Eosinophilic EsophagitisPhase 2DeTECTSNCT06705387
Dupilumab Versus Topical Corticosteroid Effectiveness - Comparison in the Treatment of Stenotic EoE
A Phase 2 study testing Dupilumab and Fluticasone in people with Eosinophilic Esophagitis, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The goal of this clinical trial is to [primary purpose: e.g., learn if intervention or health behavior can treat, prevent, diagnose etc.] in [describe participant population/primary condition; could include any of the following: sex/gender, age groups, healthy volunteers]. Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Dupilumab and Fluticasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2024to Mar 2027
- Phase
- Phase 2
- 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 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Seen at CHCO for clinical care.
- Age 12 - 25 years old inclusive
- Weight ≥40 kg at the time of screening visit
- Confirmed EoE as diagnosed by biopsy with eosinophils ≥15 eosinophils/hpf in at least 2 esophageal regions at screening endoscopy
- Report of an average of at least 2 episodes of dysphagia per week in the 4 weeks prior to screening.
- Evidence of fibrostenotic features at time of screening endoscopy (grade 2 or 3 esophageal rings, stricture, delayed passage of barium tablet on fluoroscopy, and/or distensibility ≤15mm)
Who cannot join
- Esophageal dilation performed at index endoscopy
- Patients with stricture undergoing dilation at index endoscopy may be rescreened if they meet all other eligibility criteria.
- Patients with acute food impaction will not be enrolled at their therapeutic endoscopy but are eligible for enrollment subsequently if they meet all other eligibility criteria.
- Eligible patients on current STCs can be enrolled but need to be on stable dosing less than or equal to 440 mcg two times daily fluticasone equivalent for 3 months prior to enrollment.
- Patients who have received dupilumab in the past 12 months for any indication are excluded.
- Diet restrictions and PPI use must stay unchanged in the 8 weeks prior to index endoscopy and through the study period.
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- Patients with a fasting morning cortisol <5 within 2 months of screening will not be enrolled. If repeat cortisol levels are normal, patients can be reconsented.
- Known other esophageal disease or esophageal injury (e.g. achalasia, tracheoesophageal fistula, congenital stricture, caustic injury, history of esophageal surgery), inflammatory bowel disease, liver disease, connective tissue disorder, or bleeding disorder.
- Patients with a known gelatin allergy will be excluded from EST collection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Colorado/University of Colorado School of Medicine
Aurora, Colorado, 80045
Clinical Research Supervisor | Digestive Health Institute, 720-777-8884, michelle.landis@childrenscolorado.org
About this study
Official title: DeTECTS: Dupilumab Versus Topical Corticosteroid Effectiveness - Comparison in the Treatment of Stenotic EoE
The goal of this clinical trial is to [primary purpose: e.g., learn if intervention or health behavior can treat, prevent, diagnose etc.] in [describe participant population/primary condition; could include any of the following: sex/gender, age groups, healthy volunteers]. The main question[s] it aims to answer [is/are]:
Does dupilumab or swallowed topical fluticasone improve the diameter of the esophagus more? Does dupilumab or swallowed topical fluticasone reduce inflammation in the esophagus more? Are comparative effective clinical trials feasible in this patient population?
Read more
Researchers will compare dupilumab 300 mg weekly compared to swallowed fluticasone to see if there is a difference in treatment response.
Participants will be asked to:
- Be randomized to either dupilumab sq weekly or swallowed topical fluticasone twice daily.
- Participate in 8 study visits over 52 weeks
- Complete questionnaires
- Have an endoscopy with biopsies and EndoFLIP measurements.
- Swallow an Esophageal String Test
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Dupilumab, Fluticasone
- Keywords
- Dupilumab, Fluticasone
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabBiological
Also called Dupixent
Subcutaneous injection of 300mg per week for 16 weeks.
FluticasoneDrug
Also called Flovent
Metered dose swallowed topical corticosteroid, given 1760mcg per day for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| dupilumab (also known as Dupixent) | Active comparator | Not described Receives: Biological: Dupilumab |
| fluticasone (also known as Flovent) | Active comparator | Not described Receives: Drug: Fluticasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophageal Lumen Distensibility
Change in distensibility (mm) from baseline to end of treatment (continuous). This is measured by EndoFLIP.
Measured: From baseline endoscopy to the end of treatment at week 16.
Reduction of epithelial eosinophilia to < 15 eos/hpf (binary)
The number of patients meeting a reduction in epithelial eosinophilia on esophageal biopsies of <15 eos/hpf at end of treatment.
Measured: This will be measured at week 16 end of treatment.
Secondary outcomes (1)
Change in daily symptom questionnaire (DSQ) severity score
The change in daily symptoms as measured by the DSQ severity score from enrollment to end of treatment at week 16. A possible DSQ score can range between 0 and 84.
Measured: From screening to the end of treatment at week 16.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start23 Dec 2024
- Primary completionSep 2026 (estimated)
- Study completionMar 2027 (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 Colorado, DenverThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705387
- Sponsor's protocol ID
- 23-2367
- Other IDs
- 1R01DK135692-01A1
- Acronym
- DeTECTS
- Status last verified
- Mar 2025
- First submitted
- 29 Jul 2024
- Last updated
- 14 Mar 2025
- 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 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DeTECTS: Dupilumab Versus Topical Corticosteroid Effectiveness - Comparison in the Treatment of Stenotic EoE
- ClinicalTrials.gov ID
- NCT06705387
- Acronym / sponsor ID
- DeTECTS / 23-2367
- Conditions
- Eosinophilic Esophagitis
- Keywords
- Dupilumab, Fluticasone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 26 Nov 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 goal of this clinical trial is to [primary purpose: e.g., learn if intervention or health behavior can treat, prevent, diagnose etc.] in [describe participant population/primary condition; could include any of the following: sex/gender, age groups, healthy volunteers]. The main question[s] it aims to answer [is/are]:
Does dupilumab or swallowed topical fluticasone improve the diameter of the esophagus more? Does dupilumab or swallowed topical fluticasone reduce inflammation in the esophagus more? Are comparative effective clinical trials feasible in this patient population?
Researchers will compare dupilumab 300 mg weekly compared to swallowed fluticasone to see if there is a difference in treatment response.
Participants will be asked to:
- Be randomized to either dupilumab sq weekly or swallowed topical fluticasone twice daily.
- Participate in 8 study visits over 52 weeks
- Complete questionnaires
- Have an endoscopy with biopsies and EndoFLIP measurements.
- Swallow an Esophageal String Test
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dupilumab (also known as Dupixent) | Active comparator | Biological: Dupilumab |
| fluticasone (also known as Flovent) | Active comparator | Drug: Fluticasone |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Seen at CHCO for clinical care.
- Age 12 - 25 years old inclusive
- Weight ≥40 kg at the time of screening visit
- Confirmed EoE as diagnosed by biopsy with eosinophils ≥15 eosinophils/hpf in at least 2 esophageal regions at screening endoscopy
- Report of an average of at least 2 episodes of dysphagia per week in the 4 weeks prior to screening.
Key exclusion criteria (9 listed)
- Esophageal dilation performed at index endoscopy
- Patients with stricture undergoing dilation at index endoscopy may be rescreened if they meet all other eligibility criteria.
- Patients with acute food impaction will not be enrolled at their therapeutic endoscopy but are eligible for enrollment subsequently if they meet all other eligibility criteria.
- Eligible patients on current STCs can be enrolled but need to be on stable dosing less than or equal to 440 mcg two times daily fluticasone equivalent for 3 months prior to enrollment.
- Patients who have received dupilumab in the past 12 months for any indication are excluded.
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: DupixentSubcutaneous injection of 300mg per week for 16 weeks. | Biological | dupilumab (also known as Dupixent) |
| FluticasoneAlso: FloventMetered dose swallowed topical corticosteroid, given 1760mcg per day for 16 weeks. | Drug | fluticasone (also known as Flovent) |
Primary outcome
Esophageal Lumen Distensibility
Time frame: From baseline endoscopy to the end of treatment at week 16.
Change in distensibility (mm) from baseline to end of treatment (continuous). This is measured by EndoFLIP.
Reduction of epithelial eosinophilia to < 15 eos/hpf (binary)
Time frame: This will be measured at week 16 end of treatment.
The number of patients meeting a reduction in epithelial eosinophilia on esophageal biopsies of <15 eos/hpf at end of treatment.
1 secondary outcome
Change in daily symptom questionnaire (DSQ) severity score
Time frame: From screening to the end of treatment at week 16.
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 14 Mar 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dupilumab and Fluticasone in people with Eosinophilic Esophagitis, run by University of Colorado, Denver 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?
The sponsor lists 6 inclusion and 9 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 14 Mar 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Michelle Landis, BS (720-777-8884, michelle.landis@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esophageal Lumen Distensibility (time frame: From baseline endoscopy to the end of treatment at week 16.). The study lists 2 primary outcomes in all. 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 14 Mar 2025.