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

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.

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.