Eosinophilic EsophagitisPhase 2NCT04849390
A Study to Investigate the Efficacy and Tolerability of ESO-101 in Patients With Eosinophilic Esophagitis
A Phase 2 study testing ESO-101 in people with Eosinophilic Esophagitis, run by EsoCap AG at 17 sites in 5 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- ESO-101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 17 sitesin 5 countries
- Study dates
- 29 Jun 2021to 9 Oct 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18-70 years;
- Confirmed clinicopathological diagnosis of EoE (eosinophilic esophagitis);
- Active and symptomatic EoE, defined as:
- 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;
- 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);
- Written informed consent;
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- Willingness and ability to comply with the protocol for the duration of the trial;
- 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);
- 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:
- combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal);
- progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable);
- intrauterine device or intrauterine hormone-releasing system;
- bilateral tubal occlusion;
- a vasectomized sexual partner;
- 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).
Who cannot join
- Women who are pregnant, lactating, possibly pregnant or planning a pregnancy during the trial period;
- Current or past (within the last 3 months) alcohol or drug abuse;
- Initiation of a diet-modifying food restriction within 4 weeks before the screening endoscopy (Visit 2) until EOT (end of treatment);
- Use of systemic corticosteroids or biologic immunomodulators within 3 months before the screening endoscopy (Visit 2) until the EOT;
- 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;
- Use of corticosteroids for treatment of EoE within 4 weeks before the screening endoscopy (Visit 2) until the EOT;
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- Use of inhalable (pulmonary or nasal) corticosteroids within 4 weeks before the screening endoscopy (Visit 2) until the EOT;
- Asthma requiring corticosteroid therapy in the seasonal allergy period according to the investigator's judgment based on anamnesis until the EOT;
- Change in proton pump inhibitor (PPI) dosing regimen within 4 weeks before the screening endoscopy (Visit 2) until the EOT;
- 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;
- Unable to swallow a test tablet of about the size of the IMP capsule used in the trial;
- History of diabetes mellitus;
- 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);
- 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;
- Known intolerability or hypersensitivity to mometasone furoate or any of the IMP excipients (e.g. bovine gelatin, polyvinyl alcohol, polyvinyl acetate, glycerol, sorbitol);
- 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);
- 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;
- 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;
- Employee at the trial center, spouse, partner or child of investigators or sub-investigators or employee of the sponsor.
- History of or active eosinophilic gastroenteritis and colitis, inflammatory bowel disease, celiac disease, oral or esophageal mucosal infection of any kind, and esophageal varices;
- Gastroesophageal reflux disease with Los Angeles Grade B or higher, or erosive esophagitis Grade 2 or above;
- 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;
- Emergency endoscopy for bolus impaction within 2 weeks before Screening (Visit 1);
- Any mouth or dental condition that prevents normal eating;
- 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]);
- Diagnosed liver cirrhosis or portal hypertension;
- History of upper gastrointestinal bleeding within 8 weeks before Screening (Visit 1);
- Known allergy to β-lactoglobulin (cow milk protein).
Trial locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
Spain8 sites
Hospital Universitario Vall d' Hebrón
Barcelona
Hospital Universitario de La Princesa
Madrid
Hospital Universitario Fundación Jiménez Díaz
Madrid
Hospital Universitario Central De Asturias
Oviedo
Hospital de Navarra
Pamplona
Hospital General de Tomelloso
Tomelloso
Hospital Universitario Rio Hortega
Valladolid
Hospital de Viladecans
Viladecans
Germany4 sites
Facharztzentrum Eppendorf
Hamburg
Universitätsklinikum Leipzig AöR
Leipzig
Otto-von-Guericke-Universität Medizinische Fakultät Universitätsklinikum Magdeburg A. ö. R.
Magdeburg
Klinikum rechts der Isar der TUM
München
Netherlands2 sites
Amsterdam University Medical Center
Amsterdam
Albert Schweitzer Ziekenhuis
Dordrecht
Poland2 sites
Centrum Medyczne Med-GASTR Sp. z o.o.
