NovImmune: Open label study of NI-0801 in Primary Biliary Cirrhosis

• Research type

  Research Study

• Full title

  PIANO Primary Biliary Cirrhosis: Investigating A New Treatment Option using NI 0801, a fully human anti-CXCL10 monoclonal antibody. An open label single arm study to investigate the safety and efficacy of multiple administrations of NI-0801, a fully human anti-CXCL10 monoclonal antibody in primary biliary cirrhosis patients with an incomplete response to ursodeoxycholic acid.

• IRAS ID

  76891

• Contact name

  David Adams

• Sponsor organisation

  NovImmune S.A.

• Eudract number

  2011-001326-26

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  In primary biliary cirrhosis (PBC) damage occurs to the tubes (bile ducts) which transport bile (this aids digestion) from the liver to the gut. The resulting build up of bile damages the liver by causing inflammation and scarring. Over time this damage becomes extensive and may result in the liver being unable to repair, which is known as cirrhosis, eventually leading to liver failure.Currently the only approved treatment for PBC is ursodeoxycholic acid (UDCA) which does not address the underlying cause of the disease and does not treat the common symptoms of the disease (fatigue and itching). About 40% of PBC patients have a suboptimal response to UDCA.NI-0801 is an experimental drug which is an antibody. Antibodies are proteins that are produced in the body to bind to and neutralise foreign substances including bacteria and viruses. The antibody, NI-0801 has been designed to bind to and inactivate a protein called CXCL10 which is involved in stimulating harmful inflammation in PBC. If CXCL10 is inactivated by NI-0801 this is expected to reduce the inflammation in the liver.Forty patients who have had an incomplete response to UDCA will be dosed. Each will receive six infusions of the study drug, one every two weeks, in addition to UDCA treatment. There will then be a follow up period for three months.The objectives of this study are: - To investigate the efficacy (effectiveness) of multiple doses of NI 0801 on liver function- To evaluate the safety and tolerability of multiple doses of NI-0801 in PBC patients- To characterise the pharmacokinetic (what the body does to the drug) and pharmacodynamic (what the drug does to the body) profile of multiple doses of NI-0801.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  11/EM/0115

• Date of REC Opinion

  27 May 2011

• REC opinion

  Further Information Favourable Opinion