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

NCT ID: NCT07071610

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-18
• Study Completion Date: 2025-07-24

Brief Summary

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Vehicle

Participants applied vehicle ointment BID for 8 weeks in DB period.

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: DRUG

vehicle BID

LNK01004 ointment 0.3%

Participants applied LNK01004 ointment 0.3% BID for 8 weeks in DB period.

Group Type: EXPERIMENTAL

LNK01004 ointment 0.3%

Intervention Type: DRUG

LNK01004 ointment 0.3% BID

LNK01004 ointment 1.0%

Participants applied LNK01004 ointment 1.0% BID for 8 weeks in DB period.

Group Type: EXPERIMENTAL

LNK01004 ointment 1.0%

Intervention Type: DRUG

LNK01004 ointment 1.0% BID

Interventions

LNK01004 ointment 0.3%

LNK01004 ointment 0.3% BID

Intervention Type: DRUG

LNK01004 ointment 1.0%

LNK01004 ointment 1.0% BID

Intervention Type: DRUG

Vehicle

vehicle BID

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lynk Pharmaceuticals Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University People's Hospital

Beijing, , China

Countries

China

Other Identifiers

LK004201

Identifier Type: -

Identifier Source: org_study_id