Clinical trial NCT06085521: A Study of LNK01001 Capsule in Patients With Moderate to Severe Atopic Dermatitis
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficiency and Safety of LNK01001 Capsule in Patients With Moderate to Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Lynk Pharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-10-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:LNK01001 dose A (Day 1 to Week 12) Group 2:LNK01001 dose B (Day 1 to Week 12) Group 3: Matching placebo (Day 1 to Week 12)

Eligibility 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.

Primary outcomes:
measure: Percent Change from Baseline in Eczema Area and Severity Index (EASI) Score
timeFrame: week 12
Secondary outcomes:
measure: Percentage of Participants Who Achieved a 75% Reduction in EASI Score (EASI 75)
timeFrame: Week 4,8,12
measure: Percentage of Participants Achieving an Investigator Global Assessment (IGA) response
timeFrame: Week 4,8,12
measure: Percent Change from Baseline in EASI Score
timeFrame: Week 4,8
measure: Percentage of Participants Achieving a Reduction of ≥ 3 Points From Baseline in Worst Pruritus Numerical Rating Scale (NRS)
timeFrame: Week 4,8,12
measure: Change From Baseline in Worst Pruritus Numerical Rating Scale(NRS) Score
timeFrame: Week 4,8,12
measure: Percentage of Participants Achieving a Reduction of ≥ 2 Points From Baseline in Investigator Global Assessment (IGA)
timeFrame: Week 4,8,12
measure: Percentage of Participants Who Achieved a 90% Reduction in EASI Score (EASI 90)
timeFrame: Week 4,8,12
measure: Percentage of Participants Who Achieved a 50% Reduction in EASI Score (EASI 50)
timeFrame: Week 4,8,12
measure: Percent Change from Baseline in Scoring Atopic Dermatitis (SCORAD) Score
timeFrame: Week 4,8,12
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Score
timeFrame: Week 4,8,12
measure: Change From Baseline in Patient Oriented Eczema Measure (POEM) Score
timeFrame: Week 4,8,12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Jianzhong Zhang
Study officials:
affiliation: Peking University People's Hospital
name: Jianzhong Zhang
role: PRINCIPAL_INVESTIGATOR
References: