Status:
COMPLETED
A Study of LNK01001 Capsule in Patients With Moderate to Severe Atopic Dermatitis
Lead Sponsor:
Lynk Pharmaceuticals Co., Ltd
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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.
Detailed Description
The study was to include a 12-week double-blind treatment period. Participants who met eligibility criteria were to be randomized in a 1:1:1 ratio to one of the three treatment groups. Group 1:LNK010...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06085521
Start Date
January 26 2022
End Date
June 14 2023
Last Update
October 27 2023
Active Locations (1)
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1
Jianzhong Zhang
Beijing, China