Lodz
Centrum Medyczne Sonomed Sp. z o.o.
Szczecin
About this study
Official title: A Randomized, Placebo-controlled, Double-blind Trial Evaluating the Efficacy, Tolerability and Safety of ESO-101 in Adult Patients With Active Eosinophilic Esophagitis
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).
- Conditions
- Eosinophilic Esophagitis
- Being tested
- ESO-101, Placebo
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESO-101Drug
Also called Mometasone furoate (800 μg)
Daily administration in the evening at bedtime for 28 days
PlaceboDrug
Daily administration in the evening at bedtime for 28 days
| Study group | Role | What they receive |
|---|---|---|
| ESO-101 | Experimental | Oral use of 1 hard gelatin capsule (800 μg) Receives: Drug: ESO-101 |
| Placebo | Placebo comparator | Oral use of 1 hard gelatin capsule Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in peak eosinophil count from Baseline to end of treatment
The processing and analysis of biopsy samples taken at Visit 2 and end of treatment (Visit 5) will be performed blinded at a central laboratory according to a laboratory manual. At both visits, 6 biopsy samples will be taken, 2 each from the proximal, mid, and distal segment of the esophagus. Histology results of the biopsies at Visit 2 will be considered baseline values. For the peak number of eosinophils, hematoxylin and eosin stained esophageal biopsy specimen will be assessed and the high-powered fields with the highest density of eosinophils will be counted.
Measured: From Baseline (Visit 2) to end of treatment (Visit 5 = 4-7 weeks after Visit 2)
Secondary outcomes (18)
Proportion of patients with histological remission, defined as the reduction of peak eosinophil count in all esophageal samples to <15 eosinophils/hpf at end of treatment, overall and determined differentially in each of the 3 esophageal segments
Biopsy samples will be taken at Visit 2 and end of treatment (Visit 5). At both visits, 6 biopsy samples will be taken, 2 each from the proximal, mid, and distal segment of the esophagus. Histology results of the biopsies at Visit 2 will be considered baseline values. For the peak number of eosinophils, hematoxylin and eosin stained esophageal biopsy specimen will be assessed and the high-powered fields (hpfs) with the highest density of eosinophils will be counted.
Measured: From Baseline (Visit 2) to end of treatment (Visit 5 = 4-7 weeks after Visit 2)
Proportion of patients with a peak eosinophil count in all esophageal samples of <6 eosinophils/hpf at end of treatment, overall and determined differentially in each of the 3 esophageal segments
Biopsy samples will be taken at Visit 2 and end of treatment (Visit 5). At both visits, 6 biopsy samples will be taken, 2 each from the proximal, mid, and distal segment of the esophagus. Histology results of the biopsies at Visit 2 will be considered baseline values. For the peak number of eosinophils, hematoxylin and eosin stained esophageal biopsy specimen will be assessed and the high-powered fields (hpfs) with the highest density of eosinophils will be counted.
Measured: End of treatment (Visit 5 = day 28)
Proportion of patients with an improvement in the dysphagia severity score from Baseline to end of treatment
Patients will rate the dysphagia severity score daily on a 11-point NRS (numeric rating scale): 0 = 'no symptoms' to 10 = 'worst possible symptoms'. At Visit 3 (Day 0) and Visit 5 (end of treatment), the worst severity scores out of the 7 days preceding the respective visit will be used for the assessment. The score assessed at Visit 3 (Day 0) at the center before IMP intake will serve as baseline score. Patients will additionally assess the severity score of the actual day in the patient diary daily after IMP intake starting on Day 0.
Measured: From Baseline (Visit 3) to end of treatment (Visit 5 = 28 days after Visit 3)
Absolute change in mean eosinophil count from Baseline to end of treatment
The processing and analysis of biopsy samples taken at Visit 2 and end of treatment (Visit 5) will be performed blinded at a central laboratory according to a laboratory manual. At both visits, 6 biopsy samples will be taken, 2 each from the proximal, mid, and distal segment of the esophagus. Histology results of the biopsies at Visit 2 will be considered baseline values. For the peak number of eosinophils, hematoxylin and eosin stained esophageal biopsy specimen will be assessed and the high-powered fields with the highest density of eosinophils will be counted.
