Randomized, Multicenter Study of Combination Medications to Treat Active Crohn’s Disease (DUET-CD)
- Study HIC#:2000033990
- Last Updated:11/17/2023
In this study, volunteers will be randomized to be treated with 1 of 2 different medications or a combination of both medications to see what medication works best and if there are any safety concerns when using both medications at the same time.
- Age18 years - 65 years
- GenderBoth
Contact Us
For more information about this study, including how to volunteer, contact:
Elizabeth Ruggiero
- Phone Number: 1-203-785-7573
Help Us Discover!
You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.
Trial Purpose and Description
The primary hypothesis is that the co-formulation of guselkumab and golimumab (JNJ-78934804) is superior to both guselkumab and golimumab alone as measured by the co-primary endpoints of clinical remission (Crohn s Disease Activity Index [CDAI] score <150) at Week 48 and endoscopic response (≥50% improvement from baseline in the Simple Endoscopic Score for Crohn s Disease [SES-CD] score) at Week 48 for the treatment of participants with moderately to severely active Crohn s disease (CD) who have had an inadequate initial response, loss of response, or intolerance to ≥1 advanced therapy (ADT), defined as a biologic
Eligibility Criteria
18-75 years of age, and a confirmed diagnosis of Crohn’s disease with active symptoms.