Clinical Trials List
2022-11-30 - 2028-12-31
Phase II
Not yet recruiting4
ICD-10K50.00
Crohn's disease of small intestine without complications
ICD-10K50.011
Crohn's disease of small intestine with rectal bleeding
ICD-10K50.018
Crohn's disease of small intestine with other complication
ICD-10K50.019
Crohn's disease of small intestine with unspecified complications
ICD-9555.0
Regional enteritis, small intestine
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
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Trial Applicant
PAREXEL INTERNATIONAL CO., LTD.
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 翁孟慈 Division of General Internal Medicine
- CHIEN-CHIH TUNG Division of General Internal Medicine
- Huey-Ling Chen Division of General Internal Medicine
- 謝銘鈞 Division of General Internal Medicine
- YEN-HSUAN NI Division of General Internal Medicine
- 吳嘉峯 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 張安迪 Digestive System Department
- Chun-Lung Feng Digestive System Department
- Tsung-Yu Tsai Digestive System Department
- 吳宜樺 Digestive System Department
- 黃柏儒 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Golimumab
Guselkumab and Golimumab
Dosage Form
Prefilled syringe with UltraSafe
Prefilled syringe with UltraSafe Plus
Dosage
100 mg/mL
100mg Guselkumab and 100mg Golimumab/2mL
Endpoints
The percentage of participants with endoscopic response at Week 48 will be reported. Endoscopic response was based on the Simplified Endoscopic Score for Crohn's disease (SES-CD).
Inclution 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
Complications of CD 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
The Estimated Number of Participants
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Taiwan
12 participants
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Global
715 participants
