Rademikibart IV for Acute Asthma and COPD Exacerbation

A Phase 2, Open-Label, Single-Arm Trial to Evaluate IV Rademikibart as an Add-on Treatment for Acute Exacerbation in Participants With Asthma and or COPD With Type 2 Inflammation

A Phase 2, open-label, single-arm trial to evaluate IV rademikibart as an add-on treatment for acute exacerbation in participants with asthma or COPD with type 2 inflammation

Study Overview

• Status: Not yet recruiting
• Conditions: Asthma Acute; COPD Exacerbation Acute
• Intervention / Treatment: Drug: Rademikibart

Detailed Description

A phase 2, open-label, single-arm trial to assess the efficacy of a single 300 mg dose of rademikibart administered as a 2-minute IV infusion (IV push) on lung function in participants with asthma or COPD with type 2 inflammation who require an urgent healthcare visit for the treatment of acute exacerbation.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Radha Adivikolanu; Phone Number: 213-522-7990; Email: clinical209@connectpharm.com

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33135
      • Columbus Clinical Services, LLC
      • Contact: Radha Adivikolanu; Phone Number: 213-522-7990; Email: clinical209@connectpharm.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria - Asthma cohort

• Body weight of ≥40 kg and BMI ≤45 kg/m2 at SV1a.
• Physician-diagnosed asthma
• Currently receiving treatment with low, medium, to high dose ICS in combination with at least 1 additional asthma controller medication.
• Must have experienced at least 1 asthma exacerbation requiring the use of systemic corticosteroids.
• Participants in a stable condition, must have a historical peripheral blood eosinophil count of ≥250 cells/μL and/or FeNO ≥ 25 ppb.
• Current acute asthma exacerbation requiring an urgent healthcare visit for treatment.
• Peripheral blood eosinophil count of ≥300 cells/µL as part of the assessment of an index acute asthma exacerbation.
• Requires systemic corticosteroid as SoC in the urgent healthcare setting to treat the current acute asthma exacerbation.
• FEV1 ≥30% predicted.

Exclusion Criteria - Asthma cohort

• Regular use of immunosuppressive medication.
• Unstable ischemic heart disease, cardiomyopathy, heart failure, uncontrolled hypertension.
• Current or former smoker, with a smoking history of ≥5 pack-years if <30 years old or ≥10 pack-years if ≥30 years old
• COPD and other clinically significant pulmonary disease other than asthma.
• 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 or other malignancies treated with apparent success with curative therapy.
• Female participant who is pregnant, lactating or breast-feeding.
• Recent receipt of any marketed nonbiologic drug that modulates type 2 cytokines.
• Recent receipt of any marketed biologic drug or any investigational biologic for asthma or other diseases.
• Recent live, attenuated vaccinations or planned live, attenuated vaccinations during the trial.
• Participants that have been recently treated with bronchial thermoplasty.
• Recent receipt of any investigational nonbiologic drug.
• A recent chest X-ray or computed tomography with findings that are inconsistent for an asthmatic population.

Inclusion Criteria - COPD cohort

• Body weight of ≥45 kg and BMI ≤45 kg/m2
• Physician-diagnosed COPD
• Must have experienced at least 1 COPD exacerbation requiring the use of systemic corticosteroids.
• Participants in a stable condition must have a 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 - COPD cohort

• Regular use of immunosuppressive medication 12 weeks or 5 half-lives prior to approximately 12 weeks or 5 half-lives, 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, 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 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 scan reveals evidence of clinically significant abnormalities or pulmonary infection.
• Female participant who is pregnant, lactating or breast-feeding.
• Receipt of any marketed nonbiologic drug that modulates type 2 cytokines 30 days or 5 half-lives prior to SV1b, whichever is longer.
• Receipt of any marketed or any investigational biologic for COPD or other diseases within 16 weeks or 5 half-lives, whichever is longer.
• Live, attenuated vaccinations within 4 weeks prior to screening or planned live, attenuated vaccinations during the trial.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rademikibart	Drug: Rademikibart; Single 300 mg dose as a 2-minute IV push; Other Names: CBP-201

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in post-BD FEV1	1 week

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in post-BD FEV1 at scheduled timepoints	Days 1, 2, 3, 14, 28, and 42
Incidence of treatment-emergent adverse events	42 days

Collaborators and Investigators

• Sponsor: Connect Biopharm LLC

Study record dates

Study Major Dates

• Study Start (Estimated): July 30, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: July 10, 2026
• First Submitted That Met QC Criteria: July 10, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 10, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Asthma; COPD; Acute exacerbation; Asthma exacerbation; Asthma attack; COPD exacerbation; Connect Biopharma; CBP-201; Rademikibart; COPD acute; COPD flare
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Asthma
• Other Study ID Numbers: CBP-201-209

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No