drugset / Trial / NCT07071610

A Study to Evaluate the Efficacy and Safety of LNK01004 Ointment in Adults With Atopic Dermatitis

NCT07071610 ↗

Phase 2 Completed 75 enrolled Lynk Pharmaceuticals Co., Ltd
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will evaluate the efficacy and safety of two concentrations (0.3 percent \[%\] and 1%) of twice daily LNK01004 ointment for the topical treatment in adult subjects with atopic dermatitis. This is a multicenter, randomized, double-blind, vehicle-controlled, 3-arm, parallel-group, dose-finding study in adult subjects with atopic dermatitis. Two concentrations of LNK01004 ointment (0.3% and 1%) and a vehicle control ointment will be equally randomized and evaluated following application to all atopic dermatitis lesions (except on the scalp) twice daily (morning and evening) for 8 weeks. This study will consist of 3 periods: up to 4 weeks screening, 8 weeks double-blind treatment, and 2 weeks post-treatment follow-up. Approximately 75 subjects (25 subjects for each group) with moderate to severe AD will be enrolled overall.

Timeline

Start
2025-03-18
Primary completion
2025-07-24
Completion
2025-07-24

Drugs

EvaluationDrugModalityDoseRoute
Subject LNK01004 Unknown 0.3 % Topical
Subject LNK01004 Unknown 1 % Topical

Indications