Measured: From Baseline (Visit 2) to end of treatment (Visit 5 = 4-7 weeks after Visit 2)
Relative change in mean eosinophil count from Baseline to end of treatment
The processing and analysis of biopsy samples taken at Visit 2 and end of treatment (Visit 5) will be performed blinded at a central laboratory according to a laboratory manual. At both visits, 6 biopsy samples will be taken, 2 each from the proximal, mid, and distal segment of the esophagus. Histology results of the biopsies at Visit 2 will be considered baseline values. For the peak number of eosinophils, hematoxylin and eosin stained esophageal biopsy specimen will be assessed and the high-powered fields with the highest density of eosinophils will be counted.
Measured: From Baseline (Visit 2) to end of treatment (Visit 5 = 4-7 weeks after Visit 2)
Proportion of patients with a relative reduction in peak eosinophil count of ≥30 percent from Baseline to end of treatment
The processing and analysis of biopsy samples taken at Visit 2 and end of treatment (Visit 5) will be performed blinded at a central laboratory according to a laboratory manual. At both visits, 6 biopsy samples will be taken, 2 each from the proximal, mid, and distal segment of the esophagus. Histology results of the biopsies at Visit 2 will be considered baseline values. For the peak number of eosinophils, hematoxylin and eosin stained esophageal biopsy specimen will be assessed and the high-powered fields with the highest density of eosinophils will be counted.
Measured: From Baseline (Visit 2) to end of treatment (Visit 5 = 4-7 weeks after Visit 2)
Proportion of patients with a relative reduction in peak eosinophil count of ≥50 percent from Baseline to end of treatment
The processing and analysis of biopsy samples taken at Visit 2 and end of treatment (Visit 5) will be performed blinded at a central laboratory according to a laboratory manual. At both visits, 6 biopsy samples will be taken, 2 each from the proximal, mid, and distal segment of the esophagus. Histology results of the biopsies at Visit 2 will be considered baseline values. For the peak number of eosinophils, hematoxylin and eosin stained esophageal biopsy specimen will be assessed and the high-powered fields with the highest density of eosinophils will be counted.
Measured: From Baseline (Visit 2) to end of treatment (Visit 5 = 4-7 weeks after Visit 2)
Proportion of patients with a relative reduction in peak eosinophil count of ≥75 percent from Baseline to end of treatment
The processing and analysis of biopsy samples taken at Visit 2 and end of treatment (Visit 5) will be performed blinded at a central laboratory according to a laboratory manual. At both visits, 6 biopsy samples will be taken, 2 each from the proximal, mid, and distal segment of the esophagus. Histology results of the biopsies at Visit 2 will be considered baseline values. For the peak number of eosinophils, hematoxylin and eosin stained esophageal biopsy specimen will be assessed and the high-powered fields with the highest density of eosinophils will be counted.
Measured: From Baseline (Visit 2) to end of treatment (Visit 5 = 4-7 weeks after Visit 2)
Proportion of patients with histological remission AND improvement in the dysphagia severity score from Baseline to end of treatment
The processing and analysis of biopsy samples taken at Visit 2 and end of treatment (Visit 5) will be performed blinded at a central laboratory according to a laboratory manual. At both visits, 6 biopsy samples will be taken, 2 each from the proximal, mid, and distal segment of the esophagus. Additionally, patients will rate the dysphagia and odynophagia severity score daily on a 11-point NRS (numeric rating scale): 0 = 'no symptoms' to 10 = 'worst possible symptoms'. Patients will assess the severity score of the actual day in the patient diary daily after IMP intake starting on Day 0.
