Home › Trials › NCT06940141

Rademikibart treatment for acute asthma exacerbations

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

Phase 2 Interventional Connect Biopharm LLC · NCT06940141

This study is testing if adding a new treatment called rademikibart to standard asthma care can help adults and teens with severe asthma attacks feel better.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment160 (estimated)
Ages12 Years to 75 Years
SexAll
SponsorConnect Biopharm LLC Industry-sponsored
Locations52 sites (Palo Alto, California and 51 other locations)
Trial IDNCT06940141 on ClinicalTrials.gov

What this trial studies

This Phase 2, randomized, double-blind, placebo-controlled trial investigates the efficacy of rademikibart in combination with standard therapy for adults and adolescents experiencing acute asthma exacerbations with type 2 inflammation. Participants will receive either rademikibart or a placebo alongside their usual asthma medications during an urgent healthcare visit. The study aims to determine if the addition of rademikibart can improve outcomes compared to standard treatment alone.

Who should consider this trial

Good fit: Ideal candidates include adults and adolescents with a history of asthma and recent acute exacerbations requiring systemic corticosteroids.

Not a fit: Patients who do not have type 2 inflammation or those who have not experienced recent asthma exacerbations may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide improved management of acute asthma exacerbations for patients with type 2 inflammation.

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

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Palo Alto, California and 51 other locations

+2 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 Asthma AcuteAcute exacerbationAsthmaAsthma exacerbationCBP-201RademikibartConnect Biopharma
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.