A randomized, placebo-controlled, double-blind trial evaluating the efficacy, tolerability and safety of ESO-101 in adult patients with active eosinophilic esophagitis

Phase 2

Recruiting

• Conditions: chronic inflammation of the esophagus; eosinophilic esophagitis; 10017969

• Registration Number: NL-OMON52665
• Lead Sponsor: EsoCap AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1. Adult patients aged 18-70 years;
2. Confirmed clinicopathological diagnosis of EoE;
3. Active and symptomatic EoE, defined as:
a. 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;
b. 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:
a. combined (estrogen and progestogen containing) hormonal contraception
associated
with inhibition of ovulation (oral, intravaginal, transdermal);
b. progestogen-only hormonal contraception associated with inhibition of
ovulation
(oral, injectable, implantable);
c. intrauterine device or intrauterine hormone-releasing system;
d. bilateral tubal occlusion;
e. a vasectomized sexual partner;
f. 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;
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 (me

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate the efficacy based on the histological response:<br /><br>- absolute change in peak eosinophil count from Baseline to EOT</p><br>