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Also known as rademikibart, Rademikibart in prefilled syringe
CBP-201 · 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...
CBP-201 is an investigational drug being studied for moderate to severe persistent asthma and moderate-to-severe atopic dermatitis. It is in Phase 2 clinical development and has not been approved for any indication. Both conditions being studied involve type 2 inflammation, and the asthma trial specifically enrolled patients with type 2 inflammation.
CBP-201 targets IL-4R, the interleukin-4 receptor. IL-4R is a receptor that mediates signaling of interleukin-4 and interleukin-13, cytokines involved in type 2 inflammatory responses. By targeting this receptor, CBP-201 is designed to interfere with the inflammatory pathway underlying conditions such as atopic dermatitis and asthma.
CBP-201 is being developed by Connect Biopharma Holdings Limited, which trades under the ticker CNTB. The company has sponsored Phase 2 clinical trials of the drug in atopic dermatitis and asthma across multiple countries, including the United States, China, Australia, New Zealand, Hungary, Poland, and South Korea.
CBP-201 is in Phase 2 clinical development. It is investigational and has not been approved by the FDA or any other regulatory authority. Two completed Phase 2 trials are registered, one in moderate to severe persistent asthma and one in moderate-to-severe atopic dermatitis, with a combined enrollment of 556 participants.
CBP-201 has been studied in completed Phase 2 trials including NCT05017480 in moderate to severe atopic dermatitis in China, NCT04773678 in moderate to severe persistent asthma with type 2 inflammation across the United States, China, Hungary, Poland, and South Korea, and NCT04444752 in adult moderate to severe atopic dermatitis across the United States, Australia, China, and New Zealand.