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NCT Number: NCT06931990

A Study to Explore the Safety, Tolerability, Efficacy, and Pharmacokinetics of LT-002-158 Tablets in Chinese Adult Subjects With Atopic Dermatitis

This study is an Ic/II phase clinical trial conducted in Chinese subjects with moderate to severe atopic dermatitis. The phase Ic study is a randomized, open label, parallel group design, mainly evaluating the safety and tolerability of LT-002-158 tablets in subjects with moderate to severe atopic dermatitis. The phase II study is a randomized, double-blind, placebo-controlled, parallel group design, with a single arm design for extended treatment, mainly exploring the efficacy of LT-002-158 tablets in the treatment of moderate to severe atopic dermatitis subjects.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • When signing the informed consent form, the age range is 18 to 75 years old (including threshold), and there is no gender limit.
  • Body mass index (BMI) is between 17.5 and 40.0 kg/m2 (inclusive), with a weight of ≥ 45.0 kg.
  • Insufficient response or intolerance to topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within the last 6 months of randomization; Insufficient response is defined as the failure to achieve and maintain remission or low disease activity (equivalent to vIGA 0=complete clearance to 2=mild) despite the use of a moderate to high efficacy TCS regimen (± TCI if applicable) for at least 28 days or the longest duration recommended in the drug prescription information (e.g. 14 days for super potent TCS), whichever is shorter.
  • Subjects must use topical moisturizers (moisturizers) daily for at least 7 consecutive days prior to the baseline visit. Participants should continue to use daily moisturizers during the study period.
  • Female and male participants with fertility and their partners had no fertility plans during the study period and within 6 months after the last dose, and agreed to take effective contraceptive measures.
  • Understand and voluntarily sign written informed consent; Willing and able to complete planned visits, treatments, examinations, and other procedures (such as dietary requirements, diary card recording, and collection) according to the requirements of the plan.

Exclusion criteria

  • Merge other skin diseases that may interfere with the study evaluation, such as psoriasis, tinea corporis, lupus erythematosus, etc.
  • Systemic anti infective therapy is required for active or chronic recurrent infections within the 4 weeks prior to the baseline visit.
  • Known or suspected to have a history of immune deficiency disease, other immune related diseases, invasive opportunistic infections or associated active tuberculosis.
  • History of severe or recurrent herpes virus infection, such as herpetic encephalitis, disseminated herpes, etc.
  • History of important organ transplantation (such as heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation.
  • After inquiry, there is a history of lymphoproliferative diseases; Or currently suffering from malignant tumors or having a history of malignant tumors (excluding squamous cell carcinoma in situ of the skin, basal cell carcinoma, and cervical cancer in situ, which have achieved complete remission after radical treatment for more than 5 years without any signs of recurrence).
  • A family history of sudden death or long QT syndrome, or subjects with a history of congenital or drug-induced long QT syndrome.

Treatment and study plan

LT-002-158 tablets

Drug

The subjects will orally administered LT-002-158 tablets once a day.

Primary outcomes

  1. Incidence and severity of treatment emergent Adverse Events

    Time frame: up to 42 days

Secondary outcomes

  1. Area under the curve plasma concentration from time zero to last measurable concentration [AUC(0-last)]

    Time frame: up to 42 days

  2. Maximum observed plasma concentration at steady state (Cmax,ss)

    Time frame: up to 42 days

  3. Minimum observed plasma concentration at stead state (Cmin,ss)

    Time frame: up to 42 days

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.

Industry

Registry information

Official study title

A Phase Ic/II Clinical Study to Explore the Safety, Tolerability, Efficacy, and Pharmacokinetics of Multiple Oral Doses of LT-002-158 Tablets in Chinese Adult Subjects With Atopic Dermatitis

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 17, 2025
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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