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Clinical Trial NCT05608681 (RESOLVE) for Eosinophilic Esophagitis is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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A Trial to Evaluate EP-104GI in Adults With Eosinophilic Esophagitis (EoE). (RESOLVE) Phase 1, Phase 2 117 Randomized Crossover Design Dose Escalation
Clinical Trial NCT05608681 (RESOLVE) is designed to study Treatment for Eosinophilic Esophagitis. It is a Phase 1 Phase 2 interventional study that is recruiting, having started on 31 March 2023, with plans to enroll 117 participants. Led by Eupraxia Pharmaceuticals Inc., it is expected to complete by 1 December 2026. The latest data from ClinicalTrials.gov was last updated on 19 March 2026.
Brief Summary
A Phase 1b/2 study to explore the safety, efficacy and pharmacokinetics of EP-104GI in adults with eosinophilic esophagitis (EoE). Endoscopic and histologic assessments will also be evaluated to understand the local effects of EP-104GI on eosinophilic EoE disease activity. Approximately 27 to 33 participants will be enrolled in dose escalation: 3-6 participants per dose cohort. The number of participants enrolled in ...Show More
Official Title
A Phase 1b/2 Trial Evaluating the Safety, Pharmacokinetics, and Efficacy of EP-104GI in Adults With Eosinophilic Esophagitis (RESOLVE)
Conditions
Eosinophilic EsophagitisOther Study IDs
- RESOLVE
- EP-104IAR-102 (RESOLVE)
NCT ID Number
Start Date (Actual)
2023-03-31
Last Update Posted
2026-03-19
Completion Date (Estimated)
2026-12
Enrollment (Estimated)
117
Study Type
Interventional
PHASE
Phase 1
Phase 2
Phase 2
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
Quadruple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalEP-104GI 4 mg 4 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. | EP-104GI Extended-release fluticasone propionate \[FP\] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle |
ExperimentalEP-104GI 8 mg 8 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. | EP-104GI Extended-release fluticasone propionate \[FP\] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle |
ExperimentalEP-104GI 20 mg 8 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. | EP-104GI Extended-release fluticasone propionate \[FP\] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle |
ExperimentalEP-104GI 30 mg 12 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. | EP-104GI Extended-release fluticasone propionate \[FP\] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle |
ExperimentalEP-104GI 48 mg 12 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. | EP-104GI Extended-release fluticasone propionate \[FP\] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle |
ExperimentalEP-104GI 64 mg 16 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. | EP-104GI Extended-release fluticasone propionate \[FP\] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle |
ExperimentalEP-104GI 80 mg 20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. | EP-104GI Extended-release fluticasone propionate \[FP\] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle |
ExperimentalEP-104GI 96 mg 16 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. | EP-104GI Extended-release fluticasone propionate \[FP\] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle |
ExperimentalEP-104GI 120 mg 20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. | EP-104GI Extended-release fluticasone propionate \[FP\] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle |
Placebo ComparatorEP-104GI Dose A or matching vehicle control 20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. | EP-104GI Extended-release fluticasone propionate \[FP\] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle Matching vehicle control A sterile liquid containing sterile water and excipients necessary to prepare a uniform suspension of the powder. |
ExperimentalEP-104GI 160 mg 20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. | EP-104GI Extended-release fluticasone propionate \[FP\] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle |
Placebo ComparatorEP-104GI Dose B or matching vehicle control 20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. | EP-104GI Extended-release fluticasone propionate \[FP\] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle Matching vehicle control A sterile liquid containing sterile water and excipients necessary to prepare a uniform suspension of the powder. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Dose Escalation- Incidence of treatment emergent adverse events (TEAEs) | TEAEs will be summarized by dose/cohort | 52 weeks |
Dose Escalation- Severity of treatment emergent adverse events (TEAEs) | TEAEs will be summarized by dose/cohort and severity (mild, moderate, severe). | 52 weeks |
Dose Escalation- Change from baseline in morning serum cortisol levels | Cortisol will be will be summarized by dose/cohort and over time and compared to pre-dose values. A prolonged and clinically significant reduction in cortisol may indicate adrenal insufficiency. | 52 weeks |
Dose Escalation- Plasma concentrations of fluticasone propionate | Plasma concentrations of fluticasone propionate over time will be used to calculate PK parameters for each dose/cohort. | 108 weeks |
Dose Escalation- Change from baseline in physical examination results, BMI and weight change. | Physical examination results, BMI and weight will be summarized by dose/cohort and over time and compared to pre-dose values. | 12 weeks |
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) | The EoEHSS scores the stage and grade of 8 histologic items: eosinophil inflammation, basal zone hyperplasia, dilated intercellular spaces, eosinophil abscesses, surface layering, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis), on separate 4-point Likert scales. A composite EoEHSS grade and stage scores are calculated by summing the individual grade and stage items and dividing by the maximum score for evaluated items (range, 0-1). A lower score indicates improvement. | 24 weeks |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Dose Escalation- Peak eosinophil count (PEC) | Biopsy specimens will be used to evaluate peak eosinophil counts (PEC). A higher number of eosinophils indicates more severe histological disease. | 36 weeks |
