Testing VC005 tablets for adults 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 study is testing if VC005 tablets can help adults with moderate to severe eczema feel better and improve their quality of life.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 480 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Jiangsu vcare pharmaceutical technology co., LTD (industry)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06723080 on ClinicalTrials.gov

What this trial studies

This clinical trial is a multicenter, randomized, double-blind, controlled phase III study evaluating the efficacy and safety of VC005 tablets in adult patients suffering from moderate to severe atopic dermatitis. Participants will be assigned to receive either a low dose, high dose, or placebo of VC005. The study aims to assess the improvement in symptoms and quality of life for patients over the course of the trial. Regular visits and laboratory tests will be conducted to monitor the participants' responses to the treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with a diagnosis of moderate to severe atopic dermatitis who have not responded adequately to previous topical treatments.

Not a fit: Patients who have not been diagnosed with atopic dermatitis or those who cannot tolerate oral medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of moderate to severe atopic dermatitis in adults.

How similar studies have performed: Other studies have shown promise in treating atopic dermatitis with similar oral therapies, indicating a potential for success in this approach.

Eligibility criteria

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;

Where this trial is running

Nanjing, Jiangsu

• Chinese Academy of Medical Sciences Hospital for Skin Diseases — Nanjing, Jiangsu, China (RECRUITING)

Study contacts

• Principal investigator: qianjin Lu — Chinese Academy of Medical Sciences Hospital of Skin Disease
• Study coordinator: xiaojuan Lai

Conditions: Moderate to Severe Atopic Dermatitis