Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06352073
Status:
RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-04-01
Brief Title:
Dupilumab for Eosinophilic Esophagitis With Severe Strictures
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Dupilumab for Eosinophilic Esophagitis With Severe Strictures DESTRICT Study
Status:
RECRUITING
Status Verified Date:
2024-08
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:
DESTRICT
Brief Summary:
The purpose of this research study is to determine how well an FDA-approved drug dupilumab works to treat patients with severe strictures and active Eosinophilic Esophagitis EoE This is an open-label study meaning everyone in the study will receive dupilumab
Participants will have a screening visit where they will complete surveys and undergo an endoscopy EGD Blood and biopsies small tissue samples will also be collected If eligible and enrolled into the study participants will receive weekly subcutaneous under the skin injections of dupilumab for 52 weeks one year The first dose of dupilumab will be administered at the week 1 visit by a clinician and participants will receive training on how to self-administer the remaining doses
Participants will return for study visits every at weeks 4 8 12 18 24 30 36 44 and 52 During these visits vital signs temperature heart rate etc will be collected and participants will complete surveys During visits at week 12 24 and 52 blood will be collected and an endoscopy with biopsy will be performed
At 64 weeks 12 weeks after the last dose of dupilumab participants assigned male at birth AMAB will be contacted about their their partners pregnancy status and participants assigned female at birth AFAB may be asked to come for an in-person visit to complete a urine pregnancy test
Participants will have a screening visit where they will complete surveys and undergo an endoscopy EGD Blood and biopsies small tissue samples will also be collected If eligible and enrolled into the study participants will receive weekly subcutaneous under the skin injections of dupilumab for 52 weeks one year The first dose of dupilumab will be administered at the week 1 visit by a clinician and participants will receive training on how to self-administer the remaining doses
Participants will return for study visits every at weeks 4 8 12 18 24 30 36 44 and 52 During these visits vital signs temperature heart rate etc will be collected and participants will complete surveys During visits at week 12 24 and 52 blood will be collected and an endoscopy with biopsy will be performed
At 64 weeks 12 weeks after the last dose of dupilumab participants assigned male at birth AMAB will be contacted about their their partners pregnancy status and participants assigned female at birth AFAB may be asked to come for an in-person visit to complete a urine pregnancy test
Detailed Description:
This research study aims to learn how well an FDA-approved drug called dupilumab works in treating patients with Eosinophilic Esophagitis EoE and severe strictures esophageal narrowing
This is an open-label study which means everyone enrolled will receive dupilumab Dupilumab is a weekly injection administered using a needle under the skin subcutaneous injection Dupilumab is already approved by the FDA for treating EoE
Participants will be part of the study for approximately 64 weeks In-person study visits will occur at specific intervals Study Visits will happen at the beginning of the study screening and weeks 1 4 8 12 18 24 30 36 44 and 52
Upper Endoscopies are performed at screening and weeks 12 24 and 52 or if participation ends early
Pregnancy Status Check 12 weeks after the last dose of dupilumab participants will be contacted about their pregnancy status
Assigned Male at Birth AMAB participants may receive a phone call
Assigned Female at Birth AFAB participants may return for an in-person visit to complete a urine pregnancy test
Study Procedures What Participants Can Expect
1 Consent Participants will review the study with the study team and have an opportunity to ask questions If they decide to participate they will sign a consent form
2 Screening Procedures These ensure eligibility for the study and include
Answering questions about demographics and medical history
A physical exam checking vital signs like temperature blood pressure heart rate and weight
Reviewing medications
Completing surveys about EoE symptoms feelings and quality of life
Providing a blood sample
Completing a urine pregnancy test if applicable
Undergoing an upper endoscopy EGD using a flexible lighted tube to examine the stomach small intestine and esophagus Sedation may be used during the procedure During the EGD tissue samples biopsies will be taken If the participant has narrowing in their esophagus a stricture that needs to be stretched dilated may also be dilated during the procedure
3 Enrollment visit Week 1 Once eligibility is confirmed participants will return to clinic to receive their first dose of dupilumab At this visit participants will
Complete surveys about EoE symptoms feelings and quality of life
Check vital signs temperature blood pressure respiratory rate heart rate and weight
Provide a blood sample
Complete a urine pregnancy test if applicable
Discuss lifestyle considerations that should be followed birth control methods medications and diet
