Tests LT-002-158 tablets for moderate-to-severe atopic dermatitis in adults
Tests whether LT-002-158 tablets, compared with a placebo, help adults with atopic dermatitis.
Plain-language title generated from the registry record
Registry title: Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Key facts
- Where
- Hangzhou, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07895615, who can take part
Where in China
- Hangzhou First People's HospitalHangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.
- Trial code
- NCT07895615
- Record updated
- 26 October 2026
- Original description
The goal of this clinical trial is to learn if drug LT-002-158 works to treat moderate-to-severe atopic dermatitis in adults. It will also learn about the safety of drug LT-002-158. The main questions it aims to answer are:Read full original descriptionShow less
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis
The goal of this clinical trial is to learn if drug LT-002-158 works to treat moderate-to-severe atopic dermatitis in adults. It will also learn about the safety of drug LT-002-158. The main questions it aims to answer are:
Does drug LT-002-158 reduce the signs and symptoms of moderate-to-severe atopic dermatitis in adults? What medical problems do participants have when taking drug LT-002-158? Researchers will compare drug LT-002-158 to a placebo (a look-alike substance that contains no drug) to see if drug LT-002-158 works to treat atopic dermatitis.
Participants will:
Take drug LT-002-158 or a placebo every day for 16 weeks. Visit the clinic per the study plan for checkups and tests.
Inclusion: Aged 18-75 years (inclusive) at the time of signing the Informed Consent Form (ICF), regardless of sex; Body mass index (BMI) >17.5 kg/m2, and body weight of ≥ 45.0 kg; A history of atopic dermatitis for at least 6 months prior to the screening visit (meeting the Hanifin-Rajka diagnostic criteria), and:; EASI score ≥ 16 at the screening and baseline visits; vIGA score ≥ 3 at the screening and baseline visits; BSA ≥ 10% at the screening and baseline visits; A weekly average PP-NRS score of ≥ 4 at baseline (with at least 4 days of evaluation results during the week prior to baseline); Inadequate response, intolerance or inappropriateness for topical corticosteroid (TCS) or topical calcineurin inhibitor (TCI) therapy within 6 months prior to the baseline visit). Inadequate response is defined as failure to achieve and maintain remission or low disease activity (equivalent to vIGA 0 [ clear] to 2 [mild]) despite at least 28 days of treatment with a medium-to-high-potency TCS regimen (± TCI, as applicable), or for the maximum duration recommended in the product prescribing information (e.g., 14 days for super-potent TCS), whichever is shorter; Participants must apply a stable dose of topical emollients (moisturizer) daily for at least 7 consecutive days immediately prior to the baseline visit, and should be willing to continue using moisturizer throughout the study; Female participants of childbearing potential and male participants, as well as their partners, must have no plans to conceive during the study and for 6 months after the last dose, and must agree to use highly effective contraceptive methods; Able to understand and voluntarily sign the written informed consent form; willing and able to complete the scheduled visits, treatments, examinations, and other procedures (e.g., diary card recording and collection) in accordance with the protocol requirements.
Exclusion: Concurrent presence of other skin diseases that may interfere with study assessments, such as psoriasis, tinea corporis, lupus erythematosus, cutaneous T-cell lymphoma, and severe contact dermatitis; Presence of active, chronic, or recurrent infection requiring systemic anti-infective treatment within 4 weeks prior to the baseline visit; or presence of an infection that at baseline judged of the investigator to be inadequately controlled, such as infectious eczema, impetigo, cellulitis, or pneumonia; Known or suspected primary or secondary immunodeficiency disease; history of splenectomy or functional asplenia; Presence of other active autoimmune diseases (excluding allergic rhinitis and asthma) or a history of invasive opportunistic infections; Other exclusion criteria specified in the protocol.