A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
Colitis, UlcerativeThe purpose of this study is to evaluate the efficacy and safety of JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial response, loss of response, or intolerance to one or more approved advanced therapy.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 to 65
Participation Criteria
Inclusion 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)
Study Location
Columbia Gastroenterology
Columbia GastroenterologyNew Westminster, British Columbia
Canada
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Health Sciences Centre
Health Sciences CentreWinnipeg, Manitoba
Canada
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Toronto Immune & Digestive Health Institute Inc.
Toronto Immune & Digestive Health Institute Inc.Toronto, Ontario
Canada
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St. Jerome Medical Research
St. Jerome Medical ResearchSaint-Jerome, Quebec
Canada
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Covenant Health/Grey Nuns hospital
Covenant Health/Grey Nuns hospitalEdmonton, Alberta
Canada
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PerCuro Clinical Research Ltd.
PerCuro Clinical Research Ltd.Victoria, British Columbia
Canada
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London Health Sciences Centre - University Campus
London Health Sciences Centre - University CampusLondon, Ontario
Canada
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McGill University - Health Centre - Montreal General Hospital
McGill University - Health Centre - Montreal General HospitalMontreal, Quebec
Canada
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Gastroenterology and Internal Medicine Research Institute (GIRI)
Gastroenterology and Internal Medicine Research Institute (GIRI)Edmonton, Alberta
Canada
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GIRI Gastrointestinal Research Institute
GIRI Gastrointestinal Research InstituteVancouver, British Columbia
Canada
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Nova Scotia Health Authority
Nova Scotia Health AuthorityHalifax, Nova Scotia
Canada
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CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve RosemontMontreal, Quebec
Canada
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Foothills Hospital
Foothills HospitalCalgary, Alberta
Canada
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The Gordon & Leslie Diamond Health Care Center
The Gordon & Leslie Diamond Health Care CenterVancouver, British Columbia
Canada
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Viable Clinical Research
Viable Clinical ResearchDartmouth, Nova Scotia
Canada
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CMIIM, Centre médical L'Enjeu
CMIIM, Centre médical L'EnjeuMont-Royal, Quebec
Canada
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- Study Sponsored By
- Janssen Research & Development, LLC
- Participants Required
- More Information
- Study ID:
NCT05242484