Measured: From Baseline (Visit 2 + 3) to end of treatment (Visit 5 = 4-7 weeks after Visit 2)
Absolute change in dysphagia and odynophagia severity scores from Baseline
Patients will rate the dysphagia and odynophagia severity score daily on a 11-point NRS (numeric rating scale): 0 = 'no symptoms' to 10 = 'worst possible symptoms'. Patients will assess the severity score of the actual day in the patient diary daily after IMP intake starting on Day 0.
Measured: From Baseline (Visit 3) to end of treatment (Visit 5 = 28 days after Visit 3)
Relative change in dysphagia and odynophagia severity scores from Baseline
Patients will rate the dysphagia and odynophagia severity score daily on a 11-point NRS (numeric rating scale): 0 = 'no symptoms' to 10 = 'worst possible symptoms'. Patients will assess the severity score of the actual day in the patient diary daily after IMP intake starting on Day 0.
Measured: From Baseline (Visit 3) to end of treatment (Visit 5 = 28 days after Visit 3)
Time to achieve symptom relief (defined as 50 percent improvement in the dysphagia or odynophagia symptoms on an NRS compared to Baseline)
Patients will rate the dysphagia and odynophagia severity score daily on a 11-point NRS (numeric rating scale): 0 = 'no symptoms' to 10 = 'worst possible symptoms'. Patients will assess the severity score of the actual day in the patient diary daily after IMP intake starting on Day 0.
Measured: From Baseline (Visit 3) to end of treatment (Visit 5 = 28 days after Visit 3)
Change in the EREFS from Baseline to end of treatment
The EREFS score (Eosinophilic esophagitis endoscopic reference score) is a classification and grading system for the endoscopic assessment of the esophageal features of eosinophilic esophagitis. The grading is used either to assess the severity of endoscopic findings from 0=´none´ to 2 or 3=´severe´ or to classify 0=´absent´ or 1=´present´.The total score will be calculated and compared between Baseline and end of treatment. A higher score correlates with more severe eosinophilic esophagitis symptoms.
Measured: From Baseline (Visit 2) to end of treatment (Visit 5 = 4-7 weeks after Visit 2)
Incidence of treatment-emergent Adverse Events
All Adverse Events occurring from the first investigational medicinal product administration onwards are defined as treatment-emergent Adverse Events.
Measured: Visit 3 (Day 0) to day 42
Incidence of treatment-emergent Serious Adverse Events
All Serious Adverse Events occurring from the first investigational medicinal product administration onwards are defined as treatment-emergent Serious Adverse Events.
Measured: Visit 3 (Day 0) to day 42
Incidence of AESI
The following AEs are defined as AEs of special interest (AESI), if these events were not already present at Visit 2:
- Oral candidiasis;
- Oropharyngeal candidiasis.
Measured: Visit 2 (day -21 to -1) to Visit 6 (day 42)
Local tolerability
The local tolerability of the IMP administration will be evaluated daily throughout the treatment period in the patient diary. Patients should indicate whether they had any discomfort in mouth, throat or esophagus while taking IMP on a VAS (Visual analog scale) ranging from 'no discomfort' to 'the worst imaginable discomfort'. The first assessment on Day 0 recorded in the patient diary after IMP intake will be considered Baseline.
Measured: From Baseline (Visit 3) to end of treatment (Visit 5 = 28 days after Visit 3)
Patient-reported treatment satisfaction at end of treatment based on questions about handling, taste, and time necessary for administration
Patients will be asked to answer a questionnaire about their satisfaction with the IMP treatment at Visit 5. Questions will cover the general satisfaction with the IMP, the swallowability of the IMP, and the frequency of administration. Answers involve gradings from 0 (the best outcome) to 3 or 4 (the worst outcome) plus an indication for the preference of single or multiple administrations of the investigated product.
Measured: At end of treatment (Visit 5 = day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start29 Jun 2021
- Primary completion9 Oct 2023
- Study completion9 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- EsoCap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH, FGK Representative Service B.V.