Dose Escalation- Change from baseline in the Straumann Dysphagia Index (SDI) score | The SDI is a patient-reported outcome measure of dysphagia with a 7-day recall period. The SDI assesses the frequency and intensity of dysphagia on two separate 5-point and 6-point scales. Total SDI scores are calculated by adding the two sub-scores (range, 0-9), with a higher total score indicating more severe dysphagia. | 52 weeks |
Dose Escalation- Change from baseline in dysphagia measured on an 11 point Likert scale | The participant will assess the severity of their dysphagia symptoms (troubles to swallow) over the previous 7-days using an 11-point Likert scale where 0 = no trouble and 10 = most severe trouble swallowing. | 52 weeks |
Dose Escalation- Change from baseline in the EoE Endoscopic Reference Score (EREFS) | Endoscopic Reference Score (EREFS) scoring system is used to determine the severity of 5 endoscopic findings: edema, rings, exudates, furrows, and strictures. The total EREFS is calculated by summing the grades of the 5 individual endoscopic items (range, 0 to 9), with higher scores indicating more severe endoscopic disease. | 36 weeks |
Dose Escalation- Change from baseline in odynophagia measured on an 11 point Likert scale | The participant will assess the severity of their pain during swallowing over the previous 7 days using an 11 point Likert scale where 0 = no pain and 10 = most severe pain during swallowing. | 52 weeks |
Dose Escalation- Change from baseline in EoE Histology Scoring System (EoEHSS) score | The EoEHSS scores the stage and grade of 8 histologic items: eosinophil inflammation, basal zone hyperplasia, dilated intercellular spaces, eosinophil abscesses, surface layering, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis), on separate 4-point Likert scales. A composite EoEHSS grade and stage scores are calculated by summing the individual grade and stage items and dividing by the maximum score for evaluated items (range, 0-1). A lower score indicates improvement. | 36 weeks |
Randomised Dose Optimization- Change from baseline in the Straumann Dysphagia Index (SDI) score | The SDI is a patient-reported outcome measure of dysphagia with a 7-day recall period. The SDI assesses the frequency and intensity of dysphagia on two separate 5-point and 6-point scales. Total SDI scores are calculated by adding the two sub-scores (range, 0-9), with a higher total score indicating more severe dysphagia. | 52 weeks |
Randomised Dose Optimization- Change from baseline in the Dysphagia symptom questionnaire (DSQ) v4.0 and "Dysphagia days" | The DSQ is assessed daily over a period of 14 days and comprises four questions; one question on whether the participant has eaten solid food and three questions on the presence and severity of EoE dysphagia."Dysphagia Days" is defined as the number of days with a yes answer to the following question: During any meal today, did food go down slowly or get stuck in your throat or chest? | 52 weeks |
Randomised Dose Optimization- Change from baseline in the Eosinophilic Esophagitis Impact Questionnaire (EoE IQ) | The EoE-IQ is a validated PRO instrument consisting of 11 questions assessing the impact of EoE on health related quality of life. | 52 weeks |
Randomised Dose Optimization- Change from baseline in the Patient Global Impression of Change (PGIC) | The PGIC reflects a participant's belief about the efficacy of treatment on a 7 point scale rating on a 4 point scale. | 52 weeks |
Randomised Dose Optimization- Change from baseline in the Patient Global Impression of Severity (PGIS) | The PGIS reflects a participant's belief about the efficacy of treatment based on severity ranging from none to very severe. | 52 weeks |
Randomised Dose Optimization- Change from baseline in peak eosinophil count (PEC) | Biopsy specimens will be used to evaluate peak eosinophil counts (PEC). A higher number of eosinophils indicates more severe histological disease. | 52 weeks |
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) | Endoscopic Reference Score (EREFS) scoring system is used to determine the severity of 5 endoscopic findings: edema, rings, exudates, furrows, and strictures. The total EREFS is calculated by summing the grades of the 5 individual endoscopic items (range, 0 to 9), with higher scores indicating more severe endoscopic disease. | 52 weeks |
Randomised Dose Optimization- Change in endoscopist's global impression of severity | The PGIC reflects a participant's belief about the efficacy of treatment on a 7 point scale rating overall improvement; the PGIS reflects a participant's belief about the severity of their symptoms on a 4 point scale | 52 weeks |
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 | The EoEHSS scores the stage and grade of 8 histologic items: eosinophil inflammation, basal zone hyperplasia, dilated intercellular spaces, eosinophil abscesses, surface layering, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis), on separate 4-point Likert scales. A composite EoEHSS grade and stage scores are calculated by summing the individual grade and stage items and dividing by the maximum score for evaluated items (range, 0-1). A lower score indicates improvement. | 52 weeks |
Randomised Dose Optimization- Change from baseline in morning serum cortisol levels | Cortisol will be will be summarized by dose/cohort and over time and compared to pre-dose values. A prolonged and clinically significant reduction in cortisol may indicate adrenal insufficiency. | 52 weeks |
Randomised Dose Optimization- Change from baseline in vital signs (temperature, blood pressure, pulse, and respiratory rate) results | Vital signs (temperature, blood pressure, pulse, and respiratory rate) results will be summarized by dose/cohort and over time and compared to pre-dose values. | 52 weeks |
Randomised Dose Optimization- Change from baseline in physical examination results, BMI and weight change. | Physical examination results, BMI and weight will be summarized by dose/cohort and over time and compared to pre-dose values. | 52 weeks |
Randomised Dose Optimization- Plasma concentrations of fluticasone propionate | Plasma concentrations of fluticasone propionate over time will be used to calculate PK parameters for each dose/cohort. | 108 weeks |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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):
- Has completed the randomized dose optimization portion of the trial to Week 24, inclusive
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.
