PARIS
Research type
Research Study
Full title
Pharmacodynamic Activity Trial of JNJ-67484703 in Rheumatoid Arthritis, Ulcerative Colitis and Sjögren’s syndrome (PARIS) : A phase 2 proof of biology trial.
IRAS ID
1004476
Contact name
Benjamin Fisher
Contact email
Sponsor organisation
University of Birmingham
Eudract number
2021-005998-13
ISRCTN Number
ISRCTN31164692
Research summary
The aim of the PARIS Trial is to understand if JNJ-67484703, also referred to as the trial drug, can reduce the numbers of a disease-associated immune cell in diseased tissue in patients with RA, UC and SjS.This will be done by taking a small amount of diseased tissue before and after a 12 week treatment period with the study drug. The numbers of these immune cells can be measured in the biopsy tissue to understand if they are reduced by the study drug. Looking at the biopsy tissue will also allow us to see whether changes in the number of these particular immune cells are also related to changers in the overall level of inflammation. Patients will be closely monitored to see if they feel better or not on treatment and to look for side effects. For patients with RA, biopsy tissue will be obtained by using an ultrasound machine to guide a needle to take samples of the lining of the joint. For patients with UC, bowel issue will be taken during a camera test of the bowels. For patients with SjS, a small amount of salivary gland tissue will be obtained by a routine lip biopsy. All these biopsy procedures are performed regularly at the hospitals taking part in the study and will be done by someone with the appropriate training and experience. At the end of the trial, we hope to know if the trial drug acts in the way we expect.\nThe trial is for patients aged between 18-75 with either RA,UC or SjS who, based on pre-defined inclusion/exclusion criteria, have active disease and are fit enough to receive multiple doses of the trial drug. The trial is designed as a basket trial meaning the new drug will be tested in patients of different disease groups within the same clinical trial. Each disease group is referred to as a cohort.All patients will receive an injection of the trial drug under the skin 7 times over 10weeks.These injections are injected into the fatty layer just below the skin. 5 patients from each cohort will receive a low dose and 10 will receive a higher dose.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
22/SC/0128
Date of REC Opinion
25 May 2022
REC opinion
Further Information Favourable Opinion