Atopic DermatitisPhase 3NCT06277245
A Phase 3 Study of LNK01001 Capsule in Subjects With Moderate to Severe Atopic Dermatitis.
A Phase 3 study testing LNK01001 in people with Atopic Dermatitis, run by Lynk Pharmaceuticals Co., Ltd at 1 site in China.
Trial summary
This is a randomized, double-blind study comparing LNK01001 to placebo in participants with moderately to severely atopic dermatitis who were candidates for systemic therapy (ie, patients with a history of inadequate response to topical treatments, those who were using a systemic treatment, or those for whom topical… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- LNK01001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 356 participants
- Where
- 1 siteChina
- Study dates
- 6 Feb 2024to 12 Jan 2026
- Phase
- Phase 3
- 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
- Participants must be at least ≥18 and ≤75 years of age.
- The subject has a diagnosis of atopic dermatitis for at least 1 year.
- Meets the following disease activity criteria: BSA ≥10% of AD involvement. EASI ≥16. IGA ≥3. WI-NRS ≥4.
- Documented history of inadequate response to topical corticosteroids (TCS) or topical calcineurin inhibitor (TCI) or documented systemic treatment for AD within 6 months before Baseline Visit.
Who cannot join
- Vaccinated or exposed to a live or attenuated vaccine within the 6 weeks prior to the first dose of investigational product unable or unwilling to discontinue current atopic dermatitis treatments before the study.
- Requirement of prohibited medications during the study.
- Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions.
- History of malignancy or current diagnosis of malignancy before screening visit.
- In the opinion of the investigator or sponsor, any uncontrolled clinically significant laboratory abnormality that would affect the interpretation of study data or the subject's participation in the study uncontrolled diabetes, hypertension, kidney disease, liver disease, or severe heart disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate LNK01001 in Adults Subjects With Moderate to Severe Atopic Dermatitis.
This is a randomized, double-blind study comparing LNK01001 to placebo in participants with moderately to severely atopic dermatitis who were candidates for systemic therapy (ie, patients with a history of inadequate response to topical treatments, those who were using a systemic treatment, or those for whom topical treatments are otherwise medically inadvisable).
The objective of this study is to evaluate the efficacy and safety of LNK01001 in adult patients with moderate to severe AD who are candidates for systemic therapy.
Read the detailed description
This study includes a 35-day screening period; a 16-week randomized, placebo-controlled treatment period (Period 1); a 36-week long-term extension period (Period 2); and a 28 to 35-day follow-up period (FU).
Participants who meet eligibility criteria will be randomized in a 2:2:1:1 ratio to four treatment groups:
Group 1: LNK01001 12 mg BID (Day 1 to Week 16)， LNK01001 12 mg BID (Week 16 and thereafter) Group 2: LNK01001 24 mg BID (Day 1 to Week 16)， LNK01001 24 mg BID (Week 16 and thereafter) Group 3: Placebo (Day 1 to Week 16)， LNK01001 12 mg BID (Week 16 and thereafter) Group 4: Placebo (Day 1 to Week 16)， LNK01001 24 mg BID (Week 16 and thereafter)
Starting at Week 4, rescue therapy is allowed if medically necessary and the following parameters are met:
At Week 4 through Week 24: subjects with < 50% reduction in EASI response at any two consecutive scheduled visits, compared to the Baseline EASI score.
After Week 24: subjects with < 50% reduction in EASI at any scheduled or unscheduled visit, compared to the Baseline EASI score.
Starting at Week 16, the use of any concomitant topical medication for atopic dermatitis can be administered per the investigator's discretion and will no longer be considered as rescue therapy for analysis.
