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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03008070
Registration number
NCT03008070
Ethics application status
Date submitted
22/12/2016
Date registered
2/01/2017
Date last updated
19/07/2023
Titles & IDs
Public title
Phase 2b Study in NASH to Assess IVA337
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Scientific 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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Secondary ID [1]
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2016-001979-70
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Secondary ID [2]
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IVA_01_337_HNAS_16_002
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Universal Trial Number (UTN)
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Trial acronym
NATIVE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Alcoholic Steatohepatitis (NASH)
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Condition category
Condition code
Oral and Gastrointestinal
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Metabolic and Endocrine
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Metabolic disorders
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Diet and Nutrition
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0
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Obesity
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - IVA337
Treatment: Drugs - IVA337
Treatment: Drugs - Placebo
Experimental: IVA337 1200mg - IVA337 400mg, once a day (Quaque Die, QD) with food
Experimental: IVA337 800mg - IVA337 400mg, once a day (Quaque Die, QD) with food
Placebo Comparator: Placebo - Placebo to match, once a day (Quaque Die, QD) with food
Treatment: Drugs: IVA337
1200mg
Treatment: Drugs: IVA337
800mg
Treatment: Drugs: Placebo
Placebo to match
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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SAF Activity Score (SAF-A) Decrease of at Least 2 Points With no Worsening of the CRN Fibrosis Score (CRN-F)
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Assessment method [1]
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SAF-A is the activity part of the Steatosis Activity Fibrosis [SAF] histological score, calculated as the sum of lobular inflamation score and balloning score.
No worsening of fibrosis means that the CRN fibrosis score (CRN-F) remains stable or decreases.
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Timepoint [1]
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24 weeks
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Secondary outcome [1]
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NASH Improvement
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Assessment method [1]
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NASH improvement is defined as a decrease of at least 2 points in NAS score (sum of CRN Steatosis, Inflammation and Ballooning scores) without worsening of CRN Fibrosis score.
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Timepoint [1]
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24 weeks
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Secondary outcome [2]
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NASH Resolution and no Worsening of Fibrosis
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Assessment method [2]
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Resolution of NASH is defined as a CRN Inflammation score equal to 0 or 1, and a CRN Ballooning score equal to 0. No worsening of fibrosis means that the CRN fibrosis score remains stable or decreases.
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Timepoint [2]
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24 weeks
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Secondary outcome [3]
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Improvement of Fibrosis by at Least 1 Stage and no Worsening of NASH
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Assessment method [3]
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Improvement of fibrosis is defined as a decrease of at least one stage in CRN Fibrosis score. No worsening of NASH is defined as no increase of CRN Steatosis score, no increase of CRN Inflammation score ans no increase of CRN Ballooning score.
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Timepoint [3]
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24 weeks
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Secondary outcome [4]
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Activity (SAF-A) Improvement
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Assessment method [4]
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SAF-A is the activity part of the Steatosis Activity Fibrosis [SAF] histological score, calculated as the sum of lobular inflamation score and balloning score. Improvement of SAF-A is defined as a decrease of at least 1 point.
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Timepoint [4]
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24 weeks
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Secondary outcome [5]
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Steatosis (CRN-S) Improvement
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Assessment method [5]
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Improvement of CRN Steatosis score (CRN-S) is defined as a decrease of at least 1 point.
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Timepoint [5]
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24 weeks
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Secondary outcome [6]
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Lobular Inflammation (CRN-I) Improvement
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Assessment method [6]
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Improvement of CRN Lobular inflammation score (CRN-I) is defined as a decrease of at least 1 point.
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Timepoint [6]
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24 weeks
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Secondary outcome [7]
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Hepatocyte Balooning (CRN-B) Improvement
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Assessment method [7]
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Improvement of CRN Ballooning (CRN-B) is defined as a decrease of at least 1 point.
