| Trial ID: | L0380 |
| Source ID: | EUCTR2020-004986-38-FR
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| Associated Drug: |
IVA337
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| Title: |
A randomised, double-blind, placebo-controlled, multicentre, Phase 3 study evaluating long-term efficacy and safety of lanifibranor in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of live
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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: PT
Classification code 10053219
Term: Non-alcoholic steatohepatitis
System Organ Class: 10019805 - Hepatobiliary disorders
;Therapeutic area: Diseases [C] - Nutritional and Metabolic Dis
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| Interventions: |
<br>Product Name: Lanifibranor<br>Product Code: IVA337<br>Pharmaceutical Form: Film-coated tablet<br>INN or Proposed INN: lanifibranor<br>CAS Number: 927961-18-0<br>Current Sponsor code: IVA337<br>Other descriptive name: 1-(6-BENZOTHIAZOLYLSULFONYL)-5-CHL
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| Outcome Measures: |
Main Objective: Part 1<br>To assess the effect of lanifibranor compared to placebo on NASH resolution and improvement of fibrosis assessed by liver histology.<br>Part 2 <br>To assess the effect of lanifibranor compared to placebo on delaying NASH disease progression measured by a composite endpoint that includes progression to cirrhosis, liver-related clinical outcome events, or all-cause death.<br>;Secondary Objective: Key secondary objectives of Part 1<br>?€? To assess the effect of lanifibranor compared to placebo on NASH resolution and no worsening of fibrosis<br>?€? To assess the effect of lanifibranor compared to placebo on improvement of fibrosis with no worsening of NASH.<br>Other secondary objectives of both Part 1 and Part 2:<br>?€? To assess the effect of lanifibranor compared to placebo on other key histological features of NASH <br>?€? To assess the effect of lanifibranor compared to placebo on NASH resolution and improvement of fibrosis in diabetic patients <br>?€? To assess the effect of lanifibranor compared to placebo on liver function tests, glycaemic parameters, lipid parameters and liver stiffness<br>?€? To assess the effect of lanifibranor compared to placebo on health-related quality of life<br>?€? To assess the long-term safety of lanifibranor<br>?€? To assess the population PK modeling of trough plasma levels of lanifibranor ;Primary end point(s): Part 1<br>Resolution of NASH and improvement of fibrosis at Week 72, defined by NASH CRN scores for ballooning of 0 and inflammation of 0 to 1, and fibrosis score =1 stage decrease compared to Baseline.<br>Part 2<br>Time to first clinical outcome event; defined as a composite endpoint of any of the following:<br>?€? Histological progression to cirrhosis (defined as histological confirmation of fibrosis score CRN F4)<br>?€? All-cause mortality<br>?€? Liver transplant<br>?€? MELD score =15<br>?€? New onset ascites requiring treatment<br>?€? Overnight hospitalisation due to hepatic decompensation event(s) including:<br>oHepatic encephalopathy Grade =2 (as assessed by West Haven scale)<br>oVariceal bleeding<br>oSpontaneous bacterial peritonitis (assessed by positive culture or cell count)<br>;Timepoint(s) of evaluation of this end point: Part 1: from date of randomisation until the date of biopsy at Week 72.<br>Part 2: from date of randomisation until the End of Study date.Secondary end point(s): Resolution of NASH and no worsening of fibrosis at Week 70, defined by NASH CRN scores for ballooning of 0, inflammation of 0 to 1, and no fibrosis score increased compared to Baseline.<br>Improvement of fibrosis and no worsening of NASH, defined by a decrease in NASH CRN fibrosis score =1 stage from Baseline and no increase in scores for ballooning, inflammation, or steatosis.<br>Resolution of NASH and improvement of fibrosis at Week 72 and End of Study (EoS).<br>Resolution of NASH and no worsening of fibrosis at Week 72 and EoS.<br>Improvement of fibrosis and no worsening of NASH at Week 72 and EoS.<br>Improvement of NASH CRN fibrosis stage by at least 2 points and no worsening of NASH (no increase in scores for steatosis, ballooning, or lobular inflammation) at Week 72 and EoS.<br>Resolution of fibrosis, defined as NASH CRN fibrosis stage 0, at Week 72 and EoS.<br>Improvement in NAFLD Activity Score (NAS) by at least 2 points (at least a 1-point reduction in either lobular inflammation or hepatocellular ballooning) and no worsening of fibrosis at Week 72 and EoS.<br>Improvement of each histological feature of NASH by at least 1 point (steatosis, lobular inflammation, hepatocellular ballooning) and no worsening of fibrosis at Week 72 and EoS.<br>NASH resolution and improvement of fibrosis at Week 72 and EoS, in the subgroup of diabetics.<br>Change from Baseline in liver function tests (AST, ALT, GGT, ALP, direct and total bilirubin).<br>Change from Baseline in liver stiffness by elastography (only at sites with suitable equipment).<br>;Timepoint(s) of evaluation of this end point: Part 1 : Date of randomisation until the date of biopsy at Week 72 visit.<br>Part 2: Date of randomisation until the EoS date.
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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 3
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| Enrollment: |
2000
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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: |
09/07/2021
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
10 January 2022
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| Locations: |
United States;Portugal;Spain;Ukraine;Israel;Italy;France;Denmark;Australia;South Africa;Netherlands;Czechia;Finland;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Romania;Bulgaria;Germany;Norway;Sweden
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| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-004986-38
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