- Conditions
- Atopic Dermatitis
- Being tested
- LNK01001, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LNK01001Drug
Capsule; Oral
PlaceboDrug
Capsule; Oral
| Study group | Role | What they receive |
|---|---|---|
| LNK01001 12 mg | Experimental | o Period 1: Participants receive LNK01001 12 mg twice daily for 16 weeks. Period 2: Participants will continue on LNK01001 12 mg twice daily from Week 16 to Week 52. Receives: Drug: LNK01001 |
| LNK01001 24 mg | Experimental | o Period 1: Participants receive LNK01001 24 mg twice daily for 16 weeks. Period 2: Participants will continue on LNK01001 24 mg twice daily from Week 16 to Week 52. Receives: Drug: LNK01001 |
| Placebo / LNK01001 12 mg | Placebo comparator | o Period 1: Participants receive a placebo twice daily for 16 weeks. Period 2: Participants will switch to receive LNK01001 12 mg twice daily from Week 16 to Week 52. Receives: Drug: LNK01001; Drug: Placebo |
| Placebo / LNK01001 24mg | Placebo comparator | o Period 1: Participants receive a placebo twice daily for 16 weeks. Period 2: Participants will switch to receive LNK01001 24 mg twice daily from Week 16 to Week 52. Receives: Drug: LNK01001; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eczema Area and Severity Index (EASI-75) at Week 16
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease .
Measured: Baseline and Week 16
Investigator's Global Assessment (IGA) score of 0/1 at Week 16
Proportion of subjects achieving Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1) and a reduction from baseline of ≥2 points at Week 16.
Measured: Baseline and Week 16
Secondary outcomes (4)
Worst-Itch Numeric Rating Scale (WI-NRS-4)-4 at Week 16
Proportion of subjects achieving an improvement of Worst-Itch Numeric Rating Scale (WI-NRS) ≥4 from baseline at Week 16.
Measured: Baseline and Week 16
Worst-Itch Numeric Rating Scale (WI-NRS-4)-4 at all visits other than Week 16.
Proportion of subjects achieving an improvement of WI-NRS ≥4 from baseline at all scheduled visits other than Week 16.
Measured: Baseline to week 52 other than Week 16.
Change from Baseline in Eczema Area and Severity Index at all visits.
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease .
Measured: Baseline to week 52
Eczema Area and Severity Index (EASI 75) at all visits other than Week 16
Proportion of subjects achieving at least a 75% improvement in Eczema Area and Severity Index (EASI 75) from baseline at all visits other than Week 16.
Measured: Baseline to week 52 other than Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start6 Feb 2024
- Primary completion18 Apr 2025
- Study completion12 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lynk Pharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianzhong Zhang, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277245
- Sponsor's protocol ID
- LK001303
- Status last verified
- Jun 2025
- First submitted
- 2 Feb 2024
- Last updated
- 13 Apr 2026
- 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate LNK01001 in Adults Subjects With Moderate to Severe Atopic Dermatitis.
- ClinicalTrials.gov ID
- NCT06277245
- Acronym / sponsor ID
- LK001303
- Conditions
- Atopic Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- Lynk Pharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 18 Apr 2025 (actual)
- Study completion
- 12 Jan 2026 (actual)
- First posted
- 26 Feb 2024 (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 randomized, double-blind study comparing LNK01001 to placebo in participants with moderately to severely atopic dermatitis who were candidates for systemic therapy (ie, patients with a history of inadequate response to topical treatments, those who were using a systemic treatment, or those for whom topical treatments are otherwise medically inadvisable).
The objective of this study is to evaluate the efficacy and safety of LNK01001 in adult patients with moderate to severe AD who are candidates for systemic therapy.
Detailed description
This study includes a 35-day screening period; a 16-week randomized, placebo-controlled treatment period (Period 1); a 36-week long-term extension period (Period 2); and a 28 to 35-day follow-up period (FU).
Participants who meet eligibility criteria will be randomized in a 2:2:1:1 ratio to four treatment groups:
Group 1: LNK01001 12 mg BID (Day 1 to Week 16)， LNK01001 12 mg BID (Week 16 and thereafter) Group 2: LNK01001 24 mg BID (Day 1 to Week 16)， LNK01001 24 mg BID (Week 16 and thereafter) Group 3: Placebo (Day 1 to Week 16)， LNK01001 12 mg BID (Week 16 and thereafter) Group 4: Placebo (Day 1 to Week 16)， LNK01001 24 mg BID (Week 16 and thereafter)
Starting at Week 4, rescue therapy is allowed if medically necessary and the following parameters are met:
At Week 4 through Week 24: subjects with < 50% reduction in EASI response at any two consecutive scheduled visits, compared to the Baseline EASI score.
