LT-002-158 tablets in 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 interventional, phase I/II trial in Chinese adults with moderate to severe atopic dermatitis evaluates LT-002-158 tablets. The phase I portion is randomized and open-label to assess safety and tolerability across parallel groups. The phase II portion is randomized, double-blind, and placebo-controlled, with an extended-treatment arm to explore efficacy. Eligible participants must have inadequate response or intolerance to topical therapies and use moisturizers daily. The study is conducted at a single center and led by Leadingtac Pharmaceutical, in collaboration with Peking University People’s Hospital.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. When signing the informed consent form, the age range is 18 to 75 years old (including threshold), and there is no gender limit.
2. Body mass index (BMI) is between 17.5 and 40.0 kg/m2 (inclusive), with a weight of ≥ 45.0 kg.
3. Insufficient response or intolerance to topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within the last 6 months of randomization; Insufficient response is defined as the failure to achieve and maintain remission or low disease activity (equivalent to vIGA 0=complete clearance to 2=mild) despite the use of a moderate to high efficacy TCS regimen (± TCI if applicable) for at least 28 days or the longest duration recommended in the drug prescription information (e.g. 14 days for super potent TCS), whichever is shorter.
4. Subjects must use topical moisturizers (moisturizers) daily for at least 7 consecutive days prior to the baseline visit. Participants should continue to use daily moisturizers during the study period.
5. Female and male participants with fertility and their partners had no fertility plans during the study period and within 6 months after the last dose, and agreed to take effective contraceptive measures.
6. Understand and voluntarily sign written informed consent; Willing and able to complete planned visits, treatments, examinations, and other procedures (such as dietary requirements, diary card recording, and collection) according to the requirements of the plan.

Exclusion Criteria:

1. Merge other skin diseases that may interfere with the study evaluation, such as psoriasis, tinea corporis, lupus erythematosus, etc.
2. Systemic anti infective therapy is required for active or chronic recurrent infections within the 4 weeks prior to the baseline visit.
3. Known or suspected to have a history of immune deficiency disease, other immune related diseases, invasive opportunistic infections or associated active tuberculosis.
4. History of severe or recurrent herpes virus infection, such as herpetic encephalitis, disseminated herpes, etc.
5. History of important organ transplantation (such as heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation.
6. After inquiry, there is a history of lymphoproliferative diseases; Or currently suffering from malignant tumors or having a history of malignant tumors (excluding squamous cell carcinoma in situ of the skin, basal cell carcinoma, and cervical cancer in situ, which have achieved complete remission after radical treatment for more than 5 years without any signs of recurrence).
7. A family history of sudden death or long QT syndrome, or subjects with a history of congenital or drug-induced long QT syndrome.

Where it's running

• Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Juan Xu
• Email: jxu@leadingtac.com
• Phone: 021-50561622

Similar studies

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

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• Stapokibart Injection for atopic dermatitis in adults

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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.