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New shot aims to tame COPD Flare-Ups in inflammatory subtype

NCT ID NCT06940154

Disease control Sponsor: Connect Biopharm LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 17, 2026 · Updated 5 times

Summary

This Phase 2 trial tests whether rademikibart, an injected drug, can help adults with COPD who are having a sudden flare-up and have a specific type of inflammation (type 2). The study will compare the drug to a placebo in 160 participants, looking at whether it reduces treatment failure—like hospital readmission or needing more steroids—within 28 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
rademikibart (also called CBP-201), a drug given as a shot
What this could lead to
If it works, this could point toward a new add-on treatment to reduce hospital visits and treatment failure during COPD flare-ups.
What could go wrong
This is an early Phase 2 trial with only 160 people, so results may not apply to everyone. The drug is experimental and may not work better than placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

159 people

The number who actually took part.

Started

Aug 2025

Finished

Aug 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 systemic corticosteroids (ie, oral or by injection) 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.

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COPD acute exacerbation

Contacts and locations

Locations

  • Acad. Chapidze Emergency Cardiology Center LLC

    Tbilisi, 0159, Georgia

  • Acad. G. Chapidze Emergency Cardiology Center

    Tbilisi, 0159, Georgia

  • Amicis Research Center

    Valencia, California, 91355, United States

  • Bendigo Health

    Bendigo, Victoria, 3550, Australia

  • CEMER - Centro Medico de Enfermedades Respiratorias

    Florida, Buenos Aires, B1602, Argentina

  • Campbelltown Hospital

    Campbelltown, New South Wales, 2560, Australia

  • Carilion Medical Center / Carilion Roanoke Memorial Hospital

    Roanoke, Virginia, 24014, United States

  • Caucasus Medical Center

    Tbilisi, 0159, Georgia

  • Centro Medico Ipam S.A

    Rosario, Santa Fe Province, S2000, Argentina

  • Centro de Diagnostivo y Rehabilitación S.A. - CEDIR

    Santa Fe, S3000, Argentina

  • Centro de Investigaciones Médicas Mar del Plata

    Mar del Plata, Buenos Aires, B7600FYK, Argentina

  • Clinical Hospital Center "Dragisa Misovic - Dedinje"

    Belgrade, 11040, Serbia

  • Clinical Research of Rock Hill

    Rock Hill, South Carolina, 29732, United States

  • Columbus Clinical Services, LLC

    Miami, Florida, 33125, United States

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

    McAllen, Texas, 78503, United States

  • Duke Asthma, Allergy, and Airway Center

    Durham, North Carolina, 27705, United States

  • Guy's and St Thomas NHS Foundation Trust

    London, SE1 7EH, United Kingdom

  • Health Center Uzice

    Užice, 31000, Serbia

  • Health Synergy Clinical Research, LLC

    West Palm Beach, Florida, 33407, United States

  • Hospital Italiano de Buenos Aires

    CABA, Buenos Aires, C1199, Argentina

  • Hospital Universitario Austral

    Pilar, Buenos Aires, 1629, Argentina

  • Inquest Clinical Research

    Baytown, Texas, 77521, United States

  • Institute for Pulmonary Diseases and Tuberculosis Nis

    Niš, 18108, Serbia

  • Institute for Pulmonary Diseases of Vojvodina

    Kamenitz, 21204, Serbia

  • Institute for Respiratory Health

    Nedlands, Western Australia, 6009, Australia

  • Instituto Ave Pulmo-Fundacion Enfisema

    Mar del Plata, Buenos Aires, 7600, Argentina

  • Investigaciones en Patologias Respiratorias SRL

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • JSC "National Center for Lung Health"

    Tbilisi, 0101, Georgia

  • LLC "Israel-Georgian Medical Research Clinic Healthycore"

    Tbilisi, 0112, Georgia

  • LLC Diacor

    Tbilisi, 0159, Georgia

  • Leland Stanford Junior University, Stanford Hospital

    Palo Alto, California, 94304, United States

  • Medicines Evaluation Unit Ltd.

    Wythenshawe, Greater Manchester, M23 9QZ, United Kingdom

  • National Jewish Health

    Denver, Colorado, 80206, United States

  • Ochsner Medical Complex - The Grove

    Baton Rouge, Louisiana, 70836, United States

  • Pharmax Research of South Florida, Inc.

    Miami, Florida, 33175, United States

  • Pivotal Research Solutions

    Stonecrest, Georgia, 30038, United States

  • Premier Pulmonary Critical Care and Sleep Medicine

    Denison, Texas, 75020, United States

  • Primeway Clinical Research Group

    Fayetteville, Georgia, 30214, United States

  • Queen Elizabeth hospital Birmingham

    Birmingham, B15 2GW, United Kingdom

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

    Salford, M6 8HD, United Kingdom

  • St. Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010, Australia

  • Stony Brook University Hospital

    Stony Brook, New York, 11733, United States

  • Sunshine Coast University Hospital

    Birtinya, Queensland, 4575, Australia

  • The Canberra Hospital

    Garran, Australian Capital Territory, 2605, Australia

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • University Clinical Center Kragujevac

    Kragujevac, 34000, Serbia

  • University Hospitals Birmingham NHS Foundation Trust Birmingham Heartlands Hospital

    Birmingham, B9 5SS, United Kingdom

  • University of Alabama at Birmingham Lung Health Center

    Birmingham, Alabama, 35233, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • Vermont Lung Center

    Colchester, Vermont, 05446, United States

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.