Atopic Dermatitis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
LNK01004 ointment 0.3% for topical application
LNK01004 ointment 1.0% for topical application
DRUGLNK01004 ointment 1.5%
LNK01004 ointment 1.5% for topical application
DRUGVehicle BID
Inactive vehicle matched to LNK01004 ointment for topical application.
Sponsors
Lynk Pharmaceuticals Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants were diagnosed with atopic dermatitis (AD) for at least 6 months. * Participants with an Investigator's Global Assessment (IGA) score of 2 to 3 at screening and baseline. * Participants with body surface area (BSA) of AD involvement, excluding the scalp, face, and intertriginous areas, of 3% to 20% at screening and baseline. * BMI of 18.0-30.0 kg/m2, with body weight ≥ 50 kg for man and ≥ 40 kg for woman. * Be willing to comply with the study lifestyle restraints, e.g., no washing of the administered area within 6 hours of study drug administration, no sweaty exercise.
Exclusion criteria
* Participants with a physical condition which, in the Investigator´s opinion, might interfere with the assessment of atopic dermatitis or expose the patient to an unacceptable risk by study participation. * Participants with current evidence of any acute skin infection with a history of recurrent or chronic severe skin infection. * Participants with known allergies to components or excipients of the test drug. * Participants who are pregnant, nursing, or planning a pregnancy during the study period. * Systemic immunosuppressive or immunomodulating drugs (eg, oral or injectable corticosteroids, mycophenolate mofetil, PDE4 inhibitor) used for atopic dermatitis within 4 weeks or 5 half-lives of baseline (whichever is longer). * Participants with the following hematologic abnormities at screening: * Leukocytes \< 3.0 × 10\^9/L. * Neutrophils \< lower limit of normal. * Hemoglobin \< 10 g/dL. * Lymphocytes \< 0.8 × 10\^9/L * Platelets \< 100 × 10\^9/L. * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5 × upper limit of normal. * TBiL ≥ 1.5 × ULN, or ULN \< TBiL \< 1.5 × ULN but judged by the investigator to be abnormal clinically significant;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-Emergent Adverse Events (TEAE) | Baseline up to week 4 | Number of participants with at least one TEAE. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under plasma concentration versus time curve, time zero to infinity | Day 1 and Day7 | The area under the plasma concentration-time curve is a method of measurement of the total exposure of a drug in plasma |
| Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score | Baseline and Weeks 1, 2, and 4 | 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. |
| Maximum concentration (Cmax) for LNK01004 in plasma | Day1 and Day 7 | Cmax is defined as the maximum observed plasma concentration for LNK01004 |
| Number of Participants Achieving ≥4-Point Improvement in WI-NRS Pruritus Score | Baseline and Weeks 1, 2, and 4 | 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. |
| Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline | Baseline and Weeks 1, 2, and 4 | 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. |
| Number of Participants Achieving a 75% Decrease From Baseline in EASI Score (EASI-75) | Baseline and Weeks 1, 2, and 4 | 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. |
Countries
China
Outcome results
None listed