- Responsible party
- Sponsor
- Investigators
- Isabelle Racamier, Study director, EsoCap AG (Malzgasse 9, 4052 Basel, Switzerland)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04849390
- Sponsor's protocol ID
- ACESO
- Other IDs
- 2020-000082-16
- Status last verified
- Nov 2023
- First submitted
- 2 Apr 2021
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lucendo AJ, Nantes-Castillejo O, Straumann A, Biedermann L, Bredenoord AJ, Guagnozzi D, Blas-Jhon L, Wiechowska-Kozlowska A, Weidlich S, von Arnim U, Santander-Vaquero C, Perello A, Perez-Martinez I, Barrio J, Vieth M, Gouya G, Dellon ES. Clinical Trial: Safety and Efficacy of a Novel Oesophageal Delivery System for Topical Corticosteroids Versus Placebo in the Treatment of Eosinophilic Oesophagitis. Aliment Pharmacol Ther. 2025 Feb;61(3):444-455. doi: 10.1111/apt.18443. Epub 2024 Dec 16.
PubMed 39676687
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blind Trial Evaluating the Efficacy, Tolerability and Safety of ESO-101 in Adult Patients With Active Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT04849390
- Acronym / sponsor ID
- ACESO
- Conditions
- Eosinophilic Esophagitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- EsoCap AGIndustry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH, FGK Representative Service B.V.
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 9 Oct 2023 (actual)
- Study completion
- 9 Oct 2023 (actual)
- First posted
- 19 Apr 2021 (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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESO-101 | Experimental | Drug: ESO-101Oral use of 1 hard gelatin capsule (800 μg) |
| Placebo | Placebo comparator | Drug: PlaceboOral use of 1 hard gelatin capsule |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Adult patients aged 18-70 years;
- Confirmed clinicopathological diagnosis of EoE (eosinophilic esophagitis);
- Active and symptomatic EoE, defined as:
- Written informed consent;
- Willingness and ability to comply with the protocol for the duration of the trial;
Key exclusion criteria (28 listed)
- Women who are pregnant, lactating, possibly pregnant or planning a pregnancy during the trial period;
- Current or past (within the last 3 months) alcohol or drug abuse;
- Initiation of a diet-modifying food restriction within 4 weeks before the screening endoscopy (Visit 2) until EOT (end of treatment);
- Use of systemic corticosteroids or biologic immunomodulators within 3 months before the screening endoscopy (Visit 2) until the EOT;
- 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;
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 |
|---|---|---|
| ESO-101Also: Mometasone furoate (800 μg)Daily administration in the evening at bedtime for 28 days | Drug | ESO-101 |
| PlaceboDaily administration in the evening at bedtime for 28 days | Drug | Placebo |
Primary outcome
Absolute change in peak eosinophil count from Baseline to end of treatment
Time frame: From Baseline (Visit 2) to end of treatment (Visit 5 = 4-7 weeks after Visit 2)
The processing and analysis of biopsy samples taken at Visit 2 and end of treatment (Visit 5) will be performed blinded at a central laboratory according to a laboratory manual. At both visits, 6 biopsy samples will be taken, 2 each from the proximal, mid, and distal segment of the esophagus. Histology results of the biopsies at Visit 2 will be considered baseline values. For the peak number of eosinophils, hematoxylin and eosin stained esophageal biopsy specimen will be assessed and the high-powered fields with the highest density of eosinophils will be counted.
