FUZION
Research type
Research Study
Full title
A Phase 3, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab in Participants with Fistulizing, Perianal Crohn’s Disease
IRAS ID
1005481
Contact name
David Wright
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2021-000491-10
ISRCTN Number
ISRCTN15970897
Clinicaltrials.gov Identifier
Research summary
Crohn’s disease is a chronic condition in which parts of the digestive tract become inflamed and is occasionally complicated by channels forming. These connect the anal canal or rectum to the surface of the skin near the anus. This is known as perianal fistulizing Crohns Disease.
Current available treatments are not effective or lose effectiveness after a while in most people, therefore there is a need to research other medications that can provide long-term remission. Targeting a chemical pathway called interleukin (IL)-23 pathway may control inflammatory bowel disease. Guselkumab inhibits IL-23 and could be a new treatment for perianal fistulizing Crohn’s disease.
This research study is being done to see if guselkumab is safe and effective in patients with perianal fistulizing Crohns Disease.
Guselkumab has been approved in the United Kingdom for the treatment of adults with moderate to severe plaque psoriasis (an inflammatory skin condition) and psoriatic arthritis (an inflammatory condition that affects mostly joints and skin). It is not approved for Crohn’s disease by any Regulatory Authority in any country.
There are 3 treatment groups in this study; 2 are guselkumab treatment groups and 1 is a placebo group. Participants in the study will be randomly assigned into 1 of the 3 treatment groups. Each participant will receive 1 of 2 specified guselkumab treatment regimens or placebo every 4 weeks. The main study duration is approximately 70 weeks (about 1.5 years). Should a participant be responding at the end of the main study there is also the option to enter an extension study for approximately one year.
There are plans to recruit approximately 16 participants from 8 sites within the UK.
This study is being sponsored by Janssen-Cilag International NV (JCI), a pharmaceutical company of Johnson & Johnson.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
22/NW/0169
Date of REC Opinion
19 Jul 2022
REC opinion
Further Information Favourable Opinion