Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06277245
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-02-02
Brief Title:
A Phase 3 Study of LNK01001 Capsule in Subjects With Moderate to Severe Atopic Dermatitis
Sponsor:
Lynk Pharmaceuticals Co Ltd
Organization:
Lynk Pharmaceuticals Co Ltd
Study Overview
Official Title:
A Phase 3 Randomized Placebo-Controlled Double-Blind Study to Evaluate LNK01001 in Adults Subjects With Moderate to Severe Atopic Dermatitis
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 2211 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 investigators discretion and will no longer be considered as rescue therapy for analysis
Participants who meet eligibility criteria will be randomized in a 2211 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 investigators discretion and will no longer be considered as rescue therapy for analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None