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The purpose of the study is to evaluate the Safety, Tolerability, and Pharmacokinetics of LNK01004 ointment (0.3%, 1.0%, and 1.5%) vs vehicle twice daily (BID) in Adults Patients with Atopic Dermatitis.
This is a multicenter, randomized, double-blind, vehicle-controlled, dose-escalation study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LNK01004 ointment twice daily (BID) in participants with Mild to Moderate atopic dermatitis as compared with vehicle cream BID.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LNK01004 ointment 0.3% | Experimental | Participants will receive LNK01004 ointment 0.3% twice daily |
|
| LNK01004 ointment 1.0% | Experimental | Participants will receive LNK01004 ointment 1.0% twice daily |
|
| LNK01004 ointment 1.5% | Experimental | Participants will receive LNK01004 ointment 1.5% twice daily |
|
| Vehicle | Experimental | Participants will receive vehicle BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LNK01004 ointment 0.3% | Drug | LNK01004 ointment 0.3% for topical application |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-Emergent Adverse Events (TEAE) | Number of participants with at least one TEAE. | Baseline up to week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) for LNK01004 in plasma | Cmax is defined as the maximum observed plasma concentration for LNK01004 | Day1 and Day 7 |
| Area under plasma concentration versus time curve, time zero to infinity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qianjin Lu | Hospital for skin diseases, Institute of Dermatology, Chinese Academy of Medical Sciences. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for skin diseases, Institute of Dermatology, Chinese Academy of Medical Sciences. | Nanjing | China |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| LNK01004 ointment 1.0% |
| Drug |
LNK01004 ointment 1.0% for topical application |
|
| LNK01004 ointment 1.5% | Drug | LNK01004 ointment 1.5% for topical application |
|
| Vehicle BID | Drug | Inactive vehicle matched to LNK01004 ointment for topical application. |
|
The area under the plasma concentration-time curve is a method of measurement of the total exposure of a drug in plasma
| Day 1 and Day7 |
| Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score | The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI. | Baseline and Weeks 1, 2, and 4 |
| Number of Participants Achieving a 75% Decrease From Baseline in EASI Score (EASI-75) | The number of participants with a decrease of at least 75% from the baseline EASI total score is presented. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease), with positive results indicating an increase from baseline in EASI total score (i.e., increased symptoms) and negative results indicating a decrease from baseline score (i.e., decreased symptoms). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI. | Baseline and Weeks 1, 2, and 4 |
| Number of Participants Achieving ≥4-Point Improvement in WI-NRS Pruritus Score | The number of participants achieving a ≥4-point improvement from Baseline in WI-NRS score is presented. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours. Higher scores indicate greater symptom severity. | Baseline and Weeks 1, 2, and 4 |
| Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline | IGA is an assessment scale used to determine severity of atopic dermatitis (AD) and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). An IGA responder was defined as a participant achieving an IGA score of 0 to 1 and an IGA score improvement at least 2 from baseline. | Baseline and Weeks 1, 2, and 4 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |