Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05732454
Status:
TERMINATED
Last Update Posted:
2024-05-22
First Post:
2022-12-22
Brief Title:
A Study to Learn About the Study Medicine Etrasimod in Adults With Moderate to Severe Atopic Dermatitis AD Who Have Already Tried Treatments Taken by Mouth or by Injection
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A PHASE 23 TWO-PART STUDY TO EVALUATE THE EFFICACY AND LONG-TERM SAFETY WITH ORAL ETRASIMOD 2 MG ONCE DAILY IN ADULT PARTICIPANTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS WITH A HISTORY OF PRIOR SYSTEMIC TREATMENT FAILURE
Status:
TERMINATED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Per the results of the planned interim analysis the study met futility criteria for efficacy so the trial was terminated This decision was made for efficacy reasons only and is not due to any safety concerns
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to learn about the safety and effects of the study medicine called etrasimod for the possible treatment of atopic dermatitis AD also called eczema in adults who have already tried AD treatments taken by mouth or by injection that work all over the body These adults can have moderate to severe AD
This study is seeking participants who
have AD for at least 1 year
have moderate-to-severe AD
have tried treatments that work all over the body and saw no effects
are willing to apply a moisturizer at least once daily during the study
This is a 2-part study that is only selecting about 60 participants for Part 1 as of now In Part 1 half of the participants will receive etrasimod a pill to be taken by mouth once daily The other half will receive a placebo a pill that looks like etrasimod but has no medicine also taken by mouth once daily No one will know what treatment the participant is taking The Sponsor will compare participant experiences of those taking etrasimod to those taking placebo for 16 weeks This will help determine if the study medicine is safe and effective After the first 16 weeks some participants may continue the study knowing they are taking etrasimod for an additional 52 weeks
Those participating for just the first 16-weeks will need to visit the study clinic at least 6 times during the study about every 4 weeks and will have to come for 2 safety follow up visits at 2nd and 4th week after the last dose of study medicine People who want to and can continue for an additional 52 weeks will need to visit the study clinic for at least 6 more visits making 12 total visits over 68 weeks followed by 2 safety follow up visits at the 2nd and 4th week after the last dose of study medicine
In Part 2 of the study around 340 more participants will be participating Everyone will receive etrasimod pills once daily for 52 weeks Participants will need to go to the study clinic at least 9 times after which they will have to go for 2 more safety follow up visits at the 2nd and 4th weeks after the last dose of study medicine
At every study visit in Part 1 and Part 2 the focus will be on signs and symptoms of AD like lesions itch and pain as well as general health and overall side effects Blood samples and vital signs will be taken at every visit Due to the way the study medicine works the in-study clinic visit will last at least 4 hours on Day 1 Part 1 and Part 2 and Week 16 Part 1
This study is seeking participants who
have AD for at least 1 year
have moderate-to-severe AD
have tried treatments that work all over the body and saw no effects
are willing to apply a moisturizer at least once daily during the study
This is a 2-part study that is only selecting about 60 participants for Part 1 as of now In Part 1 half of the participants will receive etrasimod a pill to be taken by mouth once daily The other half will receive a placebo a pill that looks like etrasimod but has no medicine also taken by mouth once daily No one will know what treatment the participant is taking The Sponsor will compare participant experiences of those taking etrasimod to those taking placebo for 16 weeks This will help determine if the study medicine is safe and effective After the first 16 weeks some participants may continue the study knowing they are taking etrasimod for an additional 52 weeks
Those participating for just the first 16-weeks will need to visit the study clinic at least 6 times during the study about every 4 weeks and will have to come for 2 safety follow up visits at 2nd and 4th week after the last dose of study medicine People who want to and can continue for an additional 52 weeks will need to visit the study clinic for at least 6 more visits making 12 total visits over 68 weeks followed by 2 safety follow up visits at the 2nd and 4th week after the last dose of study medicine
In Part 2 of the study around 340 more participants will be participating Everyone will receive etrasimod pills once daily for 52 weeks Participants will need to go to the study clinic at least 9 times after which they will have to go for 2 more safety follow up visits at the 2nd and 4th weeks after the last dose of study medicine
At every study visit in Part 1 and Part 2 the focus will be on signs and symptoms of AD like lesions itch and pain as well as general health and overall side effects Blood samples and vital signs will be taken at every visit Due to the way the study medicine works the in-study clinic visit will last at least 4 hours on Day 1 Part 1 and Part 2 and Week 16 Part 1
Detailed Description:
None
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 |
|---|---|---|---|
| 2022-003361-37 | EUDRACT_NUMBER | None | None |
| APD334-314 | OTHER | Alias Study Number | None |