TRIDENT Study
Research type
Research Study
Full title
A Phase 2b, Randomised, Double-blind, Placebo-controlled, Parallel-group, Multicentre Protocol to Evaluate the Safety and Efficacy of JNJ-64304500 in Subjects with Moderately to Severely Active Crohn’s Disease.
IRAS ID
207367
Contact name
Minal Kara
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2016-000634-21
Duration of Study in the UK
3 years, 7 months, 13 days
Research summary
Crohn's disease is a long-term condition that causes inflammation of the lining of the digestive system. Inflammation can affect any part of the digestive system, but most commonly occurs in the last section of the small intestine or the large intestine.
The purpose of part I of the study is to see if JNJ 6430450, the study drug is useful for treating patients with moderately to severely active Crohn’s Disease. The study is also done to see if JNJ-64304500, is safe to take without causing too many side effects. In addition to this the purpose of Part II is to find the dose of JNJ 64304500 that best treats moderately to severely active Crohn’s Disease and to understand patient responses to Crohn’s diseases treatments using an approved drug called ustekinumab.
This is double-blinded study meaning that neither the participant and the study doctor will know which medication is being given. The study is randomised, meaning that participants will be randomly assigned to receive either JNJ-64304500, or placebo in part 1 or JNJ-64304500, placebo or ustekinumab in part II.
Janssen Research & Development, LLC is the sponsor of this study which will take place worldwide. It is anticipated that approximately 200 participants will be enrolled in Part I and an additional 250 participants will be enrolled in Part II.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
16/EE/0356
Date of REC Opinion
11 Nov 2016
REC opinion
Further Information Favourable Opinion