Eupraxia Pharmaceuticals Inc.Study Central Contact
Contact: Pranali Ravikumar, MS, 647-895-3016, [email protected]
23 Study Locations in 6 Countries
New South Wales
Campbelltown Private Hospital, Sydney, New South Wales, Australia
Rashmi Gamage, Contact, [email protected]
Vincent Ho, MD, Principal Investigator
Recruiting
Queensland
Mater Hospital Brisbane, Brisbane, Queensland, Australia
Sharyn Grossman, Contact, [email protected]
Yoon-Kyo An, Principal Investigator
Recruiting
Princess Alexandra Hospital, Brisbane, Queensland, Australia
Teressa Hansen, Contact, [email protected]
Gerald Holtmann, MD, Principal Investigator
Recruiting
Coastal Digestive Health, Maroochydore, Queensland, Australia
Charlotte Early, Contact, [email protected]
Hans Seltenreich, Principal Investigator
Recruiting
South Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Joshua Zobel, Contact, [email protected]
Nam Nguyen, MD, Principal Investigator
Recruiting
Victoria
Eastern Health Box Hill, Box Hill, Victoria, 3128, Australia
Emma Dimitri, Contact, [email protected]
Sanjay Nandurkar, MD, Principal Investigator
Recruiting
Northern Hospital Epping, Epping, Victoria, Australia
Gloria Sepe, Contact, [email protected]
Mayur Garg, Principal Investigator
Recruiting
The Alfred Hospital, Melbourne, Victoria, Australia
Jean Zhang, Contact, [email protected]
Rebecca Burgell, Principal Investigator
Recruiting
Royal Melbourne Hospital, Parkville, Victoria, Australia
Irene Bell, Contact, [email protected]
Nicholas Hannah, Principal Investigator
Recruiting
Alberta
University of Calgary, Calgary, Alberta, Canada
Contact, [email protected]
Milli Gupta, Principal Investigator
Recruiting
UoA - South Edmonton Gastroenterology Research Clinic, Edmonton, Alberta, Canada
Claire Graham, Contact, [email protected]
Jesse Siffledeen, Principal Investigator
Recruiting
British Columbia
G.I. Research Institute, Vancouver, British Columbia, V6Z 2K5, Canada
Maria Ancheta-Schmit, Contact, [email protected]
Hin Hin Ko, MD, Principal Investigator
Recruiting
Quebec
McGill University Health Center, Montreal, Quebec, Canada
Kim Azem, Contact, [email protected]
Waqqas Afif, MD, Principal Investigator
Recruiting
Amsterdam UMC, Amsterdam, 1105, Netherlands
Active, not recruiting
Erasmus University Medical Center, Holland, Netherlands
Milko van Langen, Contact, [email protected]
Peter Siersema, Principal Investigator
Recruiting
Auckland
Aotearoa Clinical Trials, Papatoetoe, Auckland, New Zealand
Indu Muniraj, Contact, [email protected]
Tien Huey Lim, Principal Investigator
Recruiting
Waikato Hospital, Hamilton, New Zealand
Heather Logan, Contact, [email protected]
Frank Weilert, Principal Investigator
Recruiting
Capital Coast and Hutt, Lower Hutt, New Zealand
Ana Enriquez, Contact, [email protected]
Stephen Inns, Principal Investigator
Recruiting
Universitätsspital Zürich, Zurich, Switzerland
Sabine Burk, Contact, [email protected]
Christopher Schlag, Principal Investigator
Recruiting
Norfolk
Norfolk and Norwich University Hospital, Norwich, Norfolk, United Kingdom
Sally Ann Copsey, Contact, [email protected]
Ian Beales, Principal Investigator
Recruiting
Cardiff and Vale University Health Board-Wales, Cardiff, United Kingdom
Maryanne Bray, Contact, [email protected]
Hasan N Haboubi, Principal Investigator
Recruiting
Royal Liverpool University Hospital, Liverpool, United Kingdom
CLAIRE BURSTON, Contact, [email protected]
Andrew Moore, Principal Investigator
Recruiting
St George's University of London, London, United Kingdom
Timtayo Oke, Contact, [email protected]
Jamal Hayat, Principal Investigator
Recruiting