A Study of LNK01001 Capsule in Patients With Moderate to Severe Atopic Dermatitis
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LNK01001 Dose A Participants will receive LNK01001 Dose A BID for 12 weeks. |
Drug: LNK01001 Dose A
Capsules taken orally
|
| Experimental: LNK01001 Dose B Participants will receive LNK01001 Dose B BID for 12 weeks. |
Drug: LNK01001 Dose B
Capsules taken orally
|
| Placebo Comparator: placebo Participants will receive Placebo BID for 12 weeks. |
Drug: placebo
Capsules taken orally
|
Outcome Measures
Primary Outcome Measures
- Percent Change from Baseline in Eczema Area and Severity Index (EASI) Score [week 12]
- Treatment Emergent Adverse Events (TEAE), serious adverse event (SAE), adverse events leading to discontinuation [week 12]
Secondary Outcome Measures
- Percentage of Participants Who Achieved a 75% Reduction in EASI Score (EASI 75) [Week 4,8,12]
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 [Week 4,8,12]
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 [Week 4,8]
- Percentage of Participants Achieving a Reduction of ≥ 3 Points From Baseline in Worst Pruritus Numerical Rating Scale (NRS) [Week 4,8,12]
- Change From Baseline in NRS Score [Week 4,8,12]
- Percentage of Participants Achieving a Reduction of ≥ 2 Points From Baseline in IGA [Week 4,8,12]
- Percentage of Participants Who Achieved a 90% Reduction in EASI Score (EASI 90) [Week 4,8,12]
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) [Week 4,8,12]
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 [Week 4,8,12]
- Change From Baseline in DLQI Score [Week 4,8,12]
- Change From Baseline in POEM Score [Week 4,8,12]
Eligibility Criteria
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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jianzhong Zhang | Beijing | China |
Sponsors and Collaborators
- Lynk Pharmaceuticals Co., Ltd
Investigators
- Principal Investigator: Jianzhong Zhang, Peking University People's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LK001202