4064 NNC0109-0012 (anti-IL-20 mAb) Mechanism of Action Study
Research type
Research Study
Full title
A randomised, active comparator, double-blind, multi centre, parallel, phase 2a trial, investigating the mechanism of action, of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to Methotrexate
IRAS ID
139593
Contact name
Peter Taylor
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2013-001492-20
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
The drug that is researched in this study is called Anti-Interleukin-20 (NNC0109-0012, hereinafter called Anti-IL-20). Anti-IL-20 prevents the binding of a pro-inflammatory molecule called Interleukin-20 (hereafter called IL-20) to the IL-20 receptor, which is present at high levels in the joints and is believed to be involved in the development of rheumatoid arthritis (RA).
The purpose of this study is to determine Anti-IL-20 (the study drug) works to control inflammation and to learn about how Anti-IL-20 interacts with the body in subjects with RA. Anti-IL-20 has already been given in various doses from 0.01 to 3.0 mg/kg to a total of 121 subjects in four finalised clinical studies conducted by Novo Nordisk (subjects with rheumatoid arthritis as well as healthy volunteers and subjects diagnosed with psoriasis). During these studies, Anti-IL-20 was well tolerated with a low increased risk of infections and injection site reactions. The mechanism of action will be explored using the latest imaging techniques, namely ultrasound and magnetic resonance imaging (MRI) as well as by taking synovial biopsies from inflamed joints.
The study will last for approximately 27 weeks which consists of a 3 week screening period, a 12 week treatment period and a 12 week off medication observational follow-up period. Patients will ask to attend for clinic visits at least 17 times during the course of the study.
Patients will be allocated by random to receive either the study drug, anti-IL-20, or a comparator drug which is available commercially, adulimumab (Humira®). Neither the patient nor their study doctor or nurse will know which drug they have been allocated to. During the 12 week treatment period, patients will receive weekly subcutaneous injections of the study drug at their clinic visits.
This study will include approximately 42 subjects with rheumatoid arthritis from different hospitals in up to 4 countries.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
13/SC/0554
Date of REC Opinion
24 Dec 2013
REC opinion
Further Information Favourable Opinion