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Timepoint [7]
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24 weeks
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Secondary outcome [8]
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Fibrosis (CRN-F) Improvement
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Assessment method [8]
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Improvement of CRN Fibrosis score (CRN-F) is defined as a decrease of at least 1 point.
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Timepoint [8]
0
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24 weeks
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Secondary outcome [9]
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Modified ISHAK Fibrosis (ISHAK-F) Improvement
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Assessment method [9]
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Improvement of Modified ISHAK Fibrosis (ISHAK-F) is defined as a decrease of at least 1 point.
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Timepoint [9]
0
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24 weeks
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Secondary outcome [10]
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Absolute Change in ALT
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Assessment method [10]
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Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.
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Timepoint [10]
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24 weeks
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Secondary outcome [11]
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Absolute Change in AST
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Assessment method [11]
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Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.
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Timepoint [11]
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24 weeks
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Secondary outcome [12]
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Absolute Change in GGT
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Assessment method [12]
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Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.
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Timepoint [12]
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24 weeks
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Secondary outcome [13]
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Absolute Change in Fibrinogen
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Assessment method [13]
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Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.
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Timepoint [13]
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24 weeks
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Secondary outcome [14]
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Absolute Change in Hs-CRP
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Assessment method [14]
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Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.
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Timepoint [14]
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24 weeks
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Secondary outcome [15]
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Absolute Change in Alpha2 Macroglobulin
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Assessment method [15]
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Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.
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Timepoint [15]
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24 weeks
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Secondary outcome [16]
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Absolute Change in Haptoglobulin
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Assessment method [16]
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Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.
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Timepoint [16]
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24 weeks
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Secondary outcome [17]
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Absolute Change of Fasting Plasma Glucose
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Assessment method [17]
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Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.
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Timepoint [17]
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24 weeks
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Secondary outcome [18]
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Absolute Change in Insulin
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Assessment method [18]
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Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.
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Timepoint [18]
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24 weeks
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Secondary outcome [19]
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Absolute Change in HOMA Index
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Assessment method [19]
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Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.
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Timepoint [19]
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24 weeks
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Secondary outcome [20]
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Absolute Change in HbA1c
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Assessment method [20]
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Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.
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Timepoint [20]
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24 weeks
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Secondary outcome [21]
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Absolute Change in Total Cholesterol
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Assessment method [21]
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Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.
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Timepoint [21]
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24 weeks
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Secondary outcome [22]
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Absolute Change of HDL-Cholesterol
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Assessment method [22]
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Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.
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Timepoint [22]
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24 weeks
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Secondary outcome [23]
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Absolute Change of LDL-Cholesterol
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Assessment method [23]
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Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.
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Timepoint [23]
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24 weeks
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Secondary outcome [24]
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Absolute Change in Triglycerides
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Assessment method [24]
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Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.
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Timepoint [24]
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24 weeks
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Secondary outcome [25]
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Absolute Change in Apo A1
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Assessment method [25]
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Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.
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Timepoint [25]
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0
24 weeks
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Secondary outcome [26]
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Absolute Change in Adiponectin
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Assessment method [26]
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Absolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.
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Timepoint [26]
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24 weeks
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Secondary outcome [27]
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Resolution of NASH and Improvement of Fibrosis by at Least 1 Stage
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Assessment method [27]
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Resolution of NASH is defined as a CRN Inflammation score equel to 0 or 1, and a CRN ballooning score equal to 0. Improvement of firbosis is defined as a decrease of at least one stage in CRN Fibrosis score.
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Timepoint [27]
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From baseline to Week 24.
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Eligibility
Key inclusion criteria
- Adult subjects, age =18 years.
- NASH histological diagnosis according to the currently accepted definition of both
EASL and AASLD, requiring the combined presence of steatosis (any degree = 5%) +
lobular inflammation of any degree + liver cell ballooning of any amount, on a liver
biopsy performed = 6 months before screening in the study or at screening and
confirmed by central reading during the screening period and
- SAF Activity score of 3 or 4 (>2)
- SAF Steatosis score = 1
- SAF Fibrosis score < 4
- Subject agrees to have a liver biopsy performed after 24 weeks of treatment.
