Safety, Tolerability and Pharmacokinetics of LNK01004 Ointment in Adults With Atopic Dermatitis.
NCT Number: NCT06553287
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Atopic Dermatitis
Interventions: DRUG: LNK01004 ointment 0.3%|DRUG: LNK01004 ointment 1.0%|DRUG: LNK01004 ointment 1.5%|DRUG: Vehicle BID
Sponsor: Lynk Pharmaceuticals Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 28
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-07-12
Completion Date: 2024-06-18
Locations: Hospital for skin diseases, Institute of Dermatology, Chinese Academy of Medical Sciences., Nanjing, China

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.

Primary Outcome Measures: Treatment-Emergent Adverse Events (TEAE), Number of participants with at least one TEAE., Baseline up to week 4
Secondary Outcome Measures: 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, 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