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

Last updated: April 9, 2025
Sponsor: Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Atopic Dermatitis

Allergy

Rash

Treatment

LT-002-158 tablets

Clinical Study ID

NCT06931990
LT2158CHN004
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. When signing the informed consent form, the age range is 18 to 75 years old (including threshold), and there is no gender limit.

  2. Body mass index (BMI) is between 17.5 and 40.0 kg/m2 (inclusive), with a weight of ≥ 45.0 kg.

  3. Insufficient response or intolerance to topical corticosteroids (TCS) or topicalcalcineurin inhibitors (TCI) within the last 6 months of randomization; Insufficientresponse is defined as the failure to achieve and maintain remission or low diseaseactivity (equivalent to vIGA 0=complete clearance to 2=mild) despite the use of amoderate to high efficacy TCS regimen (± TCI if applicable) for at least 28 days orthe longest duration recommended in the drug prescription information (e.g. 14 daysfor super potent TCS), whichever is shorter.

  4. Subjects must use topical moisturizers (moisturizers) daily for at least 7consecutive days prior to the baseline visit. Participants should continue to usedaily moisturizers during the study period.

  5. Female and male participants with fertility and their partners had no fertilityplans during the study period and within 6 months after the last dose, and agreed totake effective contraceptive measures.

  6. Understand and voluntarily sign written informed consent; Willing and able tocomplete planned visits, treatments, examinations, and other procedures (such asdietary requirements, diary card recording, and collection) according to therequirements of the plan.

Exclusion

Exclusion Criteria:

  1. Merge other skin diseases that may interfere with the study evaluation, such aspsoriasis, tinea corporis, lupus erythematosus, etc.

  2. Systemic anti infective therapy is required for active or chronic recurrentinfections within the 4 weeks prior to the baseline visit.

  3. Known or suspected to have a history of immune deficiency disease, other immunerelated diseases, invasive opportunistic infections or associated activetuberculosis.

  4. History of severe or recurrent herpes virus infection, such as herpeticencephalitis, disseminated herpes, etc.

  5. History of important organ transplantation (such as heart, lung, kidney, liver) orhematopoietic stem cell/bone marrow transplantation.

  6. After inquiry, there is a history of lymphoproliferative diseases; Or currentlysuffering from malignant tumors or having a history of malignant tumors (excludingsquamous cell carcinoma in situ of the skin, basal cell carcinoma, and cervicalcancer in situ, which have achieved complete remission after radical treatment formore than 5 years without any signs of recurrence).

  7. A family history of sudden death or long QT syndrome, or subjects with a history ofcongenital or drug-induced long QT syndrome.

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: LT-002-158 tablets
Phase: 1/2
Study Start date:
April 15, 2025
Estimated Completion Date:
December 30, 2025