Eosinophilic EsophagitisPhase 4DESTRICTNCT06352073
Dupilumab for Eosinophilic Esophagitis With Severe Strictures
A Phase 4 study testing Dupilumab in people with Eosinophilic Esophagitis and EoE, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Eosinophilic Esophagitis, EoE
- What is being tested?
- Dupilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2024to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Requirements to be eligible for the study:
- Age 16 and older.
- Diagnosis of EoE (per 2018 AGREE consensus guidelines).
- Currently active EoE (defined as ≥15 eos/hpf [eosinophils per high power field]) based on samples taken from the screening endoscopy.
- Prior intolerance to or histologic non-response (defined as a peak esophageal eosinophil count of ≥15 eos/hpf) to proton pump inhibitors (PPI) and topical corticosteroids (tCS).
- For PPI, this must be after 8 weeks or more of treatment of at least 40mg daily of any of the approved medications.
- For tCS, this must be after 8 weeks or more of treatment of at least 2mg daily for budesonide or 1760 mcg daily for fluticasone).
- One of the following specific EoE features:
- A narrow esophagus (previous endoscopy with a severe, <10mm area of narrowing or where a standard adult endoscope would not fit), OR
- 4 or more prior esophageal dilations (stretching procedures) with at least 2 dilations occurring within one year.
- Willing to follow certain lifestyle considerations during the study including:
- No diet changes,
- No changes in PPI medication (such as omeprazole [Prilosec], esomeprazole [Nexium], lansoprazole [Prevacid], etc) dose,
- No topical/swallowed (such as flucticasone [Flovent], budesonide [Eohilia], etc) or systemic steroids (such as prednisone) for add-on EoE therapy,
- Use highly effective birth control methods (for people assigned female at birth who are able to get pregnant).
- Weigh at least 40kg (about 89 pounds or more).
Reasons a participant could be excluded:
- Other eosinophilic gastrointestinal (GI) disease including:
- Eosinophilic gastritis,
- Eosinophilic enteritis,
- Eosinophilic colitis,
- Hypereosinophilic syndrome.
- Recent steroid use (systemic or swallowed/topical corticosteroid within 4 weeks prior to the screening endoscopy).
- Recent use of dupilumab (Dupixent) (within about 5 months of screening) or prior allergic reaction to dupilumab or its components, or dupilumab intolerance.
- Recent use of other biologic medications (within either 5 months or 5 half-lives, whichever is longer). Examples of biologic medications include:
- mepolizumab (Nucala),
- reslizumab (Cinqair, Cinqaero),
- benralizumab (Fasenra),
- cendakimab,
- tezepelumab (Tezspire),
- barzolvolimab, etc.
- Prior esophageal resection (surgery to remove the esophagus).
- Participants taking blood thinners (such as coumadin, warfarin, heparin, etc.) who are unable to stop taking them for a brief period prior to EGD (as required by normal clinical practice).
- Recent vaccination with a live (attenuated) vaccine (within 4 weeks of screening). Live vaccines include:
- Chickenpox (varicella),
- FluMist and Intranasal influenza,
- Measles (rubeola),
- Mumps,
- Rubella,
- Oral polio,
- Oral typhoid,
- Smallpox (vaccinia),
- Yellow fever,
- Bacille Calmette-Guerin
- Rotavirus
- Combination vaccines of any of the above.
- Study doctor's determination that it would not be medically safe to complete an EGD.
- Inability to read or understand English.
- Currently pregnant or breastfeeding.
- Currently in screening or eligible for another study of dupilumab (Dupixent).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Dupilumab for Eosinophilic Esophagitis With Severe Strictures (DESTRICT Study)
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 in the clinic at the enrollment visit (day 0) and participants (or their caregivers) will receive training on how to self-administer the remaining doses.
Read more
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 female at birth (AFAB) may be asked to come to the clinic for a urine pregnancy test.
Read the 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 52-64 weeks. In-person study visits will occur at specific intervals. Study Visits will happen at the beginning of the study (screening), day 0 (enrollment), and weeks 4, 8, 12, 18, 24, 30, 36, 44, and 52 post-enrollment.
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 Assigned Female at Birth (AFAB) may return to the clinic for a urine pregnancy test.
Study Procedures: What Participants Can Expect
- 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.
- 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, height, 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.
- Enrollment visit (Day 0): 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 (and/or their caregivers) how to administer the medication at home.
- Receive dupilumab to take home and instructions for giving the medication weekly.
- Throughout the 1-year dosing period of the study, participants (and/or 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.
