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

NCT06723080 | Recruiting Phase 3

• 1 other identifier: VC005-302
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Moderate to Severe Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects achieving at least a 75% reduction in Eczema Area and Severity Index (EASI 75) from Baseline at Week 16

  week 16

Study Arms (3)

VC005 low dose group

EXPERIMENTAL

Drug: VC005 low dose group

VC005 high dose group

EXPERIMENTAL

Drug: VC005 high dose group

VC005 placebo group

PLACEBO COMPARATOR

Drug: VC005 Placebo group

Interventions

VC005 low dose group DRUG

VC005 low dose group repeat administration

VC005 low dose group

VC005 high dose group DRUG

VC005 high dose group repeat administration

VC005 high dose group

VC005 Placebo group DRUG

VC005 Placebo group repeat administration

VC005 placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• (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;

Sponsors & Collaborators

• Jiangsu vcare pharmaceutical technology co., LTD: lead

Study Sites (1)

Chinese Academy of Medical Sciences Hospital for Skin Diseases

Nanjing, Jiangsu, 210042, China

RECRUITING

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• qianjin Lu

  Chinese Academy of Medical Sciences Hospital of Skin Disease

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xiaojuan Lai

CONTACT

15358160458; lai_xiaojuan@vcarepharmatech.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 9, 2024
• Study Start: December 30, 2024
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: February 11, 2025

Record last verified: 2024-12

Locations

CN (1)