Phase III Clinical Study of VC005 Tablets in Adult Patients with Moderate to Severe Atopic Dermatitis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of VC005 Tablets in Adult Patients with Moderate to Severe Atopic Dermatitis

This clinical trial is a multicenter, randomized, double-blind, controlled phase III clinical study

Study Overview

• Status: Recruiting
• Conditions: Moderate to Severe Atopic Dermatitis
• Intervention / Treatment: Drug: VC005 low dose group; Drug: VC005 high dose group; Drug: VC005 Placebo group

• Study Type: Interventional
• Enrollment (Estimated): 480
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: xiaojuan lai; Phone Number: 15358160458; Email: lai_xiaojuan@vcarepharmatech.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210042
      • Recruiting
      • Chinese Academy of Medical Sciences Hospital for Skin Diseases
      • Contact: Qianjin Lu
      • Contact: Jin Nie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

(1）The patient understands and voluntarily signs the Informed Consent Form (ICF), and has the willingness and ability to complete the regular visits,treatment plans, laboratory tests and other experimental procedures required by the program. (2) Male or female patients aged ≥18 and ≤75 years at the time of signing the ICF. (3) Meet Hanifin-Rajka diagnostic criteria at screening and have atopic dermatitis （AD) symptoms for at least 1 year prior to baseline. (4) At screening and baseline, meets criteria for moderately severe AD based on the investigator's assessment of 3 of the following:Eczema area and severity index (EASI) score ≥12;Psoriasis Area Severity Index (IGA) score ≥3;AD involvement in ≥10% of the Body Surface Area (BSA). (5) Recent (within 1 year prior to screening) topical treatment for AD with inadequate or intolerant clinical response, as determined by the investigator

Exclusion Criteria:

(1) Inability to swallow the test drug or refractory nausea and vomiting, malabsorption, extracorporeal biliary shunt, or the presence of a gastrointestinal disorder (e.g., Crohn's disease, ulcerative colitis, or short bowel syndrome) or other malabsorption condition that interferes with the absorption of the drug; (2) Current or history of lymphoproliferative disorders or presence of signs or symptoms suggestive of possible lymphoproliferative disorders of lymphoid tissue, including lymphadenopathy or splenomegaly; malignancies of any kind, or a history of any malignancy within the 5 years prior to Screening (except for completely resected carcinoma in situ of the cervix or non-metastatic squamous cell or basal cell carcinoma of the skin or papillary carcinoma of the thyroid gland); (3) Patients with prior thromboembolism (including deep vein thrombosis, pulmonary embolism, arterial thrombosis, etc.) or other high-risk groups prone to thromboembolism; (4) Patients with a history of herpes virus infection within the last 1 month or those with recurrent episodes of herpes zoster (≥2), disseminated herpes zoster, disseminated herpes simplex, or those for whom herpes zoster or herpes simplex infections cannot be excluded at this time;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VC005 low dose group	Drug: VC005 low dose group; VC005 low dose group repeat administration
Experimental: VC005 high dose group	Drug: VC005 high dose group; VC005 high dose group repeat administration
Placebo Comparator: VC005 placebo group	Drug: VC005 Placebo group; VC005 Placebo group repeat administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects achieving at least a 75% reduction in Eczema Area and Severity Index (EASI 75) from Baseline at Week 16	week 16

Collaborators and Investigators

• Sponsor: Jiangsu vcare pharmaceutical technology co., LTD
• Investigators: Principal Investigator: qianjin Lu, Chinese Academy of Medical Sciences Hospital of Skin Disease

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2024
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2027

Study Registration Dates

• First Submitted: December 5, 2024
• First Submitted That Met QC Criteria: December 5, 2024
• First Posted (Actual): December 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 7, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis, Atopic; Dermatitis; Eczema
• Other Study ID Numbers: VC005-302

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No