Back to resultsA Study of LNK01001 Capsule in Patients With Moderate to Severe Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
LNK01001 Dose A
LNK01001 Dose B
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
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.
Sites / Locations
- Jianzhong Zhang
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
LNK01001 Dose A
LNK01001 Dose B
placebo
Arm Description
Participants will receive LNK01001 Dose A BID for 12 weeks.
Participants will receive LNK01001 Dose B BID for 12 weeks.
Participants will receive Placebo BID for 12 weeks.
Outcomes
Primary Outcome Measures
Percent Change from Baseline in Eczema Area and Severity Index (EASI) Score
Treatment Emergent Adverse Events (TEAE), serious adverse event (SAE), adverse events leading to discontinuation
Secondary Outcome Measures
Percentage of Participants Who Achieved a 75% Reduction in EASI Score (EASI 75)
An EASI 75 response is defined as participants with at least a 75% reduction (improvement) in EASI score relative to the Baseline value
Percentage of Participants Achieving an Investigator Global Assessment (IGA) response
IGA response defined as an IGA score of 0 (clear) or 1 (almost clear) with a reduction from baseline of ≥ 2 points
Percent Change from Baseline in EASI Score
Percentage of Participants Achieving a Reduction of ≥ 3 Points From Baseline in Worst Pruritus Numerical Rating Scale (NRS)
Change From Baseline in NRS Score
Percentage of Participants Achieving a Reduction of ≥ 2 Points From Baseline in IGA
Percentage of Participants Who Achieved a 90% Reduction in EASI Score (EASI 90)
An EASI 90 response is defined as participants with at least a 90% reduction (improvement) in EASI score relative to the Baseline value
Percentage of Participants Who Achieved a 50% Reduction in EASI Score (EASI 50)
An EASI 50 response is defined as participants with at least a 50% reduction (improvement) in EASI score relative to the Baseline value
Percent Change from Baseline in SCORAD Score
Change From Baseline in DLQI Score
Change From Baseline in POEM Score
Full Information
NCT ID
NCT06085521
First Posted
October 10, 2023
Last Updated
October 10, 2023
Sponsor
Lynk Pharmaceuticals Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT06085521
Brief Title
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
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 26, 2022 (Actual)
Primary Completion Date
June 14, 2023 (Actual)
Study Completion Date
June 14, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lynk Pharmaceuticals Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LNK01001 Dose A
Arm Type
Experimental
Arm Description
Participants will receive LNK01001 Dose A BID for 12 weeks.
Arm Title
LNK01001 Dose B
Arm Type
Experimental
Arm Description
Participants will receive LNK01001 Dose B BID for 12 weeks.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive Placebo BID for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
LNK01001 Dose A
Intervention Description
Capsules taken orally
Intervention Type
Drug
Intervention Name(s)
LNK01001 Dose B
Intervention Description
Capsules taken orally
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Capsules taken orally
Primary Outcome Measure Information:
Title
Percent Change from Baseline in Eczema Area and Severity Index (EASI) Score
Time Frame
week 12
Title
Treatment Emergent Adverse Events (TEAE), serious adverse event (SAE), adverse events leading to discontinuation
Time Frame
week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieved a 75% Reduction in EASI Score (EASI 75)
Description
An EASI 75 response is defined as participants with at least a 75% reduction (improvement) in EASI score relative to the Baseline value
Time Frame
Week 4,8,12
Title
Percentage of Participants Achieving an Investigator Global Assessment (IGA) response
Description
IGA response defined as an IGA score of 0 (clear) or 1 (almost clear) with a reduction from baseline of ≥ 2 points
Time Frame
Week 4,8,12
Title
Percent Change from Baseline in EASI Score
Time Frame
Week 4,8
Title
Percentage of Participants Achieving a Reduction of ≥ 3 Points From Baseline in Worst Pruritus Numerical Rating Scale (NRS)
Time Frame
Week 4,8,12
Title
Change From Baseline in NRS Score
Time Frame
Week 4,8,12
Title
Percentage of Participants Achieving a Reduction of ≥ 2 Points From Baseline in IGA
Time Frame
Week 4,8,12
Title
Percentage of Participants Who Achieved a 90% Reduction in EASI Score (EASI 90)
Description
An EASI 90 response is defined as participants with at least a 90% reduction (improvement) in EASI score relative to the Baseline value
Time Frame
Week 4,8,12
Title
Percentage of Participants Who Achieved a 50% Reduction in EASI Score (EASI 50)
Description
An EASI 50 response is defined as participants with at least a 50% reduction (improvement) in EASI score relative to the Baseline value
Time Frame
Week 4,8,12
Title
Percent Change from Baseline in SCORAD Score
Time Frame
Week 4,8,12
Title
Change From Baseline in DLQI Score
Time Frame
Week 4,8,12
Title
Change From Baseline in POEM Score
Time Frame
Week 4,8,12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianzhong Zhang
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jianzhong Zhang
City
Beijing
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study of LNK01001 Capsule in Patients With Moderate to Severe Atopic Dermatitis
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