A Phase 4 interventional study of Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT] in Eosinophilic Esophagitis (EoE), sponsored by University of California, San Diego. Recruiting at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2024-12-11.
Sponsored by University of California, San Diego · Phase 4, Interventional, and Treatment
The goal of this study is to research Dupilumab, an FDA approved medication in treating patients diagnosed with Eosinophilic esophagitis (EoE). The drug works by controlling allergic inflammation of the esophagus. The esophagus is a food pipe that transfers food from the mouth into the stomach. Participants with EoE have dysfunction of the muscle of the esophagus (impaired peristalsis) that is not favorable for the transport function.
Main question this study aims to answer is: Whether Dupilumab helps improve muscle activity of the esophagus in participants with EOE?
Participants will:
Take Dupilumab every week for 12 weeks. Visit the clinic before and after starting the medication. Keep a diary of symptoms.
Eosinophilic esophagitis (EOE) is an allergic inflammation of the mucosa of the esophagus. One or more of the common food constituents (milk, egg, soy, wheat, peanuts, tree nuts, fish, and shellfish) in a susceptible host (people with history of atopic dermatitis or asthma) is the cause of allergic inflammation in EOE. It is a Th-2 immune cell mediated allergic inflammation that leads to infiltration of the esophageal mucosa with eosinophils (> 15/high power field/HPF), which leads to submucosal fibrosis, esophageal stricture, narrow esophageal lumen, and reduced distensibility of the esophagus. Patients present with symptoms of dysphagia, food impaction, heartburn, and other non-descript symptoms. The condition can start in childhood and continue in adulthood; however, patients may present at any age. Current incidence estimates range from 5 to 10 cases per 100,000, and current prevalence estimates range from 0.5 to 1 case per 10001. Some of the EOE patients respond to acid inhibition therapy and it may be that acid reflux is the cause of EOE in some patients.
The inflammatory damage to the esophageal epithelium results in symptoms of esophageal dysfunction, such as dysphagia. Chronic inflammation of the esophagus may also lead to remodeling, stricture formation, and fibrosis6. The fibrotic aspect of progressed disease is not well understood, and whether or not this can be reversed with treatment is unknown. Current therapeutic approaches include chronic dietary elimination, swallowed topical formulation of corticosteroids and esophageal dilation. Emergency endoscopy for prolonged and/or painful food impaction is associated with a risk of severe esophageal injury, and it does not alter the underlying pathogenesis or progression of the disease. Although swallowed topical corticosteroids have been reported in clinical trials to induce partial clinical responses and histologic remission, they are not uniformly effective and can be associated with fungal infections as well as disease recurrence after discontinuation. Studies shows that Dupilumab, a monoclonal antibody against IL4 and IL13 is an effective treatment in patients with EOE.
Few years ago, the investigators observed an additional mechanism of dysphagia in EOE patients, which relates to the esophageal motor function. The latter is best assessed by esophageal manometry study, which is normal in the majority (80%) of EOE patients. However, esophageal manometry records only the function of inner, i.e., circular muscle layer of the esophagus, which is only 50% of the total esophageal muscles mass (muscularis propria). The other 50%, i.e., longitudinal muscle is the outer of the 2 muscle layers of the esophagus. A series of studies from my laboratory reveal that the longitudinal muscle layer is responsible for the descending relaxation of the peristaltic reflex. Descending relaxation is critical because it allows esophagus to distend and bolus to proceed in aboral direction with minimal resistance to the flow of swallowed contents. The investigators found that patients with EOE have, 1) dysfunctional longitudinal muscle which manifests as a lower amplitude of contraction as compared to normal subjects and, 2) temporal discoordination between the contractions of the two muscle layers15. Both of the above scenarios can lead to impaired descending relaxation that can results in a smaller luminal CSA of the esophagus during peristalsis as compared to normal subject, which will appear as a narrow lumen esophagus on the barium swallow study, a scenario similar to an esophageal stricture, well described in patients with EOE. A narrow lumen esophagus will result in resistance to the passage of bolus or in other words difficulty swallowing (dysphagia).
Patients with EOE have reduced distensibility of the esophagus, as measured by Endoflip technique. The Endoflip study requires placement of a bag inside the esophagus and distending it with saline to measure pressure and the bag luminal CSA. While Endoflip is an important advancement to measure the luminal CSA, it does not record distensibility under physiological condition of swallowing, i.e., swallow-induced peristalsis. Using intraluminal impedance technique, the investigators have pioneered a methodology to measure the luminal CSA during peristalsis. Using above methodology, the investigators found that in many participant groups, i.e., nutcracker esophagus, esophagogastric junction outflow obstruction and functional dysphagia, the luminal CSA during peristalsis is significantly smaller as compared to normal healthy subjects. The luminal CSA ahead of contraction during peristalsis is an indirect measure of the descending relaxation of the peristaltic reflex. Recent studies published in the New England Journal of Medicine and Gastroenterology show that a 24-week treatment with Dupilumab leads to an approximately 50% reduction in dysphagia symptoms, >90% reduction in the eosinophil count, 70% reduction in the histologic scoring system and 18% improvement in the esophageal distensibility. The goal of the study is to determine if treatment with Dupilumab will result in reversal of the longitudinal muscle dysfunction during peristalsis seen in patients with EOE.
