Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06099535
Status:
COMPLETED
Last Update Posted:
2023-10-25
First Post:
2023-10-10
Brief Title:
A Study of LNK01001 Capsule in Moderately to Severely Active Rheumatoid Arthritis
Sponsor:
Lynk Pharmaceuticals Co Ltd
Organization:
Lynk Pharmaceuticals Co Ltd
Study Overview
Official Title:
A Phase 2 Randomized Double-Blind Placebo-Controlled Multicenter Study of LNK01001 Capsule in Moderately to Severely Active Rheumatoid Arthritis Patients With Inadequate Response or Intolerance to csDMARDs
Status:
COMPLETED
Status Verified Date:
2023-10
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 study includes two periods In Period 1 Participants who meet eligibility criteria will be randomized in a 111 ratio to receive a twice-daily oral LNK01001 Dose A or LNK01001 Dose B or a matching placebo for 12 weeks Participants who receive a placebo in Period 1 will be re-randomized at Week 13 in a 11 ratio to receive a twice-daily oral LNK01001 Dose A or LNK01001 Dose B for 12 weeks period 2 Participants who receive LNK01001 Dose A and Dose B in Period 1 will maintain the treatment dose in Period 2
Detailed Description:
This study includes a 35-day screening period a 12-week randomized double-blind parallel-group placebo-controlled treatment period Period 1 a 12-week double-blind period Period 2 and a 28 to 35-day follow-up period FU
Participants who meet eligibility criteria will be randomized in a ratio of 111 to 3 treatment groups in period 1 the placebo group will be rerandomized in a 11 ratio to LNK01001 Dose A or LNK01001 Dose B at week 13
1 Group 1 LNK01001 Dose A BID Day 1 to Week 12 LNK01001 Dose A BID Week 13 and thereafter
2 Group 2LNK01001 Dose B BID Day 1 to Week 12 LNK01001 Dose B BID Week 13 and thereafter
3 Group 3 Placebo Day 1 to Week12 LNK01001 Dose A BID Week 13 and thereafter
4 Group 4 Placebo Day 1 to Week12 LNK01001 Dose B BID Week 13 and thereafter
Participants who complete the Week 12 visit end of Period 1 will enter Period 2 and continue to receive LNK01001 Dose A or Dose B treatment Starting at Week 12 rescue therapy is allowed
Participants who meet eligibility criteria will be randomized in a ratio of 111 to 3 treatment groups in period 1 the placebo group will be rerandomized in a 11 ratio to LNK01001 Dose A or LNK01001 Dose B at week 13
1 Group 1 LNK01001 Dose A BID Day 1 to Week 12 LNK01001 Dose A BID Week 13 and thereafter
2 Group 2LNK01001 Dose B BID Day 1 to Week 12 LNK01001 Dose B BID Week 13 and thereafter
3 Group 3 Placebo Day 1 to Week12 LNK01001 Dose A BID Week 13 and thereafter
4 Group 4 Placebo Day 1 to Week12 LNK01001 Dose B BID Week 13 and thereafter
Participants who complete the Week 12 visit end of Period 1 will enter Period 2 and continue to receive LNK01001 Dose A or Dose B treatment Starting at Week 12 rescue therapy is allowed
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