LT-002-158 tablets for moderate-to-severe atopic dermatitis in adults

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 is a multicenter, randomized, double-blind, placebo-controlled Phase II trial evaluating the safety and preliminary effectiveness of LT-002-158 tablets in adults with moderate-to-severe atopic dermatitis. Participants will take either LT-002-158 or placebo daily for 16 weeks, with regular clinic visits and assessments. Eligibility requires adults 18–75 with a confirmed history of AD and active disease measures at screening.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hangzhou First People's Hospital
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Juan Xu, Ph.D
• Email: jxu@leadingtac.com
• Phone: 18360466466

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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.