Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT05608681
Ethics application status
Date submitted
19/10/2022
Date registered
8/11/2022
Date last updated
30/07/2024

Titles & IDs
Public title
A Trial to Evaluate EP-104IAR in Adults With Eosinophilic Esophagitis (EoE).
Scientific title
A Phase 1b/2a, Open Label Trial Evaluating the Safety, Pharmacokinetics, and Efficacy of EP-104IAR in Adults With Eosinophilic Esophagitis (RESOLVE)
Secondary ID [1] 0 0
EP-104IAR-102 (RESOLVE)
Universal Trial Number (UTN)
Trial acronym
RESOLVE
Linked study record

Health condition
Health condition(s) or problem(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
Other inflammatory or immune system disorders
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - EP-104IAR

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

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

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

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

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

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

Experimental: EP-104IAR 72 mg - 12 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.

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

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


Treatment: Drugs: EP-104IAR
Long-acting fluticasone propionate for injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of treatment emergent adverse events (TEAEs)
Timepoint [1] 0 0
52 weeks
Primary outcome [2] 0 0
Severity of treatment emergent adverse events (TEAEs)
Timepoint [2] 0 0
52 weeks
Primary outcome [3] 0 0
Change from baseline in morning serum cortisol levels
Timepoint [3] 0 0
52 weeks
Primary outcome [4] 0 0
Plasma concentrations of fluticasone propionate
Timepoint [4] 0 0
52 weeks
Primary outcome [5] 0 0
Change from baseline in clinical safety laboratory measurements
Timepoint [5] 0 0
12 weeks
Primary outcome [6] 0 0
Change from baseline in vital signs and physical examination results
Timepoint [6] 0 0
12 weeks
Secondary outcome [1] 0 0
Peak eosinophil count (PEC)
Timepoint [1] 0 0
4 weeks
Secondary outcome [2] 0 0
Peak eosinophil count (PEC)
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
Peak eosinophil count (PEC)
Timepoint [3] 0 0
36 weeks
Secondary outcome [4] 0 0
Change from baseline in the Straumann Dysphagia Index (SDI) score
Timepoint [4] 0 0
2 weeks
Secondary outcome [5] 0 0
Change from baseline in the Straumann Dysphagia Index (SDI) score
Timepoint [5] 0 0
4 weeks
Secondary outcome [6] 0 0
Change from baseline in the Straumann Dysphagia Index (SDI) score
Timepoint [6] 0 0
8 weeks
Secondary outcome [7] 0 0
Change from baseline in the Straumann Dysphagia Index (SDI) score
Timepoint [7] 0 0
12 weeks
Secondary outcome [8] 0 0
Change from baseline in the Straumann Dysphagia Index (SDI) score
Timepoint [8] 0 0
24 weeks
Secondary outcome [9] 0 0
Change from baseline in the Straumann Dysphagia Index (SDI) score
Timepoint [9] 0 0
36 weeks
Secondary outcome [10] 0 0
Change from baseline in the Straumann Dysphagia Index (SDI) score
Timepoint [10] 0 0
52 weeks
Secondary outcome [11] 0 0
Change from baseline in dysphagia measured on an 11 point Likert scale
Timepoint [11] 0 0
4 weeks
Secondary outcome [12] 0 0
Change from baseline in dysphagia measured on an 11 point Likert scale
Timepoint [12] 0 0
8 weeks
Secondary outcome [13] 0 0
Change from baseline in dysphagia measured on an 11 point Likert scale
Timepoint [13] 0 0
12 weeks
Secondary outcome [14] 0 0
Change from baseline in dysphagia measured on an 11 point Likert scale
Timepoint [14] 0 0
24 weeks
Secondary outcome [15] 0 0
Change from baseline in dysphagia measured on an 11 point Likert scale
Timepoint [15] 0 0
36 weeks
Secondary outcome [16] 0 0
Change from baseline in dysphagia measured on an 11 point Likert scale
Timepoint [16] 0 0
52 weeks
Secondary outcome [17] 0 0
Change from baseline in odynophagia measured on an 11 point Likert scale
Timepoint [17] 0 0
4 weeks
Secondary outcome [18] 0 0
Change from baseline in odynophagia measured on an 11 point Likert scale
Timepoint [18] 0 0
8 weeks
Secondary outcome [19] 0 0
Change from baseline in odynophagia measured on an 11 point Likert scale
Timepoint [19] 0 0
12 weeks
Secondary outcome [20] 0 0
Change from baseline in odynophagia measured on an 11 point Likert scale
Timepoint [20] 0 0
24 weeks
Secondary outcome [21] 0 0
Change from baseline in odynophagia measured on an 11 point Likert scale
Timepoint [21] 0 0
36 weeks
Secondary outcome [22] 0 0
Change from baseline in odynophagia measured on an 11 point Likert scale
Timepoint [22] 0 0
52 weeks
Secondary outcome [23] 0 0
Change from baseline in the EoE Endoscopic Reference Score (EREFS)
Timepoint [23] 0 0
4 weeks
Secondary outcome [24] 0 0
Change from baseline in the EoE Endoscopic Reference Score (EREFS)
Timepoint [24] 0 0
12 weeks
Secondary outcome [25] 0 0
Change from baseline in the EoE Endoscopic Reference Score (EREFS)
Timepoint [25] 0 0
36 weeks
Secondary outcome [26] 0 0
Change from baseline in EoE Histology Scoring System (EoEHSS) score
Timepoint [26] 0 0
4 weeks
Secondary outcome [27] 0 0
Change from baseline in EoE Histology Scoring System (EoEHSS) score
Timepoint [27] 0 0
12 weeks
Secondary outcome [28] 0 0
Change from baseline in EoE Histology Scoring System (EoEHSS) score
Timepoint [28] 0 0
36 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
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;
* 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
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
1/12/2025
Actual
Sample size
Target
57
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
British Columbia
Country [2] 0 0
Canada
State/province [2] 0 0
Quebec
Country [3] 0 0
Netherlands
State/province [3] 0 0
Amsterdam

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

Ethics approval
Ethics application status

Summary
Brief summary
An open-label, dose-escalation study to explore the safety, tolerability and pharmacokinetics of EP-104IAR in adults with eosinophilic esophagitis (EoE). Endoscopic and histologic assessments will also be evaluated to understand the local effects of EP-104IAR on eosinophilic EoE disease activity.

Approximately 27 to 33 participants will be enrolled in dose escalation: 3-6 participants per dose cohort in approximately 9 cohorts. The number of participants enrolled in escalation will depend on the number of dose escalation cohorts evaluated, and dose cohorts needing to be expanded.

An additional 10-24 participants will be enrolled in 1 or 2 cohorts of 10-12 participants each at tolerable dose regimen(s) selected based on the accumulated clinical data to identify the recommended phase 2 dose(s) (RP2D).

The study involves 8-10 site visits spread over approximately 24-52 weeks.

All participants will receive active study drug (EP-104IAR), The study drug will be administered by qualified personnel during an esophagogastroduodenoscopy (EGD) procedure at the Baseline/Dosing visit.

Safety will be assessed throughout the study. Blood and urine samples will be collected at site visits for laboratory assessments and to measure plasma levels of EP-104IAR.

Participants will complete questionnaires to assess symptoms of dysphagia and odynophagia and will undergo 3-4 EGDs with esophageal biopsies at the Baseline/Dosing Visit, at 4, 12 and 36 weeks post dose.
Trial website
https://clinicaltrials.gov/study/NCT05608681
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Amanda Malone, 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
Christine Dobek, MSc
Address 0 0
Country 0 0
Phone 0 0
778-873-8939
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05608681