After Week 24: subjects with < 50% reduction in EASI at any scheduled or unscheduled visit, compared to the Baseline EASI score.
Starting at Week 16, the use of any concomitant topical medication for atopic dermatitis can be administered per the investigator's discretion and will no longer be considered as rescue therapy for analysis.
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 |
|---|---|---|
| LNK01001 12 mg | Experimental | Drug: LNK01001o Period 1: Participants receive LNK01001 12 mg twice daily for 16 weeks. Period 2: Participants will continue on LNK01001 12 mg twice daily from Week 16 to Week 52. |
| LNK01001 24 mg | Experimental | Drug: LNK01001o Period 1: Participants receive LNK01001 24 mg twice daily for 16 weeks. Period 2: Participants will continue on LNK01001 24 mg twice daily from Week 16 to Week 52. |
| Placebo / LNK01001 12 mg | Placebo comparator | Drug: LNK01001, Drug: Placeboo Period 1: Participants receive a placebo twice daily for 16 weeks. Period 2: Participants will switch to receive LNK01001 12 mg twice daily from Week 16 to Week 52. |
| Placebo / LNK01001 24mg | Placebo comparator | Drug: LNK01001, Drug: Placeboo Period 1: Participants receive a placebo twice daily for 16 weeks. Period 2: Participants will switch to receive LNK01001 24 mg twice daily from Week 16 to Week 52. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must be at least ≥18 and ≤75 years of age.
- The subject has a diagnosis of atopic dermatitis for at least 1 year.
- Meets the following disease activity criteria: BSA ≥10% of AD involvement. EASI ≥16. IGA ≥3. WI-NRS ≥4.
- Documented history of inadequate response to topical corticosteroids (TCS) or topical calcineurin inhibitor (TCI) or documented systemic treatment for AD within 6 months before Baseline Visit.
Key exclusion criteria (5 listed)
- Vaccinated or exposed to a live or attenuated vaccine within the 6 weeks prior to the first dose of investigational product unable or unwilling to discontinue current atopic dermatitis treatments before the study.
- Requirement of prohibited medications during the study.
- Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions.
- History of malignancy or current diagnosis of malignancy before screening visit.
- In the opinion of the investigator or sponsor, any uncontrolled clinically significant laboratory abnormality that would affect the interpretation of study data or the subject's participation in the study uncontrolled diabetes, hypertension, kidney disease, liver disease, or severe heart disease.
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 |
|---|---|---|
| LNK01001Capsule; Oral | Drug | LNK01001 12 mg, LNK01001 24 mg, Placebo / LNK01001 12 mg, Placebo / LNK01001 24mg |
| PlaceboCapsule; Oral | Drug | Placebo / LNK01001 12 mg, Placebo / LNK01001 24mg |
Primary outcome
Eczema Area and Severity Index (EASI-75) at Week 16
Time frame: Baseline and Week 16
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease .
Investigator's Global Assessment (IGA) score of 0/1 at Week 16
Time frame: Baseline and Week 16
Proportion of subjects achieving Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1) and a reduction from baseline of ≥2 points at Week 16.
4 secondary outcomes
Worst-Itch Numeric Rating Scale (WI-NRS-4)-4 at Week 16
Time frame: Baseline and Week 16
Worst-Itch Numeric Rating Scale (WI-NRS-4)-4 at all visits other than Week 16.
Time frame: Baseline to week 52 other than Week 16.
Change from Baseline in Eczema Area and Severity Index at all visits.
Time frame: Baseline to week 52
Eczema Area and Severity Index (EASI 75) at all visits other than Week 16
Time frame: Baseline to week 52 other than Week 16
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 13 Apr 2026.
- 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.
Jianzhong Zhang principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LNK01001 in people with Atopic Dermatitis, run by Lynk Pharmaceuticals 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 4 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: finished, as of the sponsor's last update on 13 Apr 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Eczema Area and Severity Index (EASI-75) at Week 16 (time frame: Baseline and Week 16). The study lists 2 primary outcomes in all. 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 13 Apr 2026.