The Dupilumab is an FDA approved study for the treatment of EOE. The current investigation is not intended to support, 1) a significant change in the advertising for the drug, 2) does not involve a change of route of administration, dose, participant population, or other factor that significantly increases the risk (or decreases the acceptability of the risk) associated with the use of the drug product. The investigation will be conducted in compliance with the requirements for review by an IRB and with the requirements for informed consent. 3) A previously reported study has showed a significant inflammation reduction in 60% EoE patients when taking Dupilumab for 12 weeks. This study aims to study its effects on restoring peristalsis in EoE participants when taken for 12 weeks. 4) Participants after study completion will be continuing standard treatment guidelines as indicated by the study PI or participant's physician.
235 studies on the registry are indexed under Eosinophilic Esophagitis; 53 are open to participants now.
This study's planned enrollment of 30 is below the median of 42 across 134 interventional studies indexed under Eosinophilic Esophagitis.
Browse Eosinophilic Esophagitis studies →University of California, San Diego is the lead sponsor of 980 studies on the registry; 195 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 71 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Exclusion Criteria:
Participants will be excluded from the study if they have any of the followings:
Any of the following abnormal lab values at screening:
Heterosexual women of who are unwilling to practice highly effective prior to the initial dose/start of the first treatment, during the study, and for at least 12 weeks after the last dose. Highly effective contraceptive measures include:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All the participants will be treated with once a week subcutaneous injection of Dupilumab 300 mg through for 12 weeks. There is no placebo arm in the study.
Drug: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]
Drug page: Dupilumab
Dosage form: Subcutaneous injection Dosage: 300 mg/ 2ml Dosage frequency: Once a week Duration: 12 weeks
To determine the change in the peak esophageal muscle thickness during peristalsis following 12 weeks of Dupilumab
To see if there is an improvement in the longitudinal muscle dysfunction - increase in the muscle thickness (difference between baseline and at the peak of swallow-induced esophageal contraction), and peak muscle thickness at the peak of circular muscle contraction, measured in millimeters will be recorded. The investigators will make paired observation in each participant, i.e., before and after treatment with Dupilumab, and perform paired t test statistics.
Time frame: From baseline assesment at 2 weeks to the end of the study at 14 weeks
To determine the change in the esophageal luminal cross-sectional area ( measured in mm2) following treatment with Dupilumab
To see if there is an increase in the luminal cross-sectional area during peristalsis (measured in mm2) following treatment, which will be assessed by the impedance recording. The investigators expect a statistically significant increase in luminal cross-sectional area during peristalsis following treatment with Dupilumab.
Time frame: From baseline assesment at 2 weeks to the end of treatment at 14 weeks
To determine the differences in amplitude of longitudinal muscle contraction in EOE participants who have reduction in eosinophil count < 6 HPF, compared to the one with eosinophil count > 6HPF following 12 weeks treatment with Dupilumab
To measure whether there is a statistically significant difference in the amplitude of longitudinal muscle contraction (peak muscle thickness or the difference between baseline and peak muscle thickness measured in mm) between those EOE participants who have reduction in eosinophil count of \< 6 HPF, as compared to the one with eosinophil count of \> 6HPF, following 12 weeks of treatment with Dupilumab. Participants with eosinophils \< 6HPF should have greater improvement compared to participants with \>6 HPF
Time frame: From week 2 till the end of the study at 12 weeks
To determine the differences in the luminal CSA during peristalsis following 12 weeks of treatment with Dupilumab in EOE participants who have reduction in the eosinophil count of < 6 HPF as compared to the one with eosinophil count of > 6HPF.
To see if there is a statistically significant differences in the luminal CSA (measured in mm2) during peristalsis following 12 weeks of treatment with Dupilumab in those EOE participants who have reduction in the eosinophil count of \< 6 HPF as compared to the one with eosinophil count of \> 6HPF.
Time frame: From baseline assesment at week 2 to the study end date at 12 weeks.
Plan to share: Undecided — Plans to share the de-identified IPD will be considered at the end of the study on the basis of the study results.
Started Nov 2024 (actual). Primary completion is estimated for Sep 2026, 22 months after the start.
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