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). 
 
The NATIVE trial (NAsh Trial to Validate IVA337 Efficacy) is a randomized, double-blind, and placebo-controlled 24 week multicenter Phase IIb clinical study. 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. Patients are being recruited. 
 
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.

The FASST study is designed to compare for 48 weeks two doses of Lanifibranor with a placebo control level over 48 weeks. 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.

Odiparcil (IVA336) is a small molecule with the potential to become the first oral substrate reduction therapy for MPS I, II and VI.

Inventiva is currently preparing a 26 week, double blinded, randomized, placebo controlled phase IIa clinical study to investigate the safety, pharmacokinetics and efficacy of oral administration of odiparcil in adult patients with MPS type VI receiving enzyme replacement therapy (ERT). The study also has an open label arm with patients currently not on ERT. The iMProveS trial will be recruiting patients at the end of the year.