Atopic Dermatitis (AD)Phase 1/2NCT06931990
A Study to Explore the Safety, Tolerability, Efficacy, and Pharmacokinetics of LT-002-158 Tablets in Chinese Adult Subjects With Atopic Dermatitis
A Phase 1/2 study testing LT-002-158 tablets in people with Atopic Dermatitis (AD), run by Leadingtac Pharmaceutical (Shaoxing) Co., Ltd. at 1 site in China.
Trial 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. 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 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 4 Jun 2025to 30 Mar 2028
- Phase
- Phase 1/2
- 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
- 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.
Who cannot join
- 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.
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
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
jianzhong Zhang, +86 18001315877, Rmzjz@126.com
About this study
Official 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
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.
- Conditions
- Atopic Dermatitis (AD)
- Being tested
- LT-002-158 tablets
- 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-002-158 tabletsDrug
The subjects will orally administered LT-002-158 tablets once a day.
| Study group | Role | What they receive |
|---|---|---|
| LT-002-158 tablets low-dose group | Experimental | Not described Receives: Drug: LT-002-158 tablets |
| LT-002-158 tablets high-dose group | Experimental | Not described Receives: Drug: LT-002-158 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment emergent Adverse Events
Measured: up to 42 days
Secondary outcomes (3)
Area under the curve plasma concentration from time zero to last measurable concentration [AUC(0-last)]
Measured: up to 42 days
Maximum observed plasma concentration at steady state (Cmax,ss)
Measured: up to 42 days
Minimum observed plasma concentration at stead state (Cmin,ss)
Measured: up to 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start4 Jun 2025
- Primary completion17 Feb 2028 (estimated)
- Study completion30 Mar 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT06931990
- Sponsor's protocol ID
- LT2158CHN004
- Status last verified
- Aug 2026
- First submitted
- 2 Apr 2025
- Last updated
- 27 Aug 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 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06931990
- Acronym / sponsor ID
- LT2158CHN004
- Conditions
- Atopic Dermatitis (AD)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- 17 Feb 2028 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 17 Apr 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LT-002-158 tablets low-dose group | Experimental | Drug: LT-002-158 tablets |
| LT-002-158 tablets high-dose group | Experimental | Drug: LT-002-158 tablets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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-002-158 tabletsThe subjects will orally administered LT-002-158 tablets once a day. | Drug | LT-002-158 tablets high-dose group, LT-002-158 tablets low-dose group |
Primary outcome
Incidence and severity of treatment emergent Adverse Events
Time frame: up to 42 days
3 secondary outcomes
Area under the curve plasma concentration from time zero to last measurable concentration [AUC(0-last)]
Time frame: up to 42 days
Maximum observed plasma concentration at steady state (Cmax,ss)
Time frame: up to 42 days
Minimum observed plasma concentration at stead state (Cmin,ss)
Time frame: up to 42 days
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 27 Aug 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 1/2 study testing LT-002-158 tablets 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 6 inclusion and 7 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 27 Aug 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 (021-50561622, jxu@leadingtac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment emergent Adverse Events (time frame: up to 42 days). 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 27 Aug 2026.