Testing VC005 tablets for adults with moderate to severe atopic dermatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: lai_xiaojuan@vcarepharmatech.com
• Phone: 15358160458

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• A Phase 3 test of Rezpegaldesleukin (NKTR-358) for moderate-to-severe atopic dermatitis in patients 12 years and older

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  Recruiting at 13 sites Phase 3 Nektar Therapeutics · Birmingham, Alabama and 12 other locations · NCT07711418

• Rezpegaldesleukin for moderate-to-severe atopic dermatitis in people 12 and older

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• Nemolizumab for infants with moderate-to-severe atopic dermatitis

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• SYX-5219 in healthy adults and adults with moderate-to-severe atopic dermatitis

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• Oral LW402 for moderate-to-severe atopic dermatitis

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  Recruiting Phase 3 Shanghai Longwood Biopharmaceuticals Co., Ltd. · Beijing · NCT07370909

• SHR-1905 treatment for moderate-to-severe atopic dermatitis

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.