Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CBP-201 · 3 trials · 2 indications
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 |
|---|---|---|
| CBP-201 Dose | EXPERIMENTAL | CBP-201 Dose subcutaneous (SC) injection |
| Placebo | PLACEBO_COMPARATOR | 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 |
|---|---|---|
| CBP-201 | DRUG | CBP-201 subcutaneous(SC) injection. |
| Placebo | DRUG | subcutaneous(SC) injection |
Inclusion Criteria: 1. 12≤ age ≤75 years at the screening visit, male or female; 2. Diagnosed with atopic dermatitis (according to the American Academy of Dermatology's Guidelines of care for the management of atopic dermatitis, 2014\[1\]) at the screening, visit and: a) The subject has been su...
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 is not yet approved for any indication. Connect Biopharma Holdings Limited is developing it for these inflammatory conditions.
CBP-201 targets IL-4R, the interleukin-4 receptor. IL-4R is a receptor involved in type 2 inflammatory signaling. By binding to this receptor, CBP-201 is designed to interfere with the inflammatory pathways that drive conditions such as asthma and atopic dermatitis.
CBP-201 is being developed by Connect Biopharma Holdings Limited, which trades under the ticker CNTB. The company is advancing the drug through clinical development for moderate to severe persistent asthma and moderate-to-severe atopic dermatitis.
CBP-201 is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. Two Phase 2 trials have been completed, and no trials are currently active. The completed studies enrolled a combined total of 556 participants across asthma and atopic dermatitis indications.
CBP-201 has been evaluated 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 atopic dermatitis patients. All were randomized, double-blind, and placebo-controlled.