RECRUITING

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

Conditions

Asthma Acute Acute exacerbation Asthma Asthma exacerbation CBP-201 Rademikibart Connect Biopharma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a Phase 2, randomized, multicenter study in adult and adolescent participants with asthma and type 2 inflammation

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 Adult and Adolescent Participants With Asthma and Type 2 Inflammation

Quick Facts

Study Start:2025-05

Study Completion:2026-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06940141

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Physician-diagnosed asthma with duration of ≥12 months (based on the GINA 2024 Guidelines). * Currently receiving treatment with low, medium, to high dose ICS (equivalent ICS doses as per GINA 2024 Guidelines) in combination with at least 1 additional asthma controller medication for at least 60 days prior to the Screening. * Must have experienced at least 1 asthma exacerbation requiring the use of systemic corticosteroids (oral or parenteral) within the previous 12 months prior to Screening. * For participants who consent/assent 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. * 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 prior to receiving IP.	* Regular use of immunosuppressive medication 12 weeks or 5 half-lives prior to randomization, whichever is longer. * Unstable ischemic heart disease, cardiomyopathy, heart failure (New York Heart Association Class III or IV), uncontrolled hypertension. * Current or former smoker, has a smoking history including: If \<30 years old: Smoked for ≥5 pack-years; If ≥30 years old: Smoked for ≥10 pack-years * COPD and other clinically significant pulmonary disease other than asthma. * Known or suspected history of immunosuppression. * History of known immunodeficiency disorder (including 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 with curative therapy \>1 year prior to entry or other malignancies treated with apparent success with curative therapy \>5 years prior to entry. * 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 (eg, suplatast tosilate) 30 days or 5 half-lives prior to randomization, whichever is longer. * Receipt of any marketed biologic drug or any investigational biologic for asthma 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. * Participants that have been treated with bronchial thermoplasty in the last 12 months prior to Visit 1b. * Treatment with OCS and/or hospitalization for an exacerbation of asthma less than 4 weeks prior to randomization. * Receipt of any investigational nonbiologic drug within 30 days or 5 half-lives prior to randomization, whichever is longer.

Inclusion Criteria

Exclusion Criteria

* Physician-diagnosed asthma with duration of ≥12 months (based on the GINA 2024 Guidelines).
* Currently receiving treatment with low, medium, to high dose ICS (equivalent ICS doses as per GINA 2024 Guidelines) in combination with at least 1 additional asthma controller medication for at least 60 days prior to the Screening.
* Must have experienced at least 1 asthma exacerbation requiring the use of systemic corticosteroids (oral or parenteral) within the previous 12 months prior to Screening.
* For participants who consent/assent 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.
* 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 prior to receiving IP.

* Regular use of immunosuppressive medication 12 weeks or 5 half-lives prior to randomization, whichever is longer.
* Unstable ischemic heart disease, cardiomyopathy, heart failure (New York Heart Association Class III or IV), uncontrolled hypertension.
* Current or former smoker, has a smoking history including: If \<30 years old: Smoked for ≥5 pack-years; If ≥30 years old: Smoked for ≥10 pack-years
* COPD and other clinically significant pulmonary disease other than asthma.
* Known or suspected history of immunosuppression.
* History of known immunodeficiency disorder (including 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 with curative therapy \>1 year prior to entry or other malignancies treated with apparent success with curative therapy \>5 years prior to entry.
* 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 (eg, suplatast tosilate) 30 days or 5 half-lives prior to randomization, whichever is longer.
* Receipt of any marketed biologic drug or any investigational biologic for asthma 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.
* Participants that have been treated with bronchial thermoplasty in the last 12 months prior to Visit 1b.
* Treatment with OCS and/or hospitalization for an exacerbation of asthma less than 4 weeks prior to randomization.
* Receipt of any investigational nonbiologic drug within 30 days or 5 half-lives prior to randomization, whichever is longer.

Contacts and Locations

Study Contact

Radha Adivikolanu

CONTACT

213-522-7990

clinical206@connectpharm.com

Study Locations (Sites)

Synergy Healthcare

Bradenton, Florida, 34209

United States

Collaborators and Investigators

Sponsor: Connect Biopharm LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05

Study Completion Date2026-05

Study Record Updates

Study Start Date2025-05

Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

Acute exacerbation
Asthma
Asthma exacerbation
CBP-201
Rademikibart
Connect Biopharma

Additional Relevant MeSH Terms

Asthma Acute