18 secondary outcomes
Proportion of patients with histological remission, defined as the reduction of peak eosinophil count in all esophageal samples to <15 eosinophils/hpf at end of treatment, overall and determined differentially in each of the 3 esophageal segments
Time frame: From Baseline (Visit 2) to end of treatment (Visit 5 = 4-7 weeks after Visit 2)
Proportion of patients with a peak eosinophil count in all esophageal samples of <6 eosinophils/hpf at end of treatment, overall and determined differentially in each of the 3 esophageal segments
Time frame: End of treatment (Visit 5 = day 28)
Proportion of patients with an improvement in the dysphagia severity score from Baseline to end of treatment
Time frame: From Baseline (Visit 3) to end of treatment (Visit 5 = 28 days after Visit 3)
Absolute change in mean eosinophil count from Baseline to end of treatment
Time frame: From Baseline (Visit 2) to end of treatment (Visit 5 = 4-7 weeks after Visit 2)
Relative change in mean eosinophil count from Baseline to end of treatment
Time frame: From Baseline (Visit 2) to end of treatment (Visit 5 = 4-7 weeks after Visit 2)
Proportion of patients with a relative reduction in peak eosinophil count of ≥30 percent from Baseline to end of treatment
Time frame: From Baseline (Visit 2) to end of treatment (Visit 5 = 4-7 weeks after Visit 2)
Proportion of patients with a relative reduction in peak eosinophil count of ≥50 percent from Baseline to end of treatment
Time frame: From Baseline (Visit 2) to end of treatment (Visit 5 = 4-7 weeks after Visit 2)
Proportion of patients with a relative reduction in peak eosinophil count of ≥75 percent from Baseline to end of treatment
Time frame: From Baseline (Visit 2) to end of treatment (Visit 5 = 4-7 weeks after Visit 2)
Proportion of patients with histological remission AND improvement in the dysphagia severity score from Baseline to end of treatment
Time frame: From Baseline (Visit 2 + 3) to end of treatment (Visit 5 = 4-7 weeks after Visit 2)
Absolute change in dysphagia and odynophagia severity scores from Baseline
Time frame: From Baseline (Visit 3) to end of treatment (Visit 5 = 28 days after Visit 3)
Relative change in dysphagia and odynophagia severity scores from Baseline
Time frame: From Baseline (Visit 3) to end of treatment (Visit 5 = 28 days after Visit 3)
Time to achieve symptom relief (defined as 50 percent improvement in the dysphagia or odynophagia symptoms on an NRS compared to Baseline)
Time frame: From Baseline (Visit 3) to end of treatment (Visit 5 = 28 days after Visit 3)
Change in the EREFS from Baseline to end of treatment
Time frame: From Baseline (Visit 2) to end of treatment (Visit 5 = 4-7 weeks after Visit 2)
Incidence of treatment-emergent Adverse Events
Time frame: Visit 3 (Day 0) to day 42
Incidence of treatment-emergent Serious Adverse Events
Time frame: Visit 3 (Day 0) to day 42
Incidence of AESI
Time frame: Visit 2 (day -21 to -1) to Visit 6 (day 42)
Local tolerability
Time frame: From Baseline (Visit 3) to end of treatment (Visit 5 = 28 days after Visit 3)
Patient-reported treatment satisfaction at end of treatment based on questions about handling, taste, and time necessary for administration
Time frame: At end of treatment (Visit 5 = day 28)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Derived from this study: PubMed 39676687Lucendo AJ, Nantes-Castillejo O, Straumann A, Biedermann L, Bredenoord AJ, Guagnozzi D, Blas-Jhon L, Wiechowska-Kozlowska A, Weidlich S, von Arnim U, Santander-Vaquero C, Perello A, Perez-Martinez I, Barrio J, Vieth M, Gouya G, Dellon ES. Clinical Trial: Safety and Efficacy of a Novel Oesophageal Delivery System for Topical Corticosteroids Versus Placebo in the Treatment of Eosinophilic Oesophagitis. Aliment Pharmacol Ther. 2025 Feb;61(3):444-455. doi: 10.1111/apt.18443. Epub 2024 Dec 16.
- 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.
Isabelle Racamier study director
EsoCap AG (Malzgasse 9, 4052 Basel, Switzerland)
17 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ESO-101 in people with Eosinophilic Esophagitis, run by EsoCap AG at 17 sites in 5 countries.
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 15 inclusion and 28 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: finished, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Spain, Germany, Netherlands, Poland, Switzerland. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Absolute change in peak eosinophil count from Baseline to end of treatment (time frame: From Baseline (Visit 2) to end of treatment (Visit 5 = 4-7 weeks after Visit 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04849390, which also lists 1 linked publication.
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 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.