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Also known as Rademikibart in prefilled syringe, CBP-201
Rademikibart · 6 trials · 5 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.
The percentage of subjects whose IGA score is 0-1 and decreased by ≥2 points The Validated Investigator Global Assessment for AD (vIGA-AD™) Scale is a 5-point classification scale based on the overall appearance of the skin lesions at a specific time point (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe).
Absolute change from Baseline in prebronchodilator (trough) FEV1 at Week 12. To assess the efficacy of CBP-201 (Dose 1 and Dose 2) versus placebo in patients with moderate to severe persistent asthma with type 2 inflammation as measured by lung function improvements.
EASI=Eczema Area Severity Index is a validated physician score for signs of atopic dermatitis. EASI can range from 0 to 72. An EASI score of 0 indicates clear/no eczema, 0.1 to 1.0 almost clear, 1.1 to 7 mild disease, 7.1 to 21 moderate disease, 21.1 to 50 severe disease, and 51-72 indicates very severe disease. EASI Sub-scale ranges are as follows: Head/neck can range from 0-7.2, Trunk 0-14.4, Upper Extremities 0-21.6, Lower Extremities can range from 0-28.8. To calculate EASI, % involvement is first assessed by body region with an Area involvement Score of 0-6 for each region: 0=0%, 1=1-9%, 2=10-29%, 3=30-39%, 4=50-69%, 5=70-89%, 6=90-100% involvement. Then 4 attributes (Erythema, Edema/Papulation, Excoriation, and Lichenification) are scored for severity (0= none, 1=mild, 2=moderate, 3=severe). A multiplier is applied head/neck=0.1, trunk=0.2, upper extremities= 0.3, lower extremities=0.4. The total EASI score is the sum of 4 regional sub-scores.
| Arm | Type | Description |
|---|---|---|
| Rademikibart | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| CBP-201 Dose | EXPERIMENTAL | CBP-201 Dose subcutaneous (SC) injection |
| CBP-201 Dose 1 | EXPERIMENTAL | CBP-201 Dose 1 subcutaneous (SC) injection. |
| CBP-201 Dose 2 | EXPERIMENTAL | CBP-201 Dose 2 subcutaneous (SC) injection. |
| CBP-201 Dose 3 | EXPERIMENTAL | CBP-201 Dose 3 subcutaneous (SC) injection |
| 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. |
| CBP-201 | DRUG | CBP-201 subcutaneous(SC) injection. |
| Placebo | DRUG | subcutaneous(SC) injection |
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 is an investigational therapy being studied for acute asthma and acute COPD exacerbations. It is designed as an add-on treatment during flare-ups of these respiratory conditions rather than as a maintenance therapy. The program is in Phase 2 clinical development and is not approved for any indication.
Rademikibart targets IL-4Rα, the interleukin-4 receptor alpha subunit. By binding this receptor, the drug is intended to interfere with IL-4 and IL-13 signaling, which are pathways involved in type 2 inflammation. This mechanism is relevant to the inflammatory component of acute asthma and COPD exacerbations.
Rademikibart is being developed by Connect Biopharma Holdings Limited, which trades under the ticker CNTB. The company is advancing the asset in respiratory indications, specifically acute asthma and acute COPD exacerbation, through Phase 2 clinical trials.
Rademikibart is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory authority. The program includes completed and ongoing Phase 2 studies in acute asthma and acute COPD exacerbation.
Rademikibart has been evaluated in Phase 2 trials including NCT06940154 in acute COPD exacerbation and NCT06940141 in acute asthma exacerbation, both completed. A third Phase 2 study, NCT07705737, evaluating intravenous Rademikibart for acute asthma and COPD exacerbation, is currently recruiting in the United States.
Yes. Rademikibart in prefilled syringe refers to the same drug candidate, Rademikibart, developed by Connect Biopharma Holdings Limited. The prefilled syringe description refers to a delivery format of the investigational product rather than a separate asset. Both names point to the same Phase 2 program in acute asthma and COPD exacerbation.