GALAXI
Research type
Research Study
Full title
A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicentre Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease
IRAS ID
243173
Contact name
Robert Przemioslo
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2017-002195-13
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
EDMS-ERI-136754231, 1.0, EDMS number
Duration of Study in the UK
5 years, 3 months, 1 days
Research summary
Study to evaluate the safety and efficacy of a new drug for the treatment of patients with moderate to severe, active Crohn’s Disease.
This study is divided into 3 separate studies: GALAXI 1 (phase 2) which determines the dose for GALAXI 2 and 3 (identical phase 3 studies). In GALAXI 1, the participants will be randomly assigned into 1 of 5 treatment groups. Each participant will receive guselkumab, ustekinumab, or placebo depending on the study group they are placed in. In GALAXI 2/3, participants will be randomly assigned into 1 of 4 treatment groups. Each participant will receive guselkumab, ustekinumab, or placebo depending on the study group they are placed in.
The study duration is 48 weeks, with an option to include participants in a long term extension.
Approximately 2,000 participants will take place in this worldwide study.
This study is being sponsored by Janssen-Cilag International NV (JCI) Janssen Research & Development, LLC, a pharmaceutical company of Johnson & Johnson.
REC name
London - Central Research Ethics Committee
REC reference
19/LO/0397
Date of REC Opinion
5 Jun 2019
REC opinion
Further Information Favourable Opinion