- Compensated liver disease
- No other causes of chronic liver disease (autoimmune, primary biliary cholangitis,
Hepatitis B virus (HBV), hepatitis C virus (HCV), Wilson's, a-1-antitrypsin
deficiency, hemochromatosis, etc…).
- If applicable, have a stable type 2 diabetes, defined as HbA1c = 8.5% and fasting
glycemia <10 mmol/L, no changes in medication in the previous 6 months, and no new
symptoms associated with decompensated diabetes in the previous 3 months.
- Have a stable weight since the liver biopsy was performed defined by no more than a 5
% loss of initial body weight.
- Negative pregnancy test or post-menopausal. Women with childbearing potential (i.e.
fertile, following menarche and until becoming post-menopausal unless permanently
sterile) must be using a highly effective method of contraception (i.e. combined
(estrogen and progestogen containing) hormonal/ progestogen-only hormonal
contraception associated with inhibition of ovulation, intrauterine device,
intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised
partner). The contraceptive method will have to be followed for at least one
menstruation cycle after the end of the study
- Subjects having given her/his written informed consent.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Evidence of another form of liver disease.
- History of sustained excess alcohol ingestion: daily alcohol consumption > 30 g/day (3
drinks per day) for males and > 20 g/day (2 drinks per day) for females.
- Unstable metabolic condition: Weight change > 5kg in the last three months, diabetes
with poor glycemic control (HbA1c > 8.5%), introduction of an antidiabetic or of an
anti-obesity drug/malabsorptive or restrictive bariatric (weight loss) surgery in the
past 6 months prior to screening.
- History of gastrointestinal malabsorptive bariatric surgery within less than 5 years
or ingestion of drugs known to produce hepatic steatosis including corticosteroids,
high-dose estrogens, methotrexate, tetracycline or amiodarone in the previous 6
months.
- Significant systemic or major illnesses other than liver disease, including congestive
heart failure (class C and D of the American Heart Association , AHA), unstable
coronary artery disease, cerebrovascular disease, pulmonary disease, renal failure,
organ transplantation, serious psychiatric disease, malignancy that, in the opinion of
the investigator, would preclude treatment with IVA337 and/or adequate follow up.
- HB antigen >0, HCV Polymerase chain reaction (PCR) tests >0 (patients with a history
of HCV infection can be included if HCV PCR is negative since more than 3 years), HIV
infection.
- Pregnancy/lactation or inability to adhere to adequate contraception in women of
child-bearing potential.
- Active malignancy except cutaneous basocellular carcinoma.
- Any other condition which, in the opinion of the investigator would impede competence
or compliance or possibly hinder completion of the study.
- Body mass index (BMI) >45 kg/m2.
- Type 1 diabetes and type 2 diabetic patient on insulin.
- Diabetic ketoacidosis
- Fasting Triglycerides > 300 mg/dL.
- Hemostasis disorders or current treatment with anticoagulants.
- Contra-indication to liver biopsy.
- History of, or current cardiac dysrhythmias and/or a history of cardiovascular disease
event, including myocardial infarction, except patients with only well controlled
hypertension. Any clinically significant ECG abnormality reported by central ECG
reading.
- Participation in any other clinical study within the previous 3 months.
- Have a known hypersensitivity to any of the ingredients or excipients of the
Investigational medicinal product (IMP)
- Be possibly dependent on the Investigator or the sponsor (e.g., including, but not
limited to, affiliated employee).
- Creatine phosphokinase (CPK)>5 x ULN
- Osteopenia or any other well documented Bone disease. Patient without well documented
osteopenia treated with vitamin D and/or Calcium based supplements for preventive
reasons can be included.
