Actively Recruiting
Phase III Study to Evaluate the Efficacy and Safety of VC005 Tablets in Adults With Moderate to Severe Atopic Dermatitis
Led by Jiangsu vcare pharmaceutical technology co., LTD · Updated on 2025-02-11
480
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the effects of VC005 tablets in adults with moderate to severe atopic dermatitis. The study focuses on adults aged 18 to 75 years who have had atopic dermatitis symptoms for at least one year and meet specific disease severity criteria. The purpose is to assess the efficacy and safety of this drug in managing the condition. Participants will be randomly assigned to one of three groups: a VC005 low dose group, a VC005 high dose group, or a VC005 placebo group. Each group will receive repeated administration of their assigned treatment over the course of the study. The study is designed to compare the effects of different doses of VC005 to placebo under double-blind conditions to ensure unbiased results. During the study, participants will attend regular visits to receive treatment, and undergo laboratory tests and other procedures as required by the study protocol. Researchers will measure the proportion of participants achieving at least a 75% improvement in the Eczema Area and Severity Index (EASI 75) from baseline after 16 weeks. Safety and treatment response will be carefully monitored throughout the study period, which is expected to continue until August 2027.
CONDITIONS
Brief Title
Phase III Clinical Study of VC005 Tablets in Adult Patients With Moderate to Severe Atopic Dermatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient understands and voluntarily signs the informed consent form and is willing and able to complete study visits, treatment, lab tests, and procedures.
- Male or female aged 18 to 75 years at the time of consent.
- Meets Hanifin-Rajka diagnostic criteria and has had atopic dermatitis symptoms for at least 1 year.
- At screening and baseline, has moderate to severe atopic dermatitis with EASI score ≥12, IGA score ≥3, and involvement of ≥10% body surface area.
- Has had topical treatment for atopic dermatitis within the past year with inadequate or intolerant response as determined by the investigator.
You will not qualify if you...
- Unable to swallow study medication or has gastrointestinal disorders interfering with drug absorption.
- Current or history of lymphoproliferative disorders, lymphadenopathy, splenomegaly, malignancies within 5 years (except certain skin or thyroid cancers).
- History of thromboembolism or high risk for thromboembolism.
- History of herpes virus infection within the last month or recurrent/disseminated herpes infections or unclear herpes infection status at screening.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants receive VC005 tablets at low dose, high dose, or placebo to treat moderate to severe atopic dermatitis.
Regular visits during treatment period
Trial Site Locations
Total: 1 location
1
Chinese Academy of Medical Sciences Hospital for Skin Diseases
Nanjing, Jiangsu, China, 210042
Actively Recruiting
Research Team
X
xiaojuan Lai
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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