Ignite Creation Date:
2024-05-06 @ 3:33 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04677179
Status:
TERMINATED
Last Update Posted:
2023-09-05
First Post:
2020-12-08
Brief Title:
A Study of LY3471851 in Adult Participants With Moderately to Severely Active Ulcerative Colitis UC
Sponsor:
Nektar Therapeutics
Organization:
Nektar Therapeutics
Study Overview
Official Title:
An Adaptive Phase 2 Randomized Double Blind Placebo Controlled Study of LY3471851 NKTR 358 in Patients With Moderately to Severely Active Ulcerative Colitis
Status:
TERMINATED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated due to enrollment futility
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INSTRUCT-UC
Brief Summary:
The reason for this study is to determine if the study drug LY3471851 is safe and effective in adult participants with active ulcerative colitis UC The study treatment will last about 52 weeks
Detailed Description:
In stage 1 two doses high and low of LY3471851 will be compared to placebo In stage 2 up to two additional doses to be confirmed of LY3471851 will be compared to placebo
LY3471851 NKTR-358 is a potential first-in-class therapeutic that may address an underlying immune system imbalance in people with many autoimmune conditions It targets the interleukin IL-2 receptor complex in the body in order to stimulate proliferation of inhibitory immune cells known as regulatory T cells By activating these cells LY3471851 may act to bring the immune system back into balance
LY3471851 NKTR-358 is a potential first-in-class therapeutic that may address an underlying immune system imbalance in people with many autoimmune conditions It targets the interleukin IL-2 receptor complex in the body in order to stimulate proliferation of inhibitory immune cells known as regulatory T cells By activating these cells LY3471851 may act to bring the immune system back into balance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| J1P-MC-KFAH | OTHER | None | None |
| 2020-003017-35 | EUDRACT_NUMBER | Eli Lilly and Company | None |