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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18-75 with moderate-to-severe atopic dermatitis (eczema) that has lasted at least 6 months and has not been controlled well by skin creams.
- Age
- 18-75 years
- Sex
- All sexes can join.
- Disease stage
- Moderate-to-severe atopic dermatitis for at least 6 months. At the screening and baseline visits: EASI score 16 or higher, vIGA score 3 or higher, and skin area affected (BSA) 10% or more. Weekly average itch score (PP-NRS) of 4 or higher at baseline.
- Earlier treatment
- Within 6 months before baseline, topical corticosteroid or topical calcineurin inhibitor creams did not work well enough, were not tolerated, or were not appropriate. Must use a stable dose of moisturizer daily for at least 7 days before baseline and keep using it during the study.
Main reasons for not taking part
- Other skin diseases that could affect the study checks, such as psoriasis or lupus erythematosus
- Infection needing treatment with medicines for the whole body within 4 weeks before baseline, or an infection that is not under control
- Known or suspected immune system deficiency, or removed or poorly working spleen
- Other active autoimmune disease (not allergic rhinitis or asthma), or past serious opportunistic infections
- Plans to have a child during the study or for 6 months after the last dose
Read by machine on 12 November 2026.
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, ChinaContact: Liming Wu, MDTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.