| Trial ID: | L0438 |
| Source ID: | EUCTR2019-003876-38-GB
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| Associated Drug: |
EDP-305
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| Title: |
A Phase 2b Randomized, Double Blind, Placebo-Controlled, Multicenter Study Evaluating Safety and Efficacy of EDP-305 in Subjects with Liver-Biopsy Proven Non-Alcoholic Steatohepatitis (NASH) (ARGON-2) - ARGON-2
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| Acronym: |
--
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| Status: |
Authorised
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| Study Results: |
No Results Available
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| Results: |
--
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| Conditions: |
Non-alcoholic Steatohepatitis (NASH) <br>MedDRA version: 22.0
Level: LLT
Classification code 10029530
Term: Non-alcoholic fatty liver
System Organ Class: 100000004871
;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
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| Interventions: |
<br>Product Name: EDP-305<br>Product Code: EDP-305<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: Not available<br>CAS Number: 1933507-63-1<br>Current Sponsor code: EDP-305<br>Other descriptive name: EDP-305<br>Concentration unit: mg milligram(s)<
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| Outcome Measures: |
Main Objective: To evaluate the effect of EDP-305 compared to placebo on liver histology in non-cirrhotic NASH subjects with stage 2 or 3 fibrosis ;Secondary Objective: ?€? To evaluate the effect of EDP-305 on liver histology with assessments including:<br>- Improvement of fibrosis by at least 1 stage and/or resolution of NASH, without worsening of either <br>- No worsening of fibrosis and no worsening of NASH<br>- Resolution of fibrosis<br>- Improvement in each histological feature of NASH by at least 1 point <br>- Improvement of fibrosis by = 2 stages<br>- Improvement in non-alcoholic fatty liver disease activity score by at least 2 points with no worsening of fibrosis<br>- Histological progression to cirrhosis based on the overall assessment made<br>?€? To evaluate the safety of EDP-305 <br>?€? To evaluate the effect of EDP-305 on pruritus<br>?€? To evaluate the effect of EDP-305 on hepatic steatosis <br>?€? To evaluate the effect of EDP-305 on liver stiffness<br>?€? To evaluate the effect of EDP-305 on lipid profile<br>?€? To evaluate the pharmacokinetics of EDP-305 and its metabolites in plasma<br><br><br><br>;Primary end point(s): Proportion of subjects who achieve =1 stage improvement in fibrosis without worsening of steatohepatitis and/or resolution of steatohepatitis and no worsening of liver fibrosis as determined by liver biopsy at 72 weeks <br>;Timepoint(s) of evaluation of this end point: Week 72Timepoint(s) of evaluation of this end point: Week 72;Secondary end point(s): ?€? Proportion of subjects with improvement of fibrosis by at least 1 stage and/or resolution of NASH without worsening of either as determined by liver biopsy at Week 72<br>?€? Proportion of subjects with no worsening of fibrosis combined with no worsening of NASH as determined by liver biopsy at Week 72<br>?€? Proportion of subjects with resolution of fibrosis as determined by liver biopsy at Week 72<br>?€? Proportion of subjects with improvement in each histologic feature of NASH, by at least 1 point as determined by liver biopsy at Week 72<br>?€? Proportion of subjects with improvement of fibrosis by = 2 stages by liver biopsy at Week 72<br>?€? Proportion of subjects with improvement in NAS by at least 2 points with no worsening of fibrosis as determined by liver biopsy at Week 72<br>?€? Proportion of subjects with improvement of fibrosis and resolution of NASH as a composite endpoint as defined by both endpoints being met in the same subject<br>?€? Proportion of subjects with resolution of NASH and no worsening of liver fibrosis<br>?€? Proportion of subjects with histological progression to cirrhosis as determined by liver biopsy at Week 72<br>?€? Frequency of adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation through Week 72 and 4-week follow-up period <br>?€? Change from Baseline in 5D-itch scale and Visual Analog Score through Week 72<br>?€? Change from Baseline in percentage of fat in the liver as assessed by magnetic resonance imaging proton density fat fraction at Week 12 and Week 72<br>?€? Change from Baseline in liver stiffness as assessed by magnetic resonance elastography at Week 12 and Week 72<br>?€? Change from Baseline in triglycerides, total cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol and adiponectin through Week 72<br>?€? Pharmacokinetic concentrations of EDP-305 (and metabolites)<br><br>
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| Sponsor/Collaborators: |
Enanta Pharmaceuticals Inc.
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| Gender: |
All
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| Age: |
nannan
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| Phases: |
Phase 2
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| Enrollment: |
336
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| Study Type: |
Interventional clinical trial of medicinal product
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| Study Designs: |
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 3
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| Start Date: |
04/02/2020
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
13 July 2020
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| Locations: |
United States;France;Mexico;Canada;Argentina;Australia;Germany;United Kingdom;Korea, Republic of
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| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-003876-38
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