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VC005 in moderate to severe atopic dermatitis
NCT05997927Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2023
- Primary completion
- Jul 2024
- Countries
- 1
- Sponsor
- Jiangsu Vcare PharmaTech Co., Ltd.
- Modality
- Small Molecules
- Drugs
- VC-005
- Conditions
- atopic dermatitis (AD)
01
Overview
Phase 2, randomised, double-blind trial of VC-005 in atopic dermatitis (AD) (4 arms), sponsored by Jiangsu Vcare PharmaTech Co., Ltd. Primary endpoint: Percentage change from baseline in Eczema Area and Severity Index score at 12 weeks. Started Jul 2023; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
VC005 Low Dose
VC005 Tablets Low Dose
VC005 Medium Dose
VC005 Tablets Medium Dose
VC005 High Dose
VC005 Tablets High Dose
Placebo
VC005 Tablets Placebo
03
Who it enrols
Adult patients with moderate to severe atopic dermatitis (EASI >= 12, IGA >= 3, BSA >= 10%) who have had inadequate response to topical treatments. Patients must not have current severe infections, history of malignancy within 5 years, or thromboembolism risks.
04
Endpoints
Primary
Percentage change from baseline in Eczema Area and Severity Index score
Secondary
Proportion of patients achieving at least 75% improvement in EASI score
Proportion of patients achieving at least 90% improvement in EASI score
Investigator's Global Assessment score of 0 or 1
05
Results
Primary endpoints met
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