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NCT06940154 | RECRUITING | COPD Acute Exacerbation

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

Connect Biopharm LLC

Brief Summary:

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

Condition or disease

COPD Acute Exacerbation

Intervention/treatment

Rademikibart in prefilled syringe

Matching placebo in prefilled syringe

Phase

PHASE2

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).

Study Type : INTERVENTIONAL
Estimated Enrollment : 160 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2025-05
Estimated Primary Completion Date : 2026-04
Estimated Study Completion Date : 2026-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD)

Location Details

NCT06940154

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

Synergy Healthcare

Bradenton, Florida, United States, 34209