Clinical trials

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NATIVE (Nash Trial to validate IVA337 Efficacy) Phase IIb trial

NASH is a severe and chronic form of non-alcoholic fatty liver disease (NAFLD), and occurs in a subgroup of patients with insulin resistance (IR) and/or metabolic syndrome such as obesity. It is estimated that 40% of NAFLD patients will progress to NASH, a disease defined as the presence of hepatic steatosis with hepatic inflammation and hepatocyte injury or ballooning, with or without fibrosis. NASH may progress to cirrhosis, liver failure and in some cases to hepatocellular carcinoma (HCC). 
 
NATIVE trial (NAsh Trial to Validate IVA337 Efficacy) is a 24 week multicenter Phase IIb clinical study that is randomized, double-blind, and placebo-controlled. The study includes two active dose arms and a placebo comparator arm. The study is currently ongoing in 12 European countries and more than 40 centers have been selected.
 
The primary endpoint is a decrease from baseline of the SAF activity score.
 
Further information on the NATIVE clinical trial is available on https://clinicaltrials.gov/ with the identifier NCT03008070
 

FASST (For A Systemic Sclerosis Treatment) Phase IIb trial

Systemic sclerosis (SSc) is a complex, multiorgan, rare disease, affecting the immune system, the microvascular system and the connective tissue.  This disease involves mostly the skin but also lung, heart, gastrointestinal tract and kidneys. Organ progressive failures make SSc a severe and lethal disease with a high death toll.

FASST study is designed to compare for 48 weeks two doses of IVA337 with a placebo control level. The study is currently recruiting in 8 European countries and more than 50 centers have been selected.

The primary end point will be the mean change of the MRSS (Modified Rodnan Skin score) from baseline to 48 weeks.

Further information on the FASST clinical trial is available on https://clinicaltrials.gov/ with the identifier NCT02503644. Please also watch the video of Professor Yannick Allanore performing the MRSS score by visiting www.fassttrial.com

 

IMPROVES (IMPROVE MPS TREATMENT) PROOF OF CONCEPT PHASE IIa TRIAL

Mucopolysaccharidoses (MPS) are a group of rare genetic disorders characterized by a deficiency of lysosomal enzymes responsible for the normal degradation of glycosaminoglycans (GAGs) or mucopolysaccharides.
 
iMProveS (Improve MPS treatment) is a 28 week proof of concept phase IIa study. The study includes two active dose arms and a placebo comparator arm. The study is currently planned to run in a maximum of three clinical centers in the European Union.
 
The primary objective of the study is to prove the safety, tolerability and efficacy of IVA336 in MPS VI patients.