Atopic DermatitisPhase 2NCT07071610

A Study to Evaluate the Efficacy and Safety of LNK01004 Ointment in Adults With Atopic Dermatitis

A Phase 2 study testing LNK01004 ointment 0.3% and LNK01004 ointment 1.0% in people with Atopic Dermatitis, run by Lynk Pharmaceuticals Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Atopic Dermatitis
What is being tested?: LNK01004 ointment 0.3% and LNK01004 ointment 1.0%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 75 participants
Where: 1 siteChina
Study dates: 18 Mar 2025to 24 Jul 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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Aged 18 to 65 years at screening.
Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for at least 3 months at screening.
Stable course of AD (not spontaneously improving or rapidly deteriorating) as determined by the investigator in the 3 weeks before screening.
IGA score of 3 to 4 at screening and baseline.
BSA of AD involvement, excluding the Scalp, Palms, and Soles, of 5% to 35% at screening and baseline.
Willingness to avoid pregnancy or fathering children based on the criteria as outlined in the protocol.

Who cannot join

Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would pose a significant risk to the participant or interfere with the interpretation of study data.
Concurrent conditions and history of:
Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before Baseline.
Active acute bacterial, fungal, or viral skin infection within 1 week before Baseline.
Any other concomitant skin disorder, pigmentation, or extensive scarring that, in the opinion of the investigator, may interfere with the evaluation of AD lesion.
Any other concomitant non-skin disorder with the treatment that may interfere with the evaluation of AD.

Show all 22Show fewer

Use of any of the following treatments within the indicated period before Baseline:
6 weeks: Dupilumab
5 half-lives or 12 weeks, whichever is longer: biologic agents (except dupilumab).
4 weeks: Janus kinase (JAK) inhibitors.
5 half-lives or 4 weeks, whichever is longer: Systemic therapy for AD, including but not limited to corticosteroids, methotrexate, cyclosporine, azathioprine, phosphodiesterase type 4 (PDE4)-inhibitors, Ultraviolet (UV) light therapy, or traditional Chinese medicine.
2 weeks: Sedating antihistamines.
1 week: Topical AD treatments (except topical emollient treatments), including but not limited to TCS, TCIs, or topical PDE-4 inhibitors.
Hepatitis B surface antigen (HBs Ag) positive (+); HCV ribonucleic acid (RNA) detectable in any subject with anti-HCV antibody (HCV Ab); Human immunodeficiency virus (HIV) positive (+).
Participants with the following hematologic abnormalities at screening:
ALT or AST ≥ 2 × ULN
TBiL ≥ 2 × ULN
Creatinine ≥ 1.5 × ULN
History of alcoholism or drug addiction within 6 months before screening or current alcohol or drug use.
Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before Baseline with another investigational medication or current enrollment in another investigational drug protocol.
Participants who are pregnant, nursing, or planning a pregnancy during the study period.
Participants with known allergies to components or excipients of the test drug.

Trial locations and contacts

1 site in 1 country.

China1 site

Peking University People's Hospital
Beijing

Other trials in China

About this study

Official title: A Phase II, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of LNK01004 Ointment in Adults With Atopic Dermatitis

This study will evaluate the efficacy and safety of two concentrations (0.3 percent [%] and 1%) of twice daily LNK01004 ointment for the topical treatment in adult subjects with atopic dermatitis. This is a multicenter, randomized, double-blind, vehicle-controlled, 3-arm, parallel-group, dose-finding study in adult subjects with atopic dermatitis. Two concentrations of LNK01004 ointment (0.3% and 1%) and a vehicle control ointment will be equally randomized and evaluated following application to all atopic dermatitis lesions (except on the scalp) twice daily (morning and evening) for 8 weeks.

This study will consist of 3 periods: up to 4 weeks screening, 8 weeks double-blind treatment, and 2 weeks post-treatment follow-up.

Approximately 75 subjects (25 subjects for each group) with moderate to severe AD will be enrolled overall.

Conditions: Atopic Dermatitis
Being tested: LNK01004 ointment 0.3%, LNK01004 ointment 1.0%, Vehicle
Medical subject headings: Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LNK01004 ointment 0.3%Drug
LNK01004 ointment 0.3% BID
LNK01004 ointment 1.0%Drug
LNK01004 ointment 1.0% BID
VehicleDrug
vehicle BID

Study groups in NCT07071610
Study group	Role	What they receive
Vehicle	Placebo comparator	Participants applied vehicle ointment BID for 8 weeks in DB period. Receives: Drug: Vehicle
LNK01004 ointment 0.3%	Experimental	Participants applied LNK01004 ointment 0.3% BID for 8 weeks in DB period. Receives: Drug: LNK01004 ointment 0.3%
LNK01004 ointment 1.0%	Experimental	Participants applied LNK01004 ointment 1.0% BID for 8 weeks in DB period. Receives: Drug: LNK01004 ointment 1.0%

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 8
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 regions of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement). 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 total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Measured: Baseline to week 8

Secondary outcomes (8)

Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 8
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 regions of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement). 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 total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Measured: Baseline to week 8
Percentage of Participants Who Achieve a ≥ 75% Improvement From Baseline in EASI (EASI-75) at Week 8
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 regions of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement). 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 total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Measured: Baseline to week 8
Percentage of Participants Who Achieve a ≥ 90% Improvement From Baseline in EASI (EASI-90) at Week 8
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 regions of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement). 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 total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Measured: Baseline to week 8
Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Week 2
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 regions of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement). 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 total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Measured: Baseline to week 2
Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points at Week 8
IGA is an assessment scale used to determine severity of atopic dermatitis (AD) and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). An IGA responder was defined as a participant achieving an IGA score of 0 to 1 and an IGA score improvement at least 2 from baseline.
Measured: Baseline to week 8
Percentage of Participants Achieving ≥4-Point Improvement in WI-NRS Pruritus Score at Week 8
The number of participants achieving a ≥4-point improvement from Baseline in WI-NRS score is presented. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours. Higher scores indicate greater symptom severity.
Measured: Baseline to week 8
Number of Participants with Any Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. TEAEs were defined as any AEs with an onset date during or after the first study treatment dose.
Measured: Baseline to week 10
Plasma Concentration of LNK01004
Measured: week 4,week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Mar 202524 Jul 2025

First posted17 Jul 2025
Study start18 Mar 2025
Primary completion24 Jul 2025
Study completion24 Jul 2025

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07071610
Sponsor's protocol ID: LK004201
Status last verified: Jan 2026
First submitted: 8 Jul 2025
Last updated: 14 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: This is due to proprietary and regulatory considerations. The data will remain confidential to protect intellectual property and participant privacy.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Atopic Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of LNK01004 Ointment in Adults With Atopic Dermatitis
ClinicalTrials.gov ID: NCT07071610
Acronym / sponsor ID: LK004201
Conditions: Atopic Dermatitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 75 participants (actual)
Lead sponsor: Lynk Pharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
Study start: 18 Mar 2025 (actual)
Primary completion: 24 Jul 2025 (actual)
Study completion: 24 Jul 2025 (actual)
First posted: 17 Jul 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 will consist of 3 periods: up to 4 weeks screening, 8 weeks double-blind treatment, and 2 weeks post-treatment follow-up.

Approximately 75 subjects (25 subjects for each group) with moderate to severe AD will be enrolled overall.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Vehicle	Placebo comparator	Drug: VehicleParticipants applied vehicle ointment BID for 8 weeks in DB period.
LNK01004 ointment 0.3%	Experimental	Drug: LNK01004 ointment 0.3%Participants applied LNK01004 ointment 0.3% BID for 8 weeks in DB period.
LNK01004 ointment 1.0%	Experimental	Drug: LNK01004 ointment 1.0%Participants applied LNK01004 ointment 1.0% BID for 8 weeks in DB period.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Aged 18 to 65 years at screening.
Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for at least 3 months at screening.
Stable course of AD (not spontaneously improving or rapidly deteriorating) as determined by the investigator in the 3 weeks before screening.
IGA score of 3 to 4 at screening and baseline.
BSA of AD involvement, excluding the Scalp, Palms, and Soles, of 5% to 35% at screening and baseline.

Key exclusion criteria (22 listed)

Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would pose a significant risk to the participant or interfere with the interpretation of study data.
Concurrent conditions and history of:
Use of any of the following treatments within the indicated period before Baseline:
Hepatitis B surface antigen (HBs Ag) positive (+); HCV ribonucleic acid (RNA) detectable in any subject with anti-HCV antibody (HCV Ab); Human immunodeficiency virus (HIV) positive (+).
Participants with the following hematologic abnormalities at screening:

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
LNK01004 ointment 0.3%LNK01004 ointment 0.3% BID	Drug	LNK01004 ointment 0.3%
LNK01004 ointment 1.0%LNK01004 ointment 1.0% BID	Drug	LNK01004 ointment 1.0%
Vehiclevehicle BID	Drug	Vehicle

Primary outcome

Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 8
Time frame: Baseline to week 8
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 regions of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement). 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 total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.

8 secondary outcomes

Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 8
Time frame: Baseline to week 8
Percentage of Participants Who Achieve a ≥ 75% Improvement From Baseline in EASI (EASI-75) at Week 8
Time frame: Baseline to week 8
Percentage of Participants Who Achieve a ≥ 90% Improvement From Baseline in EASI (EASI-90) at Week 8
Time frame: Baseline to week 8
Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Week 2
Time frame: Baseline to week 2
Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points at Week 8
Time frame: Baseline to week 8
Percentage of Participants Achieving ≥4-Point Improvement in WI-NRS Pruritus Score at Week 8
Time frame: Baseline to week 8
Number of Participants with Any Treatment-emergent Adverse Event (TEAE)
Time frame: Baseline to week 10
Plasma Concentration of LNK01004
Time frame: week 4,week 8

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 14 Jan 2026.
Individual participant dataSharing planned: No. This is due to proprietary and regulatory considerations. The data will remain confidential to protect intellectual property and participant privacy.

Related trials for Atopic Dermatitis

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
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RecruitingPhase 1
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Not yet recruitingPhase 1
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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 LNK01004 ointment 0.3% and LNK01004 ointment 1.0% 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 6 inclusion and 22 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 14 Jan 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?

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?

Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 8 (time frame: Baseline to week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07071610.

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 14 Jan 2026.