Safety, Tolerability and Pharmacokinetics of LNK01004 Ointment in Adults With Atopic Dermatitis.
- Conditions
- Atopic Dermatitis
- Interventions
- Drug: LNK01004 ointment 0.3%Drug: LNK01004 ointment 1.0%Drug: LNK01004 ointment 1.5%Drug: Vehicle BID
- Registration Number
- NCT06553287
- Lead Sponsor
- Lynk Pharmaceuticals Co., Ltd
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- 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.
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LNK01004 ointment 0.3% LNK01004 ointment 0.3% Participants will receive LNK01004 ointment 0.3% twice daily LNK01004 ointment 1.0% LNK01004 ointment 1.0% Participants will receive LNK01004 ointment 1.0% twice daily LNK01004 ointment 1.5% LNK01004 ointment 1.5% Participants will receive LNK01004 ointment 1.5% twice daily Vehicle Vehicle BID Participants will receive vehicle BID
- Primary Outcome Measures
Name Time Method Treatment-Emergent Adverse Events (TEAE) Baseline up to week 4 Number of participants with at least one TEAE.
- Secondary Outcome Measures
Name Time Method Maximum concentration (Cmax) for LNK01004 in plasma Day1 and Day 7 Cmax is defined as the maximum observed plasma concentration for LNK01004
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.
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.
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.
Trial Locations
- Locations (1)
Hospital for skin diseases, Institute of Dermatology, Chinese Academy of Medical Sciences.
🇨🇳Nanjing, China