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A Study to Investigate the Efficacy and Tolerability of ESO-101 in Patients With Eosinophilic Esophagitis

Study Purpose

This is a randomized, placebo-controlled, double-blind trial to evaluate the efficacy, tolerability, and safety of ESO-101 in adult patients with active eosinophilic esophagitis (EoE). Patients will be screened at 2 visits (Visit 1 and Visit 2) during which their eligibility will be assessed based on endoscopy-independent criteria (Visit 1) and based on the histologic assessment of esophageal biopsy samples taken during the screening endoscopy (Visit 2). Eligible patients will be randomized 2:1 to once-daily treatment with ESO-101 or placebo and treated for 28 days starting on Day 0. Further clinic visits will be performed at Day 14 (Visit 4) and Day 28 (Visit 5, end of treatment) to assess the efficacy, tolerability, and safety. In addition, a safety follow-up call will be scheduled 2 weeks after the end of treatment (Day 42, Visit 6).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Adult patients aged 18-70 years; 2. Confirmed clinicopathological diagnosis of EoE (eosinophilic esophagitis); 3. Active and symptomatic EoE, defined as: 1. peak eosinophil count ≥15 eosinophils/high-powered field (hpf) at 2 levels of the esophagus at the screening endoscopy (Visit 2) as measured in a total of 6 hpfs derived from 6 biopsies, 2 each from the proximal, mid, and distal segment of the esophagus; 2. either a dysphagia or odynophagia severity sore of ≥4 on a 11-point numeric rating scale for ≥1 day during the 7 days before Screening (Visit 1); 4. Written informed consent; 5. Willingness and ability to comply with the protocol for the duration of the trial; 6. Negative pregnancy test at Screening (Visit 1) and Day 0 (Visit 3) in women of childbearing potential (i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy); 7. Women of childbearing potential must be willing to use (for a least 3 monthly cycles before the screening endoscopy [Visit 2] and until 4 weeks after the last intake of IMP) a highly effective method of contraception or birth control (failure rate less than 1% per year when used consistently and correctly). Reliable methods for this trial are: 1. combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); 2. progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); 3. intrauterine device or intrauterine hormone-releasing system; 4. bilateral tubal occlusion; 5. a vasectomized sexual partner; 6. sexual abstinence (only accepted as true abstinence when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods, and withdrawal] is not an acceptable method of contraception).

Exclusion Criteria:

1. Women who are pregnant, lactating, possibly pregnant or planning a pregnancy during the trial period; 2. Current or past (within the last 3 months) alcohol or drug abuse; 3. Initiation of a diet-modifying food restriction within 4 weeks before the screening endoscopy (Visit 2) until EOT (end of treatment); 4. Use of systemic corticosteroids or biologic immunomodulators within 3 months before the screening endoscopy (Visit 2) until the EOT; 5. History of non-response to treatment of EoE with topical corticosteroid drugs (defined as no improvement of clinical symptoms of EoE after a minimum of 4 weeks corticosteroid therapy used at appropriate doses according to the investigator's judgment) or requirement of cessation of corticosteroid therapy for EoE treatment due to oral candidiasis or systemic corticosteroid side effects; 6. Use of corticosteroids for treatment of EoE within 4 weeks before the screening endoscopy (Visit 2) until the EOT; 7. Use of inhalable (pulmonary or nasal) corticosteroids within 4 weeks before the screening endoscopy (Visit 2) until the EOT; 8. Asthma requiring corticosteroid therapy in the seasonal allergy period according to the investigator's judgment based on anamnesis until the EOT; 9. Change in proton pump inhibitor (PPI) dosing regimen within 4 weeks before the screening endoscopy (Visit 2) until the EOT; 10. Use of systemic leukotriene receptor antagonists, immunosuppressant therapy, or chronic oral or systemic anticoagulants (such as coumarin derivates, novel oral and subcutaneous anticoagulants) within 2 weeks before Screening (Visit 1) until the EOT; 11. Unable to swallow a test tablet of about the size of the IMP capsule used in the trial; 12. History of diabetes mellitus; 13. Other severe comorbid condition, concurrent medication, or other issue that renders the patient unsuitable to participate in the trial in the judgment of the investigator, including but not limited to: comorbid condition with an estimated life expectancy of ≤12 months, dialysis, severe pulmonary (requiring home oxygen, uncontrolled chronic obstructive pulmonary disease Gold III/IV) or cardiovascular conditions (heart failure New York Heart Association III and IV, uncontrolled hypertension systolic blood pressure by repeated measurement >180mmHg); 14. History of cancer (except non-melanoma skin cancer, or carcinoma in situ of cervix) or treatment with anticancer therapy (chemotherapy, immunotherapy, radiotherapy, hormone therapy for cancer treatment, targeted therapy or gene therapy) within 12 months before Screening (Visit 1) until the EOT; 15. Known intolerability or hypersensitivity to mometasone furoate or any of the IMP excipients (e.g. bovine gelatin, polyvinyl alcohol, polyvinyl acetate, glycerol, sorbitol); 16. Systemic autoimmune disorders or any condition requiring immunosuppression (e.g. methotrexate, cyclosporine, interferon alpha, tumor necrosis factor alpha inhibitors, antibodies to immunoglobulin E) within 3 months before Screening (Visit 1); 17. Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the trial or presence of any condition that impacts compliance with the trial procedures; 18. Use of any investigational or non-registered product (medicinal product or medical device) within 4 weeks before the screening endoscopy (Visit 2) until the EOT; 19. Employee at the trial center, spouse, partner or child of investigators or sub-investigators or employee of the sponsor. 20. History of or active eosinophilic gastroenteritis and colitis, inflammatory bowel disease, celiac disease, oral or esophageal mucosal infection of any kind, and esophageal varices; 21. Gastroesophageal reflux disease with Los Angeles Grade B or higher, or erosive esophagitis Grade 2 or above; 22. Presence of Barrett's esophagus with a maximum length of ≥3 cm with intestinal metaplasia or dysplasia, peptic stricture, achalasia, significant hiatal hernia >3 cm, esophageal scleroderma, or diagnosis of Lichen planus; 23. Emergency endoscopy for bolus impaction within 2 weeks before Screening (Visit 1); 24. Any mouth or dental condition that prevents normal eating; 25. History of (dilation within the previous 8 weeks) or current severe endoscopic structural abnormality in esophagus (e.g. high-grade stenosis where an 8-10 mm endoscope cannot pass without dilatation at the screening endoscopy [Visit 2]); 26. Diagnosed liver cirrhosis or portal hypertension; 27. History of upper gastrointestinal bleeding within 8 weeks before Screening (Visit 1); 28. Known allergy to β-lactoglobulin (cow milk protein).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

