NCT07071610

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

A Phase II, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of LNK01004 Ointment in Adults With Atopic Dermatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Lynk Pharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	LNK01004 ointment 0.3%	LNK01004 ointment 0.3% BID
DRUG	LNK01004 ointment 1.0%	LNK01004 ointment 1.0% BID
DRUG	Vehicle	vehicle BID

Timeline

• Start date: 2025-03-18
• Primary completion: 2025-07-24
• Completion: 2025-07-24
• First posted: 2025-07-17
• Last updated: 2026-01-14

Locations

1 site across 1 country: China