Atopic Dermatitis (AD)Phase 2NCT07186387
Study of LW402 in Moderate-to-Severe Atopic Dermatitis
A Phase 2 study testing LW402 in people with Atopic Dermatitis (AD), run by Shanghai Longwood Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This is a multi-center, randomized, double blind, placebo-controlled phase 2 study to evaluate the efficacy, safety, PK and PD ofLW402 in patients 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?
- LW402
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 11 May 2023to 13 Feb 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Diagnosed with AD for at least 12 months before Screening, with below requirements: 1) EASI score ≥16 at Screening and Baseline; 2) IGA score ≥3 at Screening and Baseline; 3) ≥10% BSA of AD involvement at Screening and Baseline
Who cannot join
- Not enough washing-out period for previous therapy. Concurrent disease/status which may potentially affect the efficacy/safety judgement.
- pregnancy. Other.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of LW402 in Patients With Moderate-to-Severe Atopic Dermatitis
This is a multi-center, randomized, double blind, placebo-controlled phase 2 study to evaluate the efficacy, safety, PK and PD ofLW402 in patients with moderate-to-severe atopic dermatitis.
Read the detailed description
The study consists of an up-to-4-week screening period, a 12-week double-blind treatment period and a 4-week safety follow-up period.
- Conditions
- Atopic Dermatitis (AD)
- Being tested
- LW402, LW402 placebo
- Keywords
- Moderate-to-severe
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LW402Drug
LW402 tablets
LW402 placeboDrug
LW402 placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| LW402 Low Dose | Experimental | LW402 administered orally, BID (low dose) Receives: Drug: LW402 |
| LW402 Medium Dose | Experimental | LW402 administered orally, BID (medium dose) Receives: Drug: LW402 |
| LW402 High Dose | Experimental | LW402 administered orally, BID (high dose) Receives: Drug: LW402 |
| Placebo | Placebo comparator | LW402 placebo administered orally, BID Receives: Drug: LW402 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving EASI-50 at week 12
Proportion of participants achieving EASI-50 (≥50% reduction from baseline in Eczema Area and Severity Index score) at week 12.
The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) will each be assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe).
Measured: 12 weeks
Secondary outcomes (4)
Proportion of participants achieving EASI-75 at week 12
Proportion of participants achieving EASI-75 (≥75% reduction from baseline in Eczema Area and Severity Index score) at week 12.
Measured: 12 weeks
Proportion of participants with IGA score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 12
Proportion of participants with Investigator's Global Assessment (IGA) score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 16.
IGA is an assessment instrument used in clinical studies to rate the severity of AD globally, based on a 6-point scale ranging from 0 (clear) to 5 (very severe).
Measured: 12 weeks
Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Measured: 16 weeks
PD: pSTAT3 and pSTAT5 inhibition rates
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start11 May 2023
- Primary completion25 Sep 2024
- Study completion13 Feb 2025
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Longwood Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186387
- Sponsor's protocol ID
- LW402-II-02
- Status last verified
- May 2023
- First submitted
- 15 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of LW402 in Patients With Moderate-to-Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07186387
- Acronym / sponsor ID
- LW402-II-02
- Conditions
- Atopic Dermatitis (AD)
- Keywords
- Moderate-to-severe
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Shanghai Longwood Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 May 2023 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 13 Feb 2025 (actual)
- First posted
- 22 Sep 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 is a multi-center, randomized, double blind, placebo-controlled phase 2 study to evaluate the efficacy, safety, PK and PD ofLW402 in patients with moderate-to-severe atopic dermatitis.
Detailed description
The study consists of an up-to-4-week screening period, a 12-week double-blind treatment period and a 4-week safety follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LW402 Low Dose | Experimental | Drug: LW402LW402 administered orally, BID (low dose) |
| LW402 Medium Dose | Experimental | Drug: LW402LW402 administered orally, BID (medium dose) |
| LW402 High Dose | Experimental | Drug: LW402LW402 administered orally, BID (high dose) |
| Placebo | Placebo comparator | Drug: LW402 placeboLW402 placebo administered orally, BID |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed with AD for at least 12 months before Screening, with below requirements: 1) EASI score ≥16 at Screening and Baseline; 2) IGA score ≥3 at Screening and Baseline; 3) ≥10% BSA of AD involvement at Screening and Baseline
Key exclusion criteria (2 listed)
- Not enough washing-out period for previous therapy. Concurrent disease/status which may potentially affect the efficacy/safety judgement.
- pregnancy. Other.
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 |
|---|---|---|
| LW402LW402 tablets | Drug | LW402 High Dose, LW402 Low Dose, LW402 Medium Dose |
| LW402 placeboLW402 placebo tablets | Drug | Placebo |
Primary outcome
Proportion of participants achieving EASI-50 at week 12
Time frame: 12 weeks
Proportion of participants achieving EASI-50 (≥50% reduction from baseline in Eczema Area and Severity Index score) at week 12. The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) will each be assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe).
4 secondary outcomes
Proportion of participants achieving EASI-75 at week 12
Time frame: 12 weeks
Proportion of participants with IGA score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 12
Time frame: 12 weeks
Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Time frame: 16 weeks
PD: pSTAT3 and pSTAT5 inhibition rates
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 LW402 in people with Atopic Dermatitis (AD), run by Shanghai Longwood Biopharmaceuticals 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 2 Oct 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving EASI-50 at week 12 (time frame: 12 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 2 Oct 2025.