Review medications and any new symptoms or medical history
A health care provider will give the first dose of dupilumab and teach participants andor their caregivers how to administer the medication at home
Receive dupilumab to take home and instructions for giving the medication weekly
4 Throughout the 1-year dosing period of the study participants andor their caregivers will continue to inject dupilumab at home each week and complete a dosing diary Participants will come to clinic at weeks 4 8 12 18 24 30 36 44 and 52 Procedures at these visits include
Completing surveys about EoE symptoms feelings and quality of life
Vital signs temperature blood pressure respiratory rate heart rate and weight
Providing a blood sample
Completing a urine pregnancy test if applicable
Discussing lifestyle considerations that should be followed birth control methods medications and diet
Reviewing medications and any new symptoms or medical history
During week 12 24 and 52 or at the end of the study there will also be an EGD with biopsies and dilation if necessary
Returning all used and unused dupilumab to the clinic
Receive dupilumab to take home and instructions for giving the medication weekly
512 weeks after the last dose of dupilumab participants will be contacted about their pregnancy status
Assigned Male at Birth AMAB participants may receive a phone call
Assigned Female at Birth AFAB participants may return for an in-person visit to complete a urine pregnancy test
This is an open-label study which means everyone enrolled will receive dupilumab Dupilumab is a weekly injection administered using a needle under the skin subcutaneous injection Dupilumab is already approved by the FDA for treating EoE
Participants will be part of the study for approximately 64 weeks In-person study visits will occur at specific intervals Study Visits will happen at the beginning of the study screening and weeks 1 4 8 12 18 24 30 36 44 and 52
Upper Endoscopies are performed at screening and weeks 12 24 and 52 or if participation ends early
Pregnancy Status Check 12 weeks after the last dose of dupilumab participants will be contacted about their pregnancy status
Assigned Male at Birth AMAB participants may receive a phone call
Assigned Female at Birth AFAB participants may return for an in-person visit to complete a urine pregnancy test
Study Procedures What Participants Can Expect
1 Consent Participants will review the study with the study team and have an opportunity to ask questions If they decide to participate they will sign a consent form
2 Screening Procedures These ensure eligibility for the study and include
Answering questions about demographics and medical history
A physical exam checking vital signs like temperature blood pressure heart rate and weight
Reviewing medications
Completing surveys about EoE symptoms feelings and quality of life
Providing a blood sample
Completing a urine pregnancy test if applicable
Undergoing an upper endoscopy EGD using a flexible lighted tube to examine the stomach small intestine and esophagus Sedation may be used during the procedure During the EGD tissue samples biopsies will be taken If the participant has narrowing in their esophagus a stricture that needs to be stretched dilated may also be dilated during the procedure
3 Enrollment visit Week 1 Once eligibility is confirmed participants will return to clinic to receive their first dose of dupilumab At this visit participants will
Complete surveys about EoE symptoms feelings and quality of life
Check vital signs temperature blood pressure respiratory rate heart rate and weight
Provide a blood sample
Complete a urine pregnancy test if applicable
Discuss lifestyle considerations that should be followed birth control methods medications and diet
Review medications and any new symptoms or medical history
A health care provider will give the first dose of dupilumab and teach participants andor their caregivers how to administer the medication at home
Receive dupilumab to take home and instructions for giving the medication weekly
4 Throughout the 1-year dosing period of the study participants andor their caregivers will continue to inject dupilumab at home each week and complete a dosing diary Participants will come to clinic at weeks 4 8 12 18 24 30 36 44 and 52 Procedures at these visits include
Completing surveys about EoE symptoms feelings and quality of life
Vital signs temperature blood pressure respiratory rate heart rate and weight
Providing a blood sample
Completing a urine pregnancy test if applicable
Discussing lifestyle considerations that should be followed birth control methods medications and diet
Reviewing medications and any new symptoms or medical history
During week 12 24 and 52 or at the end of the study there will also be an EGD with biopsies and dilation if necessary
Returning all used and unused dupilumab to the clinic
Receive dupilumab to take home and instructions for giving the medication weekly
512 weeks after the last dose of dupilumab participants will be contacted about their pregnancy status
Assigned Male at Birth AMAB participants may receive a phone call
Assigned Female at Birth AFAB participants may return for an in-person visit to complete a urine pregnancy test
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R668-EE-2380 | OTHER | Regeneron | None |