DUET-CD

Summary

The purpose of the DUET-CD 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. Treatment with three different doses of the combination will be compared against treatment with guselkumab or golimumab alone (i.e., not in combination).
All reference to the words “study drug” can mean guselkumab, golimumab, a combination of guselkumab and golimumab, or placebo.

Eligibility

Currently recruiting participants: Yes

Eligible gender: Male, Female, Transgender, Other

Eligible ages: 18 to 65

Inclusion criteria:

Inclusion Criteria:

- Diagnosis of Crohn's disease (CD) for at least 3 months prior to baseline
- Confirmed diagnosis of moderate to severe CD 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
- If female and of childbearing potential, must meet the contraception and reproduction requirements

Exclusion criteria:

Exclusion Criteria:

- Complications of CD that may be anticipated to require surgery
- Currently has or is suspected to have an abscess. Recent 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 non-melanoma 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

Participate

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Method of contact

Collection of personal information
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Additional information

Contact information

Karen Graham

Principal investigator:

Remo Panaccione

Clinical trial:

Yes

REB-ID:

REB22-1064