| Trial ID: | L0569 |
| Source ID: | EUCTR2016-001979-70-BE
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| Associated Drug: |
IVA337
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| Title: |
A randomized, double-blind, placebo-controlled, multicenter, dose-range, proof-of-concept, 24-week treatment study of IVA337 in adult subjects with nonalcoholic steatohepatitis (NASH)
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| Acronym: |
--
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| Status: |
Not Recruiting
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| Study Results: |
No Results Available
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| Results: |
--
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| Conditions: |
Nonalcoholic steatohepatitis (NASH) <br>MedDRA version: 20.1
Level: PT
Classification code 10053219
Term: Non-alcoholic steatohepatitis
System Organ Class: 10019805 - Hepatobiliary disorders
;Therapeutic area: Diseases [C] - Nutritional and Metabolic Dise
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| Interventions: |
<br>Product Name: Lanifibranor<br>Product Code: IVA337<br>Pharmaceutical Form: Film-coated tablet<br>INN or Proposed INN: Not Available<br>CAS Number: 927961-18-0<br>Current Sponsor code: IVA337<br>Other descriptive name: 1-(6-BENZOTHIAZOLYLSULFONYL)-5-CH
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| Outcome Measures: |
Main Objective: To assess the safety and the efficacy on the activity part of the Steatosis Activity Fibrosis histological score (inflammation and ballooning) of a 24-week treatment with two doses of Lanifibranor (800, 1200 mg/24h) in NASH adult patients.;Secondary Objective: Pharmacokinetics.;Primary end point(s): The primary endpoint is a binary outcome (responder / non responder). A responder is defined as a decrease from baseline to week 24 of at least 2 points of the SAF activity score combining hepatocellular inflammatory and ballooning score without fibrosis progression. Responder rates will be compared between the placebo and IMP groups at the end of the treatment period (week 24) using a Cochran Mantel Haenzel test stratified on diabetes.;Timepoint(s) of evaluation of this end point: At the end of the treatment period (week 24)Secondary end point(s): The following changes from baseline to 24 weeks of treatment will be evaluated:<br>?€?NASH improvers defined as subjects with a decrease of at least 2 points in NAS, and no worsening in fibrosis in NASH from baseline to end of treatment (week 24). <br>?€?Percent of patients with reversal of NASH (Steatosis without ballooning and with or without mild inflammation and no worsening of fibrosis) from baseline to end of treatment (week 24).<br>?€?Percent of patients with a change in components of SAF score from baseline to end of treatment (week 24):<br>-Steatosis: -1 point<br>-Lobular inflammation: -1 point<br>-Balloonning: -1 point<br>?€?Immunohistochemistry: change in the semiquantitative score of ballooning and stellate cell activation from baseline to end of treatment (week 24). <br>?€?Change in fibrosis score on a 4-point scale (SAF) and modified Ishak: - 1 point from baseline to end of treatment (week 24). Comparison of mean change in fibrosis area assessed by morphometry (CPA) from baseline to end of treatment (week 24).<br>?€?Liver enzymes (ALT, AST, ?GT) change from baseline to end of treatment (week 24).<br>?€?Inflammatory markers (fibrinogen, hs-CRP, alpha2 macroglobulin and haptoglobin levels) change from baseline to end of treatment (week 24).<br>?€?Glucose metabolism (fasting glucose and insulin, HOMA index and, in subjects with T2DM, HbA1c) change from baseline to end of treatment (week 24).<br>?€?Main plasma lipids levels (TC, HDL-C, calculated LDL-C, TG and apoA1) change from baseline to end of treatment (week 24).<br>?€?Adiponectin change from baseline to end of treatment (week 24).<br>;Timepoint(s) of evaluation of this end point: From baseline to 24 weeks of treatment
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| Sponsor/Collaborators: |
Inventiva S.A.
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| Gender: |
All
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| Age: |
nannan
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| Phases: |
Phase 2
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| Enrollment: |
225
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| Study Type: |
Interventional clinical trial of medicinal product
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| Study Designs: |
Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of trea
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| Start Date: |
23/09/2016
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
2 June 2020
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| Locations: |
Portugal;Slovenia;Spain;Austria;Switzerland;United Kingdom;Italy;France;Czech Republic;Canada;Mauritius;Poland;Belgium;Australia;Bulgaria;Netherlands;Germany
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| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-001979-70
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