💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. Aged 18-75 years (inclusive) at the time of signing the Informed Consent Form (ICF), regardless of sex.
2. Body mass index (BMI) \>17.5 kg/m2, and body weight of ≥ 45.0 kg.
3. 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).
4. 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.
5. 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.
6. 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.
7. 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 Criteria:
1. 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.
2. 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.
3. Known or suspected primary or secondary immunodeficiency disease; history of splenectomy or functional asplenia.
4. 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.
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