Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521762
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-21
Brief Title:
Etrasimod for Immune Checkpoint Inhibitor Diarrhea and Colitis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Etrasimod for Immune Checkpoint Inhibitor Diarrhea and Colitis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized double-blind placebo-controlled two-arm phase 2 study of etrasimod plus corticosteroids versus placebo plus corticosteroids for the treatment of Immune Checkpoint Inhibitor Diarrhea and Colitis IMDC CTCAE v50 grade 2 due to immune checkpoint inhibitors ICI therapy alone or combined with another ICI or ICI plus chemotherapy that in the opinion of the treating physician requires treatment with corticosteroid-based immunosuppression and does not require immediate secondary immune suppression
The purpose of this study is to improve the treatment of IMDC in people taking ICIs and find out if etrasimod combined with corticosteroids is more effective than a placebo combined with corticosteroids at lowering the total number of corticosteroids needed to treat IMDC
IMDC is one of the most common Immune Related Adverse Events irAEs from treatment with ICI Current guidelines recommend steroid treatment for IMDC CTCAE grade 2 which requires that ICI therapy be stopped Corticosteroids may interfere with ICIs and cannot be given at the same time Strategies are needed to reduce the dose and duration of corticosteroids needed for IMDC treatment and minimize the duration that patients have to be off ICI therapy ICIs are a type of immunotherapy
The purpose of this study is to improve the treatment of IMDC in people taking ICIs and find out if etrasimod combined with corticosteroids is more effective than a placebo combined with corticosteroids at lowering the total number of corticosteroids needed to treat IMDC
IMDC is one of the most common Immune Related Adverse Events irAEs from treatment with ICI Current guidelines recommend steroid treatment for IMDC CTCAE grade 2 which requires that ICI therapy be stopped Corticosteroids may interfere with ICIs and cannot be given at the same time Strategies are needed to reduce the dose and duration of corticosteroids needed for IMDC treatment and minimize the duration that patients have to be off ICI therapy ICIs are a type of immunotherapy
Detailed Description:
Participants will be screened as soon as IMDC is suspected but will not be randomized and administered the first dose of etrasimod or placebo until results from Clostridium difficile C difficile and other intestinal infection assays are confirmed to be negative Due to the acute nature of some cases of IMDC eg grade 4 IMDC some participants may require initiation of corticosteroids before enrollment Participants will undergo endoscopy within the first 7 days of starting study drug which will be repeated 7 to 14 days after completing the last dose of study drug Peripheral blood and stool will be collected prior to starting study drug and before starting corticosteroids if possible 14 to 21 days after starting treatment with etrasimod or placebo 7 to 10 days after completing etrasimod or placebo and for patients who restart ICI treatment 14 to 21 days after 1 cycle of ICI retreatment In situations in which it is not feasible to collect and process peripheral blood prior to starting etrasimod or placebo the sample should be collected and processed as soon as possible and no longer than 72 hours after starting etrasimod or placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None