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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

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

Rademikibart Add-on Treatment of an Acute Asthma Exacerbation (Seabreeze STAT Asthma) (NCT06940141) is a Phase 2 interventional studying Asthma Acute, sponsored by Connect Biopharm LLC. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Asthma Acute and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 160 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Asthma Acute subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Physician-diagnosed asthma with duration of ≥12 months. - 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. - For participants in a stable condition, must have a documented 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. Who Should NOT Join This Trial: - Regular use of immunosuppressive medication. - Unstable ischemic heart disease, cardiomyopathy, heart failure, 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 weakened immune system 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 with curative therapy or other malignancies treated with apparent success with curative therapy. - Female participant who is pregnant, lactating or breast-feeding, or has a positive urinary β hCG test prior to randomization. - Recent receipt of any marketed nonbiologic drug that modulates type 2 cytokines (eg, suplatast tosilate). - Recent receipt of any marketed biologic drug or any investigational biologic for asthma or other diseases. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Physician-diagnosed asthma with duration of ≥12 months. * 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. * For participants in a stable condition, must have a documented 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: * Regular use of immunosuppressive medication. * Unstable ischemic heart disease, cardiomyopathy, heart failure, 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 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 with curative therapy or other malignancies treated with apparent success with curative therapy. * Female participant who is pregnant, lactating or breast-feeding, or has a positive urinary β hCG test prior to randomization. * Recent receipt of any marketed nonbiologic drug that modulates type 2 cytokines (eg, suplatast tosilate). * 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 treatment with OCS and/or hospitalization for an exacerbation of asthma. * Recent receipt of any investigational nonbiologic drug. * A recent chest X-ray or computed tomography (CT) with findings that are inconsistent for an asthmatic population. The above inclusion and exclusion criteria are not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Treatments Being Tested

COMBINATION_PRODUCT

Rademikibart in prefilled syringe

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

DRUG

Matching placebo in prefilled syringe

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

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Amicis Research Center
Valencia, California, United States
Synergy Healthcare
Bradenton, Florida, United States
Pharmax Research of South Florida, Inc.
Miami, Florida, United States
Columbus Clinical Services, LLC
Miami, Florida, United States
Health Synergy Clinical Research, LLC
West Palm Beach, Florida, United States
Primeway Clinical Research Group
Fayetteville, Georgia, United States
Pivotal Research Solutions
Stonecrest, Georgia, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Allergy & Asthma Specialists, P.S.C.
Owensboro, Kentucky, United States
Chesapeake Clinical Research, Inc.
White Marsh, Maryland, United States
Washington University School of Medicine
St Louis, Missouri, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Clinical Research of Rock Hill
Rock Hill, South Carolina, United States
Inquest Clinical Research
Baytown, Texas, United States
Premier Pulmonary Critical Care and Sleep Medicine
Denison, Texas, United States
DCT- McAllen Primary Care Research, LLC dba Discovery Clinical Trials
McAllen, Texas, United States
STAT Research
Caba, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
Caba, Buenos Aires, Argentina
Investigaciones en Alergias y Enfermoedades Respiratorias (InAER)
Caba, Buenos Aires, Argentina

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06940141), the sponsor (Connect Biopharm LLC), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06940141 clinical trial studying?

This is a Phase 2, randomized, multicenter study in adult and adolescent participants with asthma and type 2 inflammation The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06940141?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06940141?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06940141. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06940141. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.