EsoCap AG
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Isabelle Racamier
Principal Investigator Affiliation EsoCap AG (Malzgasse 9, 4052 Basel, Switzerland)
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry, Other
Overall Status Active, not recruiting
Countries Germany, Netherlands, Poland, Spain, Switzerland

The disease, disorder, syndrome, illness, or injury that is being studied.

Eosinophilic Esophagitis
Arms & Interventions


Experimental: ESO-101

Oral use of 1 hard gelatin capsule (800 μg)

Placebo Comparator: Placebo

Oral use of 1 hard gelatin capsule


Drug: - ESO-101

Daily administration in the evening at bedtime for 28 days

Drug: - Placebo

Daily administration in the evening at bedtime for 28 days

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Facharztzentrum Eppendorf, Hamburg, Germany



Facharztzentrum Eppendorf

Hamburg, ,

Universitätsklinikum Leipzig AöR, Leipzig, Germany



Universitätsklinikum Leipzig AöR

Leipzig, ,

Magdeburg, Germany



Otto-von-Guericke-Universität Medizinische Fakultät Universitätsklinikum Magdeburg A. ö. R.

Magdeburg, ,

Klinikum rechts der Isar der TUM, München, Germany



Klinikum rechts der Isar der TUM

München, ,

Amsterdam University Medical Center, Amsterdam, Netherlands



Amsterdam University Medical Center

Amsterdam, ,

Albert Schweitzer Ziekenhuis, Dordrecht, Netherlands



Albert Schweitzer Ziekenhuis

Dordrecht, ,

Centrum Medyczne Sonomed Sp. z o.o., Szczecin, Poland



Centrum Medyczne Sonomed Sp. z o.o.

Szczecin, ,

Centrum Medyczne Med-GASTR Sp. z o.o., Łódź, Poland



Centrum Medyczne Med-GASTR Sp. z o.o.

Łódź, ,

Hospital Universitario Vall d' Hebrón, Barcelona, Spain



Hospital Universitario Vall d' Hebrón

Barcelona, ,

Hospital Universitario de La Princesa, Madrid, Spain



Hospital Universitario de La Princesa

Madrid, ,

Madrid, Spain



Hospital Universitario Fundación Jiménez Díaz

Madrid, ,

Oviedo, Spain



Hospital Universitario Central De Asturias

Oviedo, ,

Hospital de Navarra, Pamplona, Spain



Hospital de Navarra

Pamplona, ,

Hospital General de Tomelloso, Tomelloso, Spain



Hospital General de Tomelloso

Tomelloso, ,

Hospital Universitario Rio Hortega, Valladolid, Spain



Hospital Universitario Rio Hortega

Valladolid, ,

Hospital de Viladecans, Viladecans, Spain



Hospital de Viladecans

Viladecans, ,

Universitätsspital Zürich, Zürich, Switzerland



Universitätsspital Zürich

Zürich, ,

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