Atopic Dermatitis (AD)Phase 2NCT07895615
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 study testing LT-002-158 in people with Atopic Dermatitis (AD), run by Leadingtac Pharmaceutical (Shaoxing) Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atopic Dermatitis (AD)
- What is being tested?
- LT-002-158
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310006
Liming Wu, MD, 13750837205, 18957118053@163.com
Liming Wu, MD
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis
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.
- Conditions
- Atopic Dermatitis (AD)
- Being tested
- LT-002-158, Placebo
- Keywords
- IRAK4
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LT-002-158Drug
Drug: LT-002-158, oral, tablets
PlaceboOther
Placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| LT-002-158 | Experimental | LT-002-158 (Dose 1, Dose 2, Dose 3) administered once daily (QD) Receives: Drug: LT-002-158 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eczema Area and Severity Index (EASI) score
Percentage change from baseline in Eczema Area and Severity Index (EASI) score at Week 16
Measured: From enrollment to the end of treatment at 16 weeks
Secondary outcomes (2)
EASI-75
Proportion of participants achieving ≥ 75% improvement from baseline in EASI score (EASI-75) at Week 16
Measured: From enrollment to the end of treatment at 16 weeks
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
Measured: From enrollment to the end of treatment at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895615
- Sponsor's protocol ID
- LT2158CHN-AD-201
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07895615
- Acronym / sponsor ID
- LT2158CHN-AD-201
- Conditions
- Atopic Dermatitis (AD)
- Keywords
- IRAK4
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LT-002-158 | Experimental | Drug: LT-002-158LT-002-158 (Dose 1, Dose 2, Dose 3) administered once daily (QD) |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- 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.
Key exclusion criteria (5 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LT-002-158Drug: LT-002-158, oral, tablets | Drug | LT-002-158 |
| PlaceboPlacebo tablets | Other | Placebo |
Primary outcome
Eczema Area and Severity Index (EASI) score
Time frame: From enrollment to the end of treatment at 16 weeks
Percentage change from baseline in Eczema Area and Severity Index (EASI) score at Week 16
2 secondary outcomes
EASI-75
Time frame: From enrollment to the end of treatment at 16 weeks
vIGA
Time frame: From enrollment to the end of treatment at 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LT-002-158 in people with Atopic Dermatitis (AD), run by Leadingtac Pharmaceutical (Shaoxing) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Xu, Ph.D (18360466466, jxu@leadingtac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eczema Area and Severity Index (EASI) score (time frame: From enrollment to the end of treatment at 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.