GRAVITI
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Crohn's Disease
IRAS ID
1004789
Contact name
David Wright
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2020-006165-11
Clinicaltrials.gov Identifier
Research summary
Crohn’s disease is a chronic condition in which parts of the digestive tract become inflamed. 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 Crohn’s disease.
This research study is being done to see if guselkumab given subcutaneously ie, as an injection under the skin, is safe and effective in patients with moderately to severely active Crohn’s 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 total study duration is 109 weeks (about 2 years).
There are plans to recruit approximately 10 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 East - York Research Ethics Committee
REC reference
22/NE/0098
Date of REC Opinion
24 Aug 2022
REC opinion
Further Information Favourable Opinion