NCT06277245

A Phase 3 Study of LNK01001 Capsule in Subjects With Moderate to Severe Atopic Dermatitis.

A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate LNK01001 in Adults Subjects With Moderate to Severe Atopic Dermatitis.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 356 (actual)
• Sponsor: Lynk Pharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind study comparing LNK01001 to placebo in participants with moderately to severely atopic dermatitis who were candidates for systemic therapy (ie, patients with a history of inadequate response to topical treatments, those who were using a systemic treatment, or those for whom topical treatments are otherwise medically inadvisable). The objective of this study is to evaluate the efficacy and safety of LNK01001 in adult patients with moderate to severe AD who are candidates for systemic therapy.

Detailed description

This study includes a 35-day screening period; a 16-week randomized, placebo-controlled treatment period (Period 1); a 36-week long-term extension period (Period 2); and a 28 to 35-day follow-up period (FU). Participants who meet eligibility criteria will be randomized in a 2:2:1:1 ratio to four treatment groups: Group 1: LNK01001 12 mg BID (Day 1 to Week 16)， LNK01001 12 mg BID (Week 16 and thereafter) Group 2: LNK01001 24 mg BID (Day 1 to Week 16)， LNK01001 24 mg BID (Week 16 and thereafter) Group 3: Placebo (Day 1 to Week 16)， LNK01001 12 mg BID (Week 16 and thereafter) Group 4: Placebo (Day 1 to Week 16)， LNK01001 24 mg BID (Week 16 and thereafter) Starting at Week 4, rescue therapy is allowed if medically necessary and the following parameters are met: At Week 4 through Week 24: subjects with \< 50% reduction in EASI response at any two consecutive scheduled visits, compared to the Baseline EASI score. After Week 24: subjects with \< 50% reduction in EASI at any scheduled or unscheduled visit, compared to the Baseline EASI score. Starting at Week 16, the use of any concomitant topical medication for atopic dermatitis can be administered per the investigator's discretion and will no longer be considered as rescue therapy for analysis.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	LNK01001	Capsule; Oral
DRUG	Placebo	Capsule; Oral

Timeline

• Start date: 2024-02-06
• Primary completion: 2025-04-18
• Completion: 2026-01-12
• First posted: 2024-02-26
• Last updated: 2026-04-13

Locations

1 site across 1 country: China