(The criteria below are applicable only for patients who will undergo a MRI/LMS in selected
centers)
- Claustrophobia to a degree that prevents tolerance of MRI scanning procedure. Sedation
is permitted at discretion of investigator.
- Metallic implant of any sort that prevents MRI examination including, but not limited
to: aneurysm clips, metallic foreign body, vascular grafts or cardiac implants, neural
stimulator, metallic contraceptive device, tattoo, body piercing that cannot be
removed, cochlear implant; or any other contraindication to MRI examination.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/02/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
16/03/2020
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Sample size
Target
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Accrual to date
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Final
247
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Flinders Medical Centre Department of Hepatology - Bedford Park
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Recruitment hospital [2]
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Monash Medical Centre - Clayton
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Recruitment hospital [3]
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Lyell McEwin Hospital & The University of Adelaide - Elizabeth Vale
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Recruitment hospital [4]
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Royal Brisbane and Women's Hospital - Herston
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Recruitment hospital [5]
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Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
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SA 5042 - Bedford Park
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Recruitment postcode(s) [2]
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3168 - Clayton
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Recruitment postcode(s) [3]
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SA 5112 - Elizabeth Vale
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Recruitment postcode(s) [4]
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- Herston
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Recruitment postcode(s) [5]
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WA 6150 - Murdoch
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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0
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United States of America
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California
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United States of America
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Florida
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United States of America
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Massachusetts
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United States of America
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North Carolina
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0
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
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Austria
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Vienna
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Belgium
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Brussels
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0
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Belgium
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Edegem
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Belgium
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Genk
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Belgium
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Gent
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Bulgaria
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Sofia
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Canada
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Calgary
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Canada
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Edmonton
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Canada
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Greenfield Park
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Canada
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London
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Canada
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Montréal
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Canada
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Vancouver
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Czechia
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Plzen
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Czechia
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Praha
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France
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Angers
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France
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Besancon
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France
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Bordeaux
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France
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Créteil
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France
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Grenoble
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France
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Lyon
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France
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Montpellier
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France
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Nice
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France
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Paris
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France
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Rennes
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France
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Strasbourg
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France
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Toulouse
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Germany
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Aachen
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Germany
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Freiburg
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Germany
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Heidelberg
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Germany
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Mainz
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Germany
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Münster
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Germany
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Wurzburg
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Italy
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Ancona
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Italy
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Milano
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Italy
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Palermo
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Italy
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Roma
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Italy
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San Giovanni Rotondo
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Italy
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Torino
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Mauritius
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Quatre Bornes
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Poland
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Katowice
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Poland
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Lodz
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Poland
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Lublin
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Slovenia
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Celje
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Slovenia
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Murska Sobota
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Barcelona
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Santander
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Spain
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Sevilla
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Switzerland
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Bern
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Switzerland
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Lugano
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United Kingdom
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London
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United Kingdom
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Newcastle
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United Kingdom
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Nottingham
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Inventiva Pharma
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Summary
Brief summary
Non-alcoholic steatohepatitis, abbreviated as NASH, is a chronic liver disease that may
progress to cirrhosis. The disease is mostly associated with obesity and type 2 diabetes
mellitus, or insulin resistance and is very common. However, Treatment of NASH is a
significant unmet clinical need.
IVA337 (lanifibranor) is a next generation pan-PPAR (peroxisome proliferator-activated
receptors) agonist addressing the pathophysiology of NASH : metabolic, inflammatory and
fibrotic.
The purpose of this research is to evaluate the efficacy and the safety of two doses of
IVA337 (800mg, 1200 mg) per day for 24 weeks versus placebo in adult NASH patients with liver
steatosis and moderate to severe necroinflammation without cirrhosis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03008070
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Public notes
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Contacts
Principal investigator
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Sven FRANCQUE, MD, PhD
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Division of Gastroenterology and Hepatology, Antwerp University Hospital, Wilrijkstraat 10, B-2650 Edegem, Belgium
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03008070
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