5.12 weeks after the last dose of dupilumab, participants Assigned Female at Birth (AFAB) participants may return for an in-person visit to complete a urine pregnancy test.
- Conditions
- Eosinophilic Esophagitis, EoE
- Being tested
- Dupilumab
- Keywords
- EoE, Stricture, dupilumab, Eosinophilic Esophagitis
- Medical subject headings
- Eosinophilic Esophagitis, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
Also called Dupilumab Pre-filled Syringe, Dupixent
300mg weekly subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Open Label dupilumab | Other | Open label dupilumab 300mg injection given subcutaneously weekly, for 52 weeks. Receives: Drug: Dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histologic Response to Dupilumab
Proportion (percentage) of patients with histologic response, defined as <15 eosinophils per high-power field (eos/hpf), after 24 weeks of dupilumab 300mg weekly.
Measured: 24 weeks
Secondary outcomes (4)
Change in Minimum Esophageal Caliber
Change in minimum esophageal caliber (measured in millimeters (mm)) as measured using EndoFLIP (Endoluminal Functional Lumen Imaging Probe) from baseline to week 24.
Measured: 24 weeks
Decrease in Number of Dilations
Decrease in the total number of esophageal dilations (esophageal stretching) required throughout the study (which includes four endoscopies - screening, week 12, week 24, and week 52) compared to the number of dilations performed over the four endoscopies prior to study entry.
Measured: 52 weeks
Change in Endoscopic Severity
Change in endoscopic severity, measured using the EoE Endoscope Reference Score (EREFS), from baseline to week 24. The score ranges from 0-9, with higher scores indicating greater severity.
Measured: 24 weeks
Change in Histologic Severity
Change in histologic severity, measured using the EoE Histologic Scoring System (HSS), from baseline to week 24. The HSS score ranges from 0-1, with higher scores indicating greater severity. This study will compare both grade (most severe area) and stage (extent of involvement) parameters of the HSS.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start16 May 2024
- Primary completion16 Apr 2026
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals, Sanofi
- Responsible party
- Sponsor
- Investigators
- Evan S Dellon, MD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352073
- Sponsor's protocol ID
- 23-2625
- Other IDs
- R668-EE-2380
- Acronym
- DESTRICT
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dupilumab for Eosinophilic Esophagitis With Severe Strictures (DESTRICT Study)
- ClinicalTrials.gov ID
- NCT06352073
- Acronym / sponsor ID
- DESTRICT / 23-2625
- Conditions
- Eosinophilic Esophagitis, EoE
- Keywords
- EoE, Stricture, dupilumab, Eosinophilic Esophagitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals, Sanofi
- Study start
- 16 May 2024 (actual)
- Primary completion
- 16 Apr 2026 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 in the clinic at the enrollment visit (day 0) and participants (or their caregivers) 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 female at birth (AFAB) may be asked to come to the clinic for 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 52-64 weeks. In-person study visits will occur at specific intervals. Study Visits will happen at the beginning of the study (screening), day 0 (enrollment), and weeks 4, 8, 12, 18, 24, 30, 36, 44, and 52 post-enrollment.
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 Assigned Female at Birth (AFAB) may return to the clinic for a urine pregnancy test.
Study Procedures: What Participants Can Expect
- 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.
- 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, height, 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.
- Enrollment visit (Day 0): 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 (and/or their caregivers) how to administer the medication at home.
- Receive dupilumab to take home and instructions for giving the medication weekly.
- Throughout the 1-year dosing period of the study, participants (and/or 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.
5.12 weeks after the last dose of dupilumab, participants Assigned Female at Birth (AFAB) participants may return for an in-person visit to complete a urine pregnancy test.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label dupilumab | Other | Drug: DupilumabOpen label dupilumab 300mg injection given subcutaneously weekly, for 52 weeks. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DupilumabAlso: Dupilumab Pre-filled Syringe, Dupixent300mg weekly subcutaneous injection | Drug | Open Label dupilumab |
Primary outcome
Histologic Response to Dupilumab
Time frame: 24 weeks
Proportion (percentage) of patients with histologic response, defined as <15 eosinophils per high-power field (eos/hpf), after 24 weeks of dupilumab 300mg weekly.
4 secondary outcomes
Change in Minimum Esophageal Caliber
Time frame: 24 weeks
Decrease in Number of Dilations
Time frame: 52 weeks
Change in Endoscopic Severity
Time frame: 24 weeks
Change in Histologic Severity
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evan S Dellon, MD, MPH principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dupilumab in people with Eosinophilic Esophagitis and EoE, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histologic Response to Dupilumab (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.