A Study of LNK01001 Capsule in Patients With Moderate to Severe Atopic Dermatitis

• Status: Completed
• Trial end date: 2023-06-14
• Target enrollment: 0
• Participant gender: All

Summary

Participants who meet eligibility criteria will be randomized in a 1:1:1 ratio to receive a twice daily oral LNK01001 dose A or LNK01001 dose B or matching placebo for 12 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lynk Pharmaceuticals Co., Ltd

Criteria

Inclusion Criteria:

• participants between ≥ 18 and ≤75 years of age.

• subjects meet Hanifin and Rajka criteria.

• subjects meet moderate to severe AD criteria.

• inadequate response to topical treatment or systemic treatment for AD within 6 months before screening.

Exclusion Criteria:

• current use of topical treatment for AD within 2 weeks before baseline visit.

• prior exposure to Janus Kinase (JAK) inhibitor.

• prior exposure to phototherapy, tanning bed, or any other light emitting device treatment within 4 weeks before baseline visit.

• Prior exposure to any Biologic treatment including Dupilumab, Omalizumab within 3 months before baseline visit.

• Any significant clinical and laboratory abnormalities, as determined by the Investigator, may affect the safety of the subjects, including but not limited to:WBC<3×10e9/L, neutrophil<1.2×10e9/L, platelet<100×10e9/L, hemoglobin<85 g/L; Aspartate aminotransferase or alanine aminotransferase>1.5×ULN, or total bilirubin>1.5×ULN; Serum creatinine>1.2×ULN.