Clinical trial NCT06553287: Safety, Tolerability and Pharmacokinetics of LNK01004 Ointment in Adults With Atopic Dermatitis.
Official title: A Phase Ib, Randomized, Double-Blind, Vehicle-Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LNK01004 Ointment in Adults Patients With Mild to Moderate Atopic Dermatitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atopic Dermatitis
Lead sponsor: Lynk Pharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-08-14
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Treatment-Emergent Adverse Events (TEAE)
timeFrame: Baseline up to week 4
Secondary outcomes:
measure: Maximum concentration (Cmax) for LNK01004 in plasma
timeFrame: Day1 and Day 7
measure: Area under plasma concentration versus time curve, time zero to infinity
timeFrame: Day 1 and Day7
measure: Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score
timeFrame: Baseline and Weeks 1, 2, and 4
measure: Number of Participants Achieving a 75% Decrease From Baseline in EASI Score (EASI-75)
timeFrame: Baseline and Weeks 1, 2, and 4
measure: Number of Participants Achieving ≥4-Point Improvement in WI-NRS Pruritus Score
timeFrame: Baseline and Weeks 1, 2, and 4
measure: Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline
timeFrame: Baseline and Weeks 1, 2, and 4
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Hospital for skin diseases, Institute of Dermatology, Chinese Academy of Medical Sciences.
Study officials:
affiliation: Hospital for skin diseases, Institute of Dermatology, Chinese Academy of Medical Sciences.
name: Qianjin Lu
role: PRINCIPAL_INVESTIGATOR
References: