Clinical Trials List
2022-11-30 - 2028-12-31
Phase II
Not yet recruiting5
Recruiting1
ICD-10K51.90
Ulcerative colitis, unspecified, without complications
ICD-10K51.911
Ulcerative colitis, unspecified with rectal bleeding
ICD-10K51.912
Ulcerative colitis, unspecified with intestinal obstruction
ICD-10K51.913
Ulcerative colitis, unspecified with fistula
ICD-10K51.914
Ulcerative colitis, unspecified with abscess
ICD-10K51.918
Ulcerative colitis, unspecified with other complication
ICD-10K51.919
Ulcerative colitis, unspecified with unspecified complications
ICD-9556.9
Ulcerative colitis, unspecified
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 Ulcerative Colitis
-
Trial Applicant
PAREXEL INTERNATIONAL CO., LTD.
-
Sponsor
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 謝銘鈞 Division of General Internal Medicine
- YEN-HSUAN NI Division of General Internal Medicine
- Huey-Ling Chen Division of General Internal Medicine
- 吳嘉峰 Division of General Internal Medicine
- 翁孟慈 Division of General Internal Medicine
- CHIEN-CHIH TUNG 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
- 黃柏儒 Digestive System Department
- 張安迪 Digestive System Department
- Tsung-Yu Tsai Digestive System Department
- 吳宜樺 Digestive System Department
- Chun-Lung Feng Digestive System Department
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 陳家昌 Division of General Internal Medicine
- FAN -FENG CHIANG Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Cheng-Yu Lin Digestive System Department
- 許振銘 Digestive System Department
- Puo-Hsien Le Digestive System Department
- Chia-Jung Kuo Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Golimumab
Guselkumab and Golimumab co-formulation
Dosage Form
Prefilled syringe with UltraSafe
Prefilled syringe with UltraSafe Plus
Dosage
100 mg/mL
100mg Guselkumab and 100mg Golimumab/2mL
Endpoints
Inclution Criteria
Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline
Moderately to severely active UC as assessed by the modified Mayo score
Demonstrated inadequate response, loss of response, or intolerance to at least one biologic or novel oral with biologic-like activity
If female and of childbearing potential, must meet the contraception and reproduction requirements
Exclusion Criteria
Has severe extensive colitis as defined in the protocol
Extent of inflammatory disease limited to the rectum
Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease (CD)
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
Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 months of first dose of study intervention)
The Estimated Number of Participants
-
Taiwan
6 participants
-
Global
550 participants
