DUET-CD
Research type
Research Study
Full title
A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Crohn’s Disease
IRAS ID
1005939
Contact name
David Wright
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2021-003314-39
Clinicaltrials.gov Identifier
Research summary
This research study is being done to see if guselkumab, golimumab or the combination of guselkumab and golimumab is safe and effective for treating participants with moderately to severely active Crohn’s Disease.
Guselkumab is currently in phase 3 studies for both Crohn’s disease and ulcerative colitis. It is not approved for the treatment of Crohn’s disease at this time by any Regulatory Authority in any country.
Golimumab has been approved in countries worldwide for the treatment of moderately to severely active ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. It has not been approved for the treatment of Crohn’s disease by any Regulatory Authority in any country.
The combination of guselkumab and golimumab works by blocking both IL-23 and TNF, chemical messengers that regulate inflammation and are present in excessive amounts in patients with active Crohn’s disease. This combination has been studied in ulcerative colitis and is currently being studied in psoriatic arthritis. The combination of guselkumab and golimumab is not yet approved for Crohn’s disease by any Regulatory Authority in any country.
Participants will randomly be put into 1 of 6 treatment groups. These groups include a Placebo, guselkumab, golimumab, combination of guselkumab and golimumab (high dose), combination of guselkumab and golimumab (mid dose) or combination of guselkumab and golimumab (low dose).
The main study consists of Screening, Treatment, and Long-Term Extension (LTE) periods. The treatment period of the study will evaluate 48 weeks of therapy with guselkumab/golimumab co-formulation. All participants who are not responding based on defined measures at Week 24, including those assigned to the placebo Group will have the opportunity for an increase in the level of treatment to mid or high-dose combination.
This study is being sponsored by Janssen-Cilag International NV, a pharmaceutical company of Johnson & Johnson.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
22/SC/0334
Date of REC Opinion
28 Dec 2022
REC opinion
Further Information Favourable Opinion