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CBP-201

Phase 2

Moderate-to-severe Atopic Dermatitis | Small molecule | Dermatology |Connect Biopharma Holdings Limited|Last Updated: May 1, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment556

FDA Designations

No designations recorded

Clinical trial landscape

CBP-201 · 3 trials · 2 indications

Phase 2 3
NCT05017480A Study to Evaluate the Efficacy and Safety of CBP-201 in Moderate to Severe Atopic Dermatitis in ChinaModerate-to-severe Atopic Dermatitis
COMPLETED330 Analytics
NCT04773678Efficacy and Safety of CBP-201 in Patients With Moderate to Severe Persistent Asthma With Type 2 InflammationModerate to Severe Persistent Asthma
COMPLETED322 Analytics
NCT04444752A Study to Assess the Efficacy and Safety of CBP-201 in Adult Subjects With Moderate to Severe Atopic DermatitisModerate-to-severe Atopic Dermatitis
COMPLETED226 Analytics
PHASE2COMPLETED
A Study to Evaluate the Efficacy and Safety of CBP-201 in Moderate to Severe Atopic Dermatitis in China
Moderate-to-severe Atopic DermatitisUnlock trial analytics
PHASE2COMPLETED
Efficacy and Safety of CBP-201 in Patients With Moderate to Severe Persistent Asthma With Type 2 Inflammation
Moderate to Severe Persistent AsthmaUnlock trial analytics
PHASE2COMPLETED
A Study to Assess the Efficacy and Safety of CBP-201 in Adult Subjects With Moderate to Severe Atopic Dermatitis
Moderate-to-severe Atopic DermatitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Investigator Global Assessment (IGA) (0-1)
Baseline to Week16

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 in prebronchodilator (trough) forced expiratory volume in the first second of expiration (FEV1)
at Week 12

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.

Percent Reduction in EASI Score From Baseline to Week 16
Reduction from baseline to 16 weeks

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.

Secondary Endpoints

Eczema Area and Severity Index (EASI)-75
Baseline to Week16
Change in Peak Pruritus Numerical Rating Scale(PP-NRS) (Decreased by ≥ 4 Points)
Baseline to Week16
Change in Peak Pruritus Numerical Rating Scale(PP-NRS) (Decreased by ≥ 3 Points)
Baseline to Week16
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CBP-201 DoseEXPERIMENTALCBP-201 Dose subcutaneous (SC) injection
PlaceboPLACEBO_COMPARATORsubcutaneous (SC) injection
CBP-201 Dose 1EXPERIMENTALCBP-201 Dose 1 subcutaneous (SC) injection.
CBP-201 Dose 2EXPERIMENTALCBP-201 Dose 2 subcutaneous (SC) injection.
CBP-201 Dose 3EXPERIMENTALCBP-201 Dose 3 subcutaneous (SC) injection

Interventions

NameTypeDescription
CBP-201DRUGCBP-201 subcutaneous(SC) injection.
PlaceboDRUGsubcutaneous(SC) injection
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Eligibility Criteria

Age Range12 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites48

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...

Countries:ChinaUnited StatesHungaryPolandSouth KoreaAustraliaNew Zealand
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Frequently asked questions about CBP-201

What is CBP-201 used for?

CBP-201 is an investigational small molecule being developed for moderate-to-severe atopic dermatitis and moderate to severe persistent asthma with type 2 inflammation. It has been studied in Phase 2 clinical trials for these conditions.

Who makes CBP-201?

CBP-201 is being developed by Connect Biopharma Holdings Limited, a biopharmaceutical company traded on the NASDAQ under the ticker symbol CNTB.

What phase is CBP-201 in?

CBP-201 is in Phase 2 clinical development. It has completed two Phase 2 trials, one in atopic dermatitis and one in asthma, and is not yet approved by regulatory authorities.

What clinical trials is CBP-201 in?

CBP-201 has been studied in three completed Phase 2 trials: NCT04444752 in moderate-to-severe atopic dermatitis, NCT04773678 in moderate to severe persistent asthma, and NCT05017480 in moderate to severe atopic dermatitis in China.

Is CBP-201 the same as any other drug?

CBP-201 is the sole name provided for this investigational drug. No alternative names have been reported for this compound.

How does CBP-201 work?

CBP-201 is a small molecule, but its specific molecular target has not been disclosed. It is being studied for its efficacy and safety in inflammatory conditions such as atopic dermatitis and asthma.