Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis

Korábbi kezelés

• 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.

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• 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.

• 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.