NSCIBD Clinical Studies
DUET-CD (Crohn's)/DUET-UC (Ulcerative Colitus)
The purpose of the DUET-CD/DUET-UC study is to see if the combination of guselkumab and golimumab is safe and effective for treating patients with moderately to severely active Crohn’s disease/ Ulcerative Colitis. We are looking for participants who have had a diagnosis of moderate to severe Crohn’s Disease or Ulcerative Colitis for at least three months.
The treatments being studied in this clinical trial are called guselkumab, golimumab and a combination of both currently known as JNJ-7893480.
Guselkumab works by blocking an inflammatory protein made by the immune cells called interleukin (IL)-23 and Golilumab works by blocking an inflammatory protein made by immune cells called tumor necrosis factor (TNF). JNJ-78934804 works by blocking both IL-23 and TNF.
It has been proposed that combination therapies, such as JNJ-78934804 may be more effective in inducing and maintaining remission in Crohn’s Disease/Ulcerative Colitis than monotherapies (one treatment).
- Diagnosis of Crohn's disease (CD) or Ulcerative Colitis (UC) for at least 3 months prior to baseline
- Confirmed diagnosis of moderate to severe CD/UC as assessed by Crohn's disease activity index (CDAI), stool frequency (SF), abdominal pain (AP) score and simple endoscopic score for Crohn's disease (SES-CD)
- Demonstrated inadequate response, loss of response, or intolerance to at least one biologic approved for the treatment of Crohn's disease/Ulcerative Colitis (UC)
- If female and of childbearing potential, must meet the contraception and reproduction requirements
- Complications of CD/UC that may be anticipated to require surgery
- Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery
- Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks
- Has a draining (example, functioning) stoma or ostomy
- Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer or cervical carcinoma in situ that has been adequately treated with no evidence of recurrence for greater than or equal do (>=) 12 months before the first dose of study intervention)
- Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infections (example, pyelonephritis, cystitis), an open, draining, or infected skin wound, or an ulcer
Interested in learning more about these clinical studies?
For clinical studies, please contact Lorena Morrison (Research Manager) or Shari Smith (Senior Clinical Research Coordinator) at:
Centre for Clinical Research
5790 University Avenue Room 321D
Halifax, NS B3H 1V7