| Eligibility |
Inclusion Criteria:
1. Age 18 to 75 years old, inclusive, at the time of signing the informed consent form.
2. Documented diagnosis of EoE by endoscopy prior to screening. Note: Must include a
demonstration of intraepithelial eosinophilic infiltration (peak cell count = 15
eos/hpf [400×]) from esophageal biopsy specimens from endoscopy.
3. History (by participant report) of on average at least 2 episodes of dysphagia (with
intake of solids off anti-inflammatory therapy) per week in the 4 weeks prior to
screening, and on average at least 2 episodes of documented dysphagia per week during
any 2 consecutive weeks (qualifying period) between screening and baseline; dysphagia
is defined as trouble swallowing solid food, or having solid food stick, by
participant report; and completed the DSQ on = 70% of days during the qualifying
period prior to baseline (Visit 1).
4. Must remain on a stabilized diet for at least 6 weeks prior to screening and during
the course of the study; stable diet is defined as no initiation of single or multiple
elimination diets or reintroduction of previously eliminated food groups.
5. Must be willing and able to continue any dietary therapy and/or medical regimens
(including gastric acid suppression) in effect at the screening visit. There should be
no change to these regimens during the study participation.
6. Willing and able to comply with all clinic visits and study-related procedures.
7. Able to understand and complete study-related questionnaires.
8. Provide signed informed consent.
9. Esophagogastroduodenoscopy (EGD) with photographs performed at screening (qualifying
EGD), with a demonstration of intraepithelial eosinophilic infiltration (peak cell
count =15 eos/hpf) in at least 2 of the 3 biopsied esophageal regions (proximal, mid,
or distal).
Exclusion Criteria:
1. Prior participation in an IRL201104 clinical study.
2. Has any current disease of the gastrointestinal tract (aside from EoE) that may
impact, in the investigator's opinion, the patient's EoE disease status. This
includes, but not limited to: eosinophilic gastritis, eosinophilic enteritis,
eosinophilic duodenitis, eosinophilic colitis, or proctitis; inflammatory bowel
disease; or celiac disease.
3. Has other causes of esophageal eosinophilia or the following diseases:
hypereosinophilic syndromes, Churg-Strauss vasculitis (eosinophilic granulomatosis
with polyangiitis), or peripheral blood absolute eosinophil count of > 1500
eosinophils/µL.
4. Has presence of oral or esophageal mucosal infection of any type.
5. Has any condition affecting the esophageal mucosa or altering esophageal motility
other than EoE.
6. History of achalasia, active Helicobacter pylori infection, Crohn's disease,
ulcerative colitis, celiac disease, and prior esophageal surgery (with the exception
of a surgical repair of an EoE complication).
7. Any esophageal stricture unable to be passed with a standard, diagnostic, adult (9 to
10 mm) upper endoscope or any critical esophageal stricture that requires dilation at
screening; or dilation within 2 months prior to screening.
8. On a pure liquid diet or any mouth or dental condition that prevents normal eating.
9. Has initiated, discontinued, or changed dosage regimen of PPIs within the 4 weeks
prior to the qualifying EGD, between the qualifying EGD and baseline visit (Visit 1),
or anticipates changes in the use of PPI during the study. PPI must remain constant
throughout the study.
10. History of bleeding disorders or esophageal varices.
11. Use of anticoagulants within 2 weeks prior to screening. Participants should not stop
these agents solely to become eligible for entry into this study.
12. Treatment with an investigational drug within 2 months or within 5 half-lives (if
known), whichever is longer, prior to screening.
13. Use of systemic corticosteroids within 3 months or swallowed topical corticosteroids
within 6 weeks prior to screening.
14. Treatment with oral immunotherapy (OIT) within 6 months prior to screening.
15. Allergen immunotherapy (sublingual immunotherapy [SLIT] and/or subcutaneous
immunotherapy [SCIT]), unless on a stable dose for at least 1 year prior to screening.
16. The following treatments within 3 months before the screening visit, or any condition
that, in the opinion of the investigator, is likely to require such treatment(s)
during the study:
Systemic immunosuppressive/immunomodulating drugs (eg, omalizumab, cyclosporine,
mycophenolate-mofetil, interferon [IFN]?, Janus kinase inhibitors, azathioprine,
methotrexate, and other biologics that are ongoing [eg, dupilumab, benralizumab,
mepolizumab, or vedolizumab]).
17. Diagnosed with active parasitic infection; or suspected parasitic infection, unless
clinical and (if necessary) laboratory assessments have ruled out active infection
before randomization.
18. Chronic or acute infection requiring treatment with systemic antibiotics, antivirals,
or antifungals within 1 month prior to screening.
19. Use of oral antibiotics/anti-infectives within 2 weeks prior to screening.
20. Known or suspected immunosuppression, including history of invasive opportunistic
infections (eg, tuberculosis, non-tuberculous mycobacterial infections,
histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis)
despite infection resolution, or otherwise recurrent infections of abnormal frequency,
or prolonged infections suggesting an immunocompromised status, as judged by the
investigator.
21. Known history of human immunodeficiency virus (HIV) infection.
22. Positive or indeterminate hepatitis B surface antigen (HBsAg) or hepatitis C antibody
at screening.
23. Moderate or severe renal impairment (eGFR <60 mL/min/1.73 m2) or end stage renal
disease.
24. Elevated transaminases (alanine aminotransferase [ALT] and/or aspartate
aminotransferase [AST]) > 3 times the upper limit of normal (ULN) at screening.
25. History of malignancy within 5 years prior to screening, except completely treated in
situ carcinoma of the cervix and completely treated and resolved nonmetastatic
squamous or basal cell carcinoma of the skin.
26. Any other medical or psychological condition including relevant laboratory
abnormalities at screening that, in the opinion of the investigator, suggest a new
and/or insufficiently understood disease, may present an unreasonable risk to the
participant as a result of his/her participation in this clinical study, may make the
participant's participation unreliable, or may interfere with study assessments. The
specific justification for participants excluded under this criterion will be noted in
study documents (eg, chart notes, electronic case report form). These may include
participant-reported alcohol or drug abuse and severe concomitant illness(es).
27. Planned or anticipated use of any prohibited medications and procedures (as described
in the exclusion criteria) during study treatment.
28. Treatment with a live (attenuated) vaccine within 3 months prior to screening and/or
treatment of a killed vaccine within 30 days prior to screening, until the end of the
study with the exception of a coronavirus disease of 2019 (COVID-19) vaccine, as
described in Section 9.2.1.
29. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed
during the study.
30. Women unwilling to use adequate birth control, if of reproductive potential* and
sexually active. Adequate birth control is defined as agreement to consistently
practice an effective and accepted method of contraception throughout the duration of
the study and for 30 days after the last dose of study treatment. These include:
hormonal contraceptives, intrauterine device, or double barrier contraception (ie,
condom and diaphragm), or male partner with documented vasectomy.
- For females, menopause is defined as at least 12 consecutive months without
menses; to include laboratory confirmation of post-menopausal status (ie, a
follicle stimulating hormone (FSH) of 2.25 U/mL must be documented).
Hysterectomy, bilateral oophorectomy, or bilateral tubal ligation must be
documented, as applicable; if documented, women with these conditions are not
required to use additional contraception.
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