and type 2 inflammation

Full description

This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, interventional trial in participants with an acute COPD exacerbation with type 2 inflammation in the urgent healthcare setting to compare rademikibart plus standard therapy to standard therapy (plus placebo).

Enrollment

160 estimated patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Physician-diagnosed COPD with duration of ≥12 months.
Must have experienced at least 1 COPD exacerbation requiring the use of systemic corticosteroids (oral or parenteral) within the previous 12 months prior to Screening.
Participants who consent to participate in the trial while in a stable condition must have a documented historical peripheral blood eosinophil count of ≥250 cells/μL within 12 months prior to Screening Visit 1a.
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

Regular use of immunosuppressive medication 12 weeks or 5 half-lives prior to randomization, 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 (New York Heart Association Class III or IV), 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 (including human immunodeficiency virus [HIV]-1 or HIV-2). Known medical history of hepatitis B or C.
History of alcohol abuse and/or drug abuse within 12 months prior to Screening.
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 (LTOT) 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.
Chest X-ray or computed tomography (CT) scan at Screening reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD, or a clinically significant pulmonary infection identified by chest X-ray (CT scan) at Screening Visit 1b.
Female participant who is pregnant, lactating or breast-feeding, or has a positive urinary β-hCG test prior to randomization.
Receipt of any marketed nonbiologic drug that modulates type 2 cytokines 30 days or 5 half-lives prior to randomization, whichever is longer.
Receipt of any marketed or any investigational biologic for COPD or other diseases within 16 weeks or 5 half-lives prior to randomization, whichever is longer.
Live, attenuated vaccinations within 4 weeks prior to randomization or planned live, attenuated vaccinations during the trial.
Treatment with oral corticosteroids and/or hospitalization for an exacerbation of COPD completed less than 4 weeks prior to randomization.

The above inclusion and exclusion criteria are not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.