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Rademikibart treatment for acute COPD flare-ups

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

Phase 2 Interventional Connect Biopharm LLC · NCT06940154

This study is testing if adding a new drug called rademikibart to regular treatment can help adults with COPD feel better during sudden flare-ups.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment160 (estimated)
Ages40 Years to 80 Years
SexAll
SponsorConnect Biopharm LLC Industry-sponsored
Locations51 sites (Birmingham, Alabama and 50 other locations)
Trial IDNCT06940154 on ClinicalTrials.gov

What this trial studies

This Phase 2 clinical trial investigates the efficacy of rademikibart, an investigational drug, as an add-on treatment for adults experiencing an acute exacerbation of chronic obstructive pulmonary disease (COPD) with type 2 inflammation. The study is designed as a randomized, double-blind, placebo-controlled trial, comparing the effects of rademikibart combined with standard therapy against standard therapy alone. Participants must have a history of COPD and meet specific criteria related to exacerbation severity and eosinophil counts. The trial aims to assess the safety and effectiveness of rademikibart in improving patient outcomes during acute exacerbations.

Who should consider this trial

Good fit: Ideal candidates are adults with a physician-diagnosed COPD who have experienced recent exacerbations requiring systemic corticosteroids.

Not a fit: Patients who do not have type 2 inflammation or those regularly using immunosuppressive medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery and management of acute COPD exacerbations for patients with type 2 inflammation.

How similar studies have performed: Previous studies have shown promise in targeting type 2 inflammation in COPD, suggesting potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion 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.
* 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.

The above inclusion and exclusion criteria are not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where this trial is running

Birmingham, Alabama and 50 other locations

+1 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions COPD Acute ExacerbationCOPDchronic obstructive pulmonary diseaserademikibartConnect BiopharmaCBP-201COPD exacerbationtype 2 inflammation
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.