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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05608681




Registration number
Help: Registration number
NCT05608681
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
19/10/2022
Date registered
Help: Date registered
8/11/2022
Date last updated
Help: Date last updated
19/03/2026

Titles & IDs
Public title
A Trial to Evaluate EP-104GI in Adults With Eosinophilic Esophagitis (EoE).
Scientific title
A Phase 1b/2 Trial Evaluating the Safety, Pharmacokinetics, and Efficacy of EP-104GI in Adults With Eosinophilic Esophagitis (RESOLVE)
Additional trial identifiers [1] 0 0
EP-104IAR-102 (RESOLVE)
Universal Trial Number (UTN)
Trial acronym
RESOLVE
Related trial records

Health condition
Health condition(s) studied:
Eosinophilic Esophagitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Allergies
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Treatment: Drugs - EP-104GI
Other interventions - Matching vehicle control

Experimental: EP-104GI 4 mg - 4 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.

Experimental: EP-104GI 8 mg - 8 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.

Experimental: EP-104GI 20 mg - 8 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.

Experimental: EP-104GI 30 mg - 12 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.

Experimental: EP-104GI 48 mg - 12 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.

Experimental: EP-104GI 64 mg - 16 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.

Experimental: EP-104GI 80 mg - 20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.

Experimental: EP-104GI 96 mg - 16 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.

Experimental: EP-104GI 120 mg - 20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.

Placebo comparator: EP-104GI Dose A or matching vehicle control - 20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.

Experimental: EP-104GI 160 mg - 20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.

Placebo comparator: EP-104GI Dose B or matching vehicle control - 20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.


Treatment: Drugs: EP-104GI
Extended-release fluticasone propionate \[FP\] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle

Other interventions: Matching vehicle control
A sterile liquid containing sterile water and excipients necessary to prepare a uniform suspension of the powder.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Description of the comparator or control
Control group

Outcomes
Primary outcome [1] 0 0
Dose Escalation- Incidence of treatment emergent adverse events (TEAEs)
Timepoint [1] 0 0
52 weeks
Primary outcome [2] 0 0
Dose Escalation- Severity of treatment emergent adverse events (TEAEs)
Timepoint [2] 0 0
52 weeks
Primary outcome [3] 0 0
Dose Escalation- Change from baseline in morning serum cortisol levels
Timepoint [3] 0 0
52 weeks
Primary outcome [4] 0 0
Dose Escalation- Plasma concentrations of fluticasone propionate
Timepoint [4] 0 0
108 weeks
Primary outcome [5] 0 0
Dose Escalation- Change from baseline in physical examination results, BMI and weight change.
Timepoint [5] 0 0
12 weeks
Primary outcome [6] 0 0
Randomised Dose Optimization- Change from baseline in EoEHSS grade and stage scored in 3 regions of the esophagus within the injection area (proximal, mid, distal)
Timepoint [6] 0 0
24 weeks
Secondary outcome [1] 0 0
Dose Escalation- Peak eosinophil count (PEC)
Timepoint [1] 0 0
36 weeks
Secondary outcome [2] 0 0
Dose Escalation- Change from baseline in the Straumann Dysphagia Index (SDI) score
Timepoint [2] 0 0
52 weeks
Secondary outcome [3] 0 0
Dose Escalation- Change from baseline in dysphagia measured on an 11 point Likert scale
Timepoint [3] 0 0
52 weeks
Secondary outcome [4] 0 0
Dose Escalation- Change from baseline in the EoE Endoscopic Reference Score (EREFS)
Timepoint [4] 0 0
36 weeks
Secondary outcome [5] 0 0
Dose Escalation- Change from baseline in odynophagia measured on an 11 point Likert scale
Timepoint [5] 0 0
52 weeks
Secondary outcome [6] 0 0
Dose Escalation- Change from baseline in EoE Histology Scoring System (EoEHSS) score
Timepoint [6] 0 0
36 weeks
Secondary outcome [7] 0 0
Randomised Dose Optimization- Change from baseline in the Straumann Dysphagia Index (SDI) score
Timepoint [7] 0 0
52 weeks
Secondary outcome [8] 0 0
Randomised Dose Optimization- Change from baseline in the Dysphagia symptom questionnaire (DSQ) v4.0 and "Dysphagia days"
Timepoint [8] 0 0
52 weeks
Secondary outcome [9] 0 0
Randomised Dose Optimization- Change from baseline in the Eosinophilic Esophagitis Impact Questionnaire (EoE IQ)
Timepoint [9] 0 0
52 weeks
Secondary outcome [10] 0 0
Randomised Dose Optimization- Change from baseline in the Patient Global Impression of Change (PGIC)
Timepoint [10] 0 0
52 weeks
Secondary outcome [11] 0 0
Randomised Dose Optimization- Change from baseline in the Patient Global Impression of Severity (PGIS)
Timepoint [11] 0 0
52 weeks
Secondary outcome [12] 0 0
Randomised Dose Optimization- Change from baseline in peak eosinophil count (PEC)
Timepoint [12] 0 0
52 weeks
Secondary outcome [13] 0 0
Randomised Dose Optimization- Change from baseline in the EoE Endoscopic Reference Score (EREFS) in 3 regions of the esophagus within the injection area (proximal, mid, distal)
Timepoint [13] 0 0
52 weeks
Secondary outcome [14] 0 0
Randomised Dose Optimization- Change in endoscopist's global impression of severity
Timepoint [14] 0 0
52 weeks
Secondary outcome [15] 0 0
Randomised Dose Optimization- Change from baseline in EoE Histology Scoring System (EoEHSS) score in 3 regions of the esophagus within the injection area (proximal, mid, distal), excluding Week 24 as this is the primary endpoint
Timepoint [15] 0 0
52 weeks
Secondary outcome [16] 0 0
Randomised Dose Optimization- Change from baseline in morning serum cortisol levels
Timepoint [16] 0 0
52 weeks
Secondary outcome [17] 0 0
Randomised Dose Optimization- Change from baseline in vital signs (temperature, blood pressure, pulse, and respiratory rate) results
Timepoint [17] 0 0
52 weeks
Secondary outcome [18] 0 0
Randomised Dose Optimization- Change from baseline in physical examination results, BMI and weight change.
Timepoint [18] 0 0
52 weeks
Secondary outcome [19] 0 0
Randomised Dose Optimization- Plasma concentrations of fluticasone propionate
Timepoint [19] 0 0
108 weeks

Eligibility
Key inclusion criteria
* Symptomatic EoE;
* For women of childbearing potential, a negative pregnancy test and willing to use a highly effective method of birth control until end of study;
* Willing and able to adhere to study-related procedures and visit schedule;
* Willing and able to provide informed consent.

Criteria for crossover to EP 104GI from vehicle control (randomized dose optimization portion):

1. Has completed the randomized dose optimization portion of the trial to Week 24, inclusive
2. Without safety concerns for receiving EP 104GI ie, does not meet exclusion criteria or have other safety issue
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
* Concomitant esophageal disease, relevant GI disease, or any condition, history, or laboratory abnormality that might interfere with the study;
* Oral or esophageal mucosal infection of any type (bacterial, viral, or fungal);
* Oropharyngeal or dental conditions that prevents normal eating;
* Severe esophageal motility disorders other than EoE;
* Contraindication to or factors that substantially increase risks associated with EGD or biopsy, or narrowing of the esophagus that precludes EGD with a standard 9-10 mm endoscope, stricture requiring dilation within 8 weeks prior to Screening, or the need for dilation prior to EGD at Baseline;
* Any condition for which the use of corticosteroids is contraindicated (Participants with well controlled non-insulin dependent diabetes are permitted);
* Active or quiescent systemic fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex. Or recent use of IV or oral antibiotics;
* Hypersensitivity, or intolerance to corticosteroids, or to any of the ingredients in the investigational medicinal product, including carboxymethyl cellulose, and polysorbate 80, or to the ingredients in Synacthen / cosyntropin (used in the ACTH stimulation test);
* Recent use of disallowed medications, or unwillingness to not use disallowed medications during the study;
* Recent initiation of a elimination or elemental diet (dietary therapy must remain stable throughout the study);
* Morning serum cortisol level = 5 µg/dL (138 nmol/L);
* Clinically significant abnormal laboratory values;
* Recent or currently planned participation in another interventional trial ;
* Previous participation in this study and had received study treatment;
* Females who are pregnant, breastfeeding, or planning to become pregnant during the study;
* Malignancies or history of malignancy within prior 5 years, except for treated or excised non-metastatic BCC, SCC of the skin, or cervical carcinoma in situ;
* History of alcohol or drug abuse;
* Any other reason, that, in the Investigator's opinion, unfavorably alters participant risk, confounds results, or prevents the participant from complying with study requirements.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
117
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Campbelltown Private Hospital - Sydney
Recruitment hospital [2] 0 0
Mater Hospital Brisbane - Brisbane
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [4] 0 0
Coastal Digestive Health - Maroochydore
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 0 0
Eastern Health Box Hill - Box Hill
Recruitment hospital [7] 0 0
Northern Hospital Epping - Epping
Recruitment hospital [8] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [9] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Maroochydore
Recruitment postcode(s) [4] 0 0
- Adelaide
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
- Epping
Recruitment postcode(s) [7] 0 0
- Melbourne
Recruitment postcode(s) [8] 0 0
- Parkville
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Quebec
Country [4] 0 0
Netherlands
State/province [4] 0 0
Amsterdam
Country [5] 0 0
Netherlands
State/province [5] 0 0
Holland
Country [6] 0 0
New Zealand
State/province [6] 0 0
Auckland
Country [7] 0 0
New Zealand
State/province [7] 0 0
Hamilton
Country [8] 0 0
New Zealand
State/province [8] 0 0
Lower Hutt
Country [9] 0 0
Switzerland
State/province [9] 0 0
Zurich
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Norfolk
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Cardiff
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Liverpool
Country [13] 0 0
United Kingdom
State/province [13] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eupraxia Pharmaceuticals Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mark Kowalski, MD PhD
Address 0 0
Eupraxia Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Pranali Ravikumar, MS
Address 0 0
Country 0 0
Phone 0 0
647-895-3016
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05608681