A Study of Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Crohns Disease (DUET-CD)
- Conditions
- Health Condition 1: K508- Crohns disease of both small andlarge intestineHealth Condition 2: K501- Crohns disease of large intestineHealth Condition 3: K500- Crohns disease of small intestineHealth Condition 4: K509- Crohns disease, unspecified
- Registration Number
- CTRI/2023/05/052660
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1) Diagnosis of Crohns disease (CD) for at least 3 months prior to baseline
2) Confirmed diagnosis of moderate to severe CD as assessed by Crohns disease activity index (CDAI), stool frequency (SF), abdominal pain (AP) score and simple endoscopic score for Crohns disease (SES-CD)
3) Demonstrated inadequate response, loss of response, or intolerance to at least one biologic approved for the treatment of Crohns disease
4) If female and of childbearing potential, must meet the contraception and reproduction requirements
1) Complications of CD that may be anticipated to require surgery
2) 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
3) Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks
4) Has a draining (example, functioning) stoma or ostomy
5) 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 (greater than or equal to) 12 months before the first dose of study intervention)
6) 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Percentage of participants with clinical remission at Week 48 will be reported. Clinical Remission is based on the Crohns Disease Activity Index (CDAI) <br/ ><br>2) Percentage of participants with endoscopic response at Week 48 will be reported. Endoscopic response is based on change from baseline in the Simple Endoscopic Score for Crohns Disease (SES-CD)Timepoint: Week 48
- Secondary Outcome Measures
Name Time Method