Monoclonal antibody NI-0101 PoC Study in Rheumatoid Arthritis
Research type
Research Study
Full title
A randomised, placebo-controlled, double blind, multicentre phase 2 study to explore tolerability, safety, pharmacokinetics, pharmacodynamics and efficacy of intravenous infusions of NI-0101, an anti-toll like receptor 4 monoclonal antibody in patients with rheumatoid arthritis.
IRAS ID
224545
Contact name
Ernest Choy
Contact email
Sponsor organisation
NovImmune S.A.
Eudract number
2016-005017-45
Duration of Study in the UK
1 years, 1 months, 0 days
Research summary
A randomised, placebo-controlled, double-blind, multicentre Phase 2b study is being conducted to find out, for the first time, what effects the investigational drug NI-0101 has on patients diagnosed with moderate to severe rheumatoid arthritis (RA) and who have an inadequate response to treatment with methotrexate (MTX). \n\nThe exact causes of RA are unknown. As it develops, an autoimmune response occurs i.e. some of the body’s immune cells start to attack healthy joint tissue, triggering a chain reaction that leads to inflammation and damage. This causes joint pain, stiffness and swelling. NI-0101 is a new monoclonal antibody, a laboratory made protein, which may block one of the signalling channels responsible for the inflammatory response. \n\nSafety, tolerability and efficacy of NI-0101 will be investigated, as well as its pharmacokinetics (what the body does with the drug i.e. absorption, distribution, metabolism and elimination) and its pharmacodynamics (what the drug does to the body i.e. effect on levels of inflammatory indicators and potential for immunogenicity against NI-0101).\n\nSubjects with special antibodies called anti-citrullinated protein antibody (ACPA) are more likely to benefit from NI-0101. Subjects must have ACPA in their blood to be included in the study. Genetics may also play an important role i.e. RA can run in families. Subjects DNA will be analysed for the 3 sub-types of FcgammaRII-131 genotype for treatment stratification purposes.\n\nUp to 45 specialised sites in up to 8 European countries (including one UK site) will participate. \n\n81 subjects will be enrolled over a 7-12 month period. Subjects who meet the study inclusion/exclusion criteria will be randomly assigned to receive either NI-0101 or placebo, while continuing to receive a stable dose of MTX. Treatment will be administered by intravenous infusions fortnightly for 6 infusions. Subjects will be followed for 12-weeks post-treatment. There will be a total of 17 visits over 7-months.\n\n
REC name
Wales REC 3
REC reference
17/WA/0145
Date of REC Opinion
15 Jun 2017
REC opinion
Further Information Favourable Opinion