Clinical trial NCT06940154: Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD)
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Rademikibart as an Add-on Treatment for Acute Exacerbation in Participants With Chronic Obstructive Pulmonary Disease and Type 2 Inflammation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: COPD Acute Exacerbation
Keywords: COPD
chronic obstructive pulmonary disease
rademikibart
Connect Biopharma
CBP-201
COPD exacerbation
type 2 inflammation
Lead sponsor: Connect Biopharm LLC
Sponsor class: INDUSTRY
First posted: 2025-04-23
Enrollment: 160
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Treatment failure rate
timeFrame: 28 days
Secondary outcomes:
measure: Rate of new moderate and severe COPD exacerbations over the 28 days after randomization
timeFrame: 28 days
measure: Time to the first new moderate or severe COPD exacerbation in the 28 days after randomization
timeFrame: 28 days
measure: Mean change from baseline (CFB) in EXACT-PRO score
timeFrame: Week 1, Week 2, and Week 4
measure: Absolute CFB in post-BD FEV1 at Day 3, Week 1, and Week 4
timeFrame: Day 3, Week 1, and Week 4
measure: Incidence of adverse events (AEs), including serious adverse events (SAEs), adverse event of special interest (AESIs), and drug-induced liver injury (DILI) reported
timeFrame: 56 days
measure: Incidence of unanticipated adverse device effects (UADEs)
timeFrame: 56 days
measure: Incidence of injection site reactions
timeFrame: 56 days
Other outcomes:
Locations:
city: Bradenton
country: United States
facility: Synergy Healthcare
state: Florida
Study officials:
References: