Safety, Tolerability and Pharmacokinetics of LNK01004 Ointment in Adults With Atopic Dermatitis.

NCT06553287 | Completed Phase 1

• 1 other identifier: LK004102
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Treatment-Emergent Adverse Events (TEAE)

  Number of participants with at least one TEAE.

  Baseline up to week 4

Secondary Outcomes (6)

• Maximum concentration (Cmax) for LNK01004 in plasma

  Day1 and Day 7

• Area under plasma concentration versus time curve, time zero to infinity

  Day 1 and Day7

• Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score

  Baseline and Weeks 1, 2, and 4

• Number of Participants Achieving a 75% Decrease From Baseline in EASI Score (EASI-75)

  Baseline and Weeks 1, 2, and 4

• Number of Participants Achieving ≥4-Point Improvement in WI-NRS Pruritus Score

  Baseline and Weeks 1, 2, and 4

Study Arms (4)

LNK01004 ointment 0.3%

EXPERIMENTAL

Participants will receive LNK01004 ointment 0.3% twice daily

Drug: LNK01004 ointment 0.3%

LNK01004 ointment 1.0%

EXPERIMENTAL

Participants will receive LNK01004 ointment 1.0% twice daily

Drug: LNK01004 ointment 1.0%

LNK01004 ointment 1.5%

EXPERIMENTAL

Participants will receive LNK01004 ointment 1.5% twice daily

Drug: LNK01004 ointment 1.5%

Vehicle

EXPERIMENTAL

Participants will receive vehicle BID

Drug: Vehicle BID

Interventions

LNK01004 ointment 0.3% DRUG

LNK01004 ointment 0.3% for topical application

LNK01004 ointment 0.3%

LNK01004 ointment 1.0% DRUG

LNK01004 ointment 1.0% for topical application

LNK01004 ointment 1.0%

LNK01004 ointment 1.5% DRUG

LNK01004 ointment 1.5% for topical application

LNK01004 ointment 1.5%

Vehicle BID DRUG

Inactive vehicle matched to LNK01004 ointment for topical application.

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Lynk Pharmaceuticals Co., Ltd: lead

Study Sites (1)

Hospital for skin diseases, Institute of Dermatology, Chinese Academy of Medical Sciences.

Nanjing, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Qianjin Lu

  Hospital for skin diseases, Institute of Dermatology, Chinese Academy of Medical Sciences.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2024
• First Posted: August 14, 2024
• Study Start: July 12, 2023
• Primary Completion: June 18, 2024
• Study Completion: June 18, 2024
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

CN (1)