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

NCT06940154 | Recruiting Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: CBP-201-207
• Study Type: interventional
• Target: 160
• Locations: 6 countries
• Sites: 51

Brief Summary

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

Conditions

COPD Acute Exacerbation

Keywords

COPD; chronic obstructive pulmonary disease; rademikibart; Connect Biopharma; CBP-201; COPD exacerbation; type 2 inflammation

Outcome Measures

Primary Outcomes (1)

• Treatment failure rate

  Treatment failure is defined as death due to any cause, (re)admission to a hospital for COPD, ED (re)visit or unscheduled medical visit for worsening of COPD symptoms, or the necessity to intensify pharmacologic treatment (including second course of systemic steroids for COPD exacerbation) within 28 days after randomization.

  28 days

Secondary Outcomes (7)

• Rate of new moderate and severe COPD exacerbations over the 28 days after randomization

  28 days

• Time to the first new moderate or severe COPD exacerbation in the 28 days after randomization

  28 days

• Mean change from baseline (CFB) in EXACT-PRO score

  Week 1, Week 2, and Week 4

• Absolute CFB in post-BD FEV1 at Day 3, Week 1, and Week 4

  Day 3, Week 1, and Week 4

• Incidence of adverse events (AEs), including serious adverse events (SAEs), adverse event of special interest (AESIs), and drug-induced liver injury (DILI) reported

  56 days

Study Arms (2)

Rademikibart

EXPERIMENTAL

Combination Product: Rademikibart in prefilled syringe

Placebo

PLACEBO COMPARATOR

Drug: Matching placebo in prefilled syringe

Interventions

Rademikibart in prefilled syringe COMBINATION_PRODUCT

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

Also known as: CBP-201

Rademikibart

Matching placebo in prefilled syringe DRUG

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

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Connect Biopharm LLC: lead

Study Sites (51)

University of Alabama at Birmingham Lung Health Center

Birmingham, Alabama, 35233, United States

RECRUITING

Leland Stanford Junior University, Stanford Hospital

Palo Alto, California, 94304, United States

RECRUITING

Amicis Research Center

Valencia, California, 91355, United States

RECRUITING

National Jewish Health

Denver, Colorado, 80206, United States

RECRUITING

Synergy Healthcare

Bradenton, Florida, 34209, United States

WITHDRAWN

Columbus Clinical Services, LLC

Miami, Florida, 33125, United States

RECRUITING

Pharmax Research of South Florida, Inc.

Miami, Florida, 33175, United States

RECRUITING

Health Synergy Clinical Research, LLC

West Palm Beach, Florida, 33407, United States

RECRUITING

Primeway Clinical Research Group

Fayetteville, Georgia, 30214, United States

RECRUITING

Pivotal Research Solutions

Stonecrest, Georgia, 30038, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Ochsner Medical Complex - The Grove

Baton Rouge, Louisiana, 70836, United States

RECRUITING

Stony Brook University Hospital

Stony Brook, New York, 11733, United States

RECRUITING

Duke Asthma, Allergy, and Airway Center

Durham, North Carolina, 27705, United States

RECRUITING

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

Clinical Research of Rock Hill

Rock Hill, South Carolina, 29732, United States

RECRUITING

Inquest Clinical Research

Baytown, Texas, 77521, United States

RECRUITING

Premier Pulmonary Critical Care and Sleep Medicine

Denison, Texas, 75020, United States

RECRUITING

DCT- McAllen Primary Care Research, LLC dba Discovery Clinical Trials

McAllen, Texas, 78503, United States

RECRUITING

Vermont Lung Center

Colchester, Vermont, 05446, United States

NOT YET RECRUITING

Carilion Medical Center / Carilion Roanoke Memorial Hospital

Roanoke, Virginia, 24014, United States

RECRUITING

Hospital Italiano de Buenos Aires

CABA, Buenos Aires, C1199, Argentina

RECRUITING

CEMER - Centro Medico de Enfermedades Respiratorias

Florida, Buenos Aires, B1602, Argentina

RECRUITING

Instituto Ave Pulmo-Fundacion Enfisema

Mar del Plata, Buenos Aires, 7600, Argentina

RECRUITING

Centro de Investigaciones Médicas Mar del Plata

Mar del Plata, Buenos Aires, B7600FYK, Argentina

RECRUITING

Hospital Universitario Austral

Pilar, Buenos Aires, 1629, Argentina

RECRUITING

Centro Medico Ipam S.A

Rosario, Santa Fe Province, S2000, Argentina

NOT YET RECRUITING

Investigaciones en Patologias Respiratorias SRL

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

RECRUITING

Centro de Diagnostivo y Rehabilitación S.A. - CEDIR

Santa Fe, S3000, Argentina

RECRUITING

The Canberra Hospital

Garran, Australian Capital Territory, 2605, Australia

RECRUITING

St. Vincent's Hospital Sydney

Darlinghurst, New South Wales, 2010, Australia

RECRUITING

Westmead Hospital

Westmead, New South Wales, 2145, Australia

RECRUITING

Sunshine Coast University Hospital

Birtinya, Queensland, 4575, Australia

RECRUITING

Institute for Respiratory Health

Nedlands, Western Australia, 6009, Australia

RECRUITING

JSC "National Center for Lung Health"

Tbilisi, 0101, Georgia

RECRUITING

LLC "Israel-Georgian Medical Research Clinic Healthycore"

Tbilisi, 0112, Georgia

RECRUITING

Acad. Chapidze Emergency Cardiology Center LLC

Tbilisi, 0159, Georgia

RECRUITING

Acad. G. Chapidze Emergency Cardiology Center

Tbilisi, 0159, Georgia

RECRUITING

Caucasus Medical Center

Tbilisi, 0159, Georgia

RECRUITING

LLC Diacor

Tbilisi, 0159, Georgia

RECRUITING

Clinical Hospital Center "Dragisa Misovic - Dedinje"

Belgrade, 11040, Serbia

RECRUITING

Institute for Pulmonary Diseases of Vojvodina

Kamenitz, 21204, Serbia

RECRUITING

University Clinical Center Kragujevac

Kragujevac, 34000, Serbia

RECRUITING

Institute for Pulmonary Diseases and Tuberculosis Nis

Niš, 18108, Serbia

RECRUITING

Health Center Uzice

Užice, 31000, Serbia

RECRUITING

Medicines Evaluation Unit Ltd.

Wythenshawe, Greater Manchester, M23 9QZ, United Kingdom

RECRUITING

Queen Elizabeth hospital Birmingham

Birmingham, B15 2GW, United Kingdom

RECRUITING

University Hospitals Birmingham NHS Foundation Trust Birmingham Heartlands Hospital

Birmingham, B9 5SS, United Kingdom

RECRUITING

Guy's and St Thomas NHS Foundation Trust

London, SE1 7EH, United Kingdom

RECRUITING

Salford Royal Hospital - Northern Care Alliance NHS Foundation Trust Barnes Clinical Research Facility

Salford, M6 8HD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Radha Adivikolanu

CONTACT

213-522-7990; clinical207@connectpharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 23, 2025
• Study Start: August 12, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (22); GE (6); AR (8); SE (5); AU (5); GB (5)