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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-12

Study Completion Date

2026-05-31

Brief Summary

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

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Detailed Description

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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).

Conditions

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COPD Acute Exacerbation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Rademikibart

Group Type EXPERIMENTAL

Rademikibart in prefilled syringe

Intervention Type COMBINATION_PRODUCT

Participants receive 600 mg (4mL) of rademikibart administered subcutaneously.

Placebo

Group Type PLACEBO_COMPARATOR

Matching placebo in prefilled syringe

Intervention Type DRUG

Participants receive 4mL of placebo matched to rademikibart administered subcutaneously.

Interventions

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Rademikibart in prefilled syringe

Participants receive 600 mg (4mL) of rademikibart administered subcutaneously.

Intervention Type COMBINATION_PRODUCT

Matching placebo in prefilled syringe

Participants receive 4mL of placebo matched to rademikibart administered subcutaneously.

Intervention Type DRUG

Other Intervention Names

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CBP-201

Eligibility Criteria

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Inclusion Criteria

* Physician-diagnosed COPD with duration of ≥12 months.
* Must have experienced at least 1 COPD exacerbation requiring the use of systemic corticosteroids.
* Participants in a stable condition must have a documented 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

* 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 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 (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.
* A recent 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).
* 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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No