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RecruitingNCT07895615Updated Oct 26, 2026

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

A Phase 2 interventional study of LT-002-158 and Placebo in Atopic Dermatitis (AD), sponsored by Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by Leadingtac Pharmaceutical (Shaoxing) Co., Ltd. · Phase 2, Interventional, and Treatment

Updated Oct 26, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

Read the detailed description

This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial in adult patients with moderate-to-severe AD. The study is designed to preliminarily evaluate the efficacy and safety of LT-002-158 Tablets in this population.

02

Conditions studied

  • Atopic Dermatitis (AD)

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Keywords

  • IRAK4
03

In context

Dermatitis, Atopic

1,444 studies on the registry are indexed under Dermatitis, Atopic; 253 are open to participants now.

This study's planned enrollment of 160 is above the median of 83 across 1,143 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Leadingtac Pharmaceutical (Shaoxing) Co., Ltd. is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
160 participants (estimated)

Study arms

  • Experimental
    LT-002-158

    LT-002-158 (Dose 1, Dose 2, Dose 3) administered once daily (QD)

    Drug: LT-002-158

  • Placebo comparator
    Placebo

    Other: Placebo

Interventions

  • DrugLT-002-158

    Drug: LT-002-158, oral, tablets

  • OtherPlacebo

    Placebo tablets

06

What researchers measure

Primary outcomes

  1. Eczema Area and Severity Index (EASI) score

    Percentage change from baseline in Eczema Area and Severity Index (EASI) score at Week 16

    Time frame: From enrollment to the end of treatment at 16 weeks

Secondary outcomes

  1. EASI-75

    Proportion of participants achieving ≥ 75% improvement from baseline in EASI score (EASI-75) at Week 16

    Time frame: From enrollment to the end of treatment at 16 weeks

  2. vIGA

    Proportion of participants achieving a validated Investigator Global Assessment (vIGA) score of 0 or 1 (vIGA 0/1) with an improvement of ≥ 2 points from baseline at Week 16

    Time frame: From enrollment to the end of treatment at 16 weeks

07

Study locations

1 of 1 sites recruiting
  • Hangzhou First People's Hospital
    Hangzhou, Zhejiang 310006, China
    • Liming Wu, MD · Contact · 18957118053@163.com · 13750837205
    • Liming Wu, MD · Principal investigator
    Recruiting
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07895615
Lead sponsor
Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.
Responsible party
Sponsor
First posted
Oct 26, 2026
Start date
Oct 2026 (estimated)
Primary completion
Jan 2028 (estimated)
Completion
May 2028 (estimated)
Last update
Oct 26, 2026

Study contacts

Juan Xu, Ph.D
Contact
jxu@leadingtac.com
18360466466

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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