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Also known as Rademikibart in prefilled syringe
Rademikibart · 3 trials · 3 indications
Treatment failure is defined as death due to any cause, (re)admission to a hospital for COPD, ED (re)visit or unscheduled medical visit for worsening of COPD symptoms, or the necessity to intensify pharmacologic treatment (including second course of systemic steroids for COPD exacerbation) within 28 days after randomization.
Treatment failure is defined as death due to any cause, (re)admission to a hospital for asthma, ED (re)visit or unscheduled medical visit for worsening of asthma symptoms, or the necessity to intensify pharmacologic treatment (including second course of systemic steroids for asthma exacerbation) within 28 days after randomization.
| Arm | Type | Description |
|---|---|---|
| Rademikibart | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Rademikibart | DRUG | Single 300 mg dose as a 2-minute IV push |
| Rademikibart in prefilled syringe | COMBINATION_PRODUCT | Participants receive 600 mg (4mL) of rademikibart administered subcutaneously. |
| Matching placebo in prefilled syringe | DRUG | Participants receive 4mL of placebo matched to rademikibart administered subcutaneously. |
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 exa...
Rademikibart in prefilled syringe is an investigational small molecule being developed for acute asthma and acute COPD exacerbation. It is being studied as an add-on treatment for these acute respiratory conditions. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Rademikibart targets IL-4Rα, the alpha subunit of the interleukin-4 receptor. By modulating this target, the drug is intended to address inflammatory pathways involved in acute asthma and COPD exacerbations. This mechanism is being evaluated in clinical trials for its potential to reduce exacerbation severity.
Rademikibart in prefilled syringe is developed by Connect Biopharma Holdings Limited, a biopharmaceutical company traded on NASDAQ under the ticker CNTB. The company is conducting Phase 2 clinical trials to evaluate the drug's safety and efficacy in acute asthma and COPD exacerbation.
Rademikibart is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. Two Phase 2 trials are currently active, one recruiting and one active but not recruiting, studying the drug in patients with acute asthma or COPD exacerbation.
Rademikibart is being studied in three Phase 2 trials. NCT07705737 evaluates intravenous Rademikibart for acute asthma and COPD exacerbation in the US. NCT06940154 (Seabreeze STAT COPD) and NCT06940141 (Seabreeze STAT Asthma) assess add-on treatment in acute COPD and asthma exacerbations across multiple countries.
Yes, Rademikibart in prefilled syringe is also known as Rademikibart. The prefilled syringe formulation is a specific delivery method of the same drug substance. Clinical trials may use different formulations, such as intravenous administration, to evaluate the drug's effects.