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
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Une étude multicentrique parallèle, contrôlée par placebo actif et double aveugle randomisée de phase 2b pour évaluer l'efficacité et la sécurité de la thérapie combinée d'induction et de maintenance avec Guselkumab et Golimumab chez les participants atteints de colite ulcéreuse modérément à sévèrement active
* 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)
Cohorts
Proposed Therapy or Intervention
Data not available
Cohorts
Centre intégré de santé et de services sociaux des Laurentides
Data not available
Current data since :
March 28, 2024 00:17
Centre intégré universitaire de santé et de services sociaux de l'Est-de-l'Île-de-Montréal
Data not available
Current data since :
September 26, 2023 10:58
Centre hospitalier de l'Université de Montréal
Data not available
Current data since :
September 26, 2023 10:58
Centre intégré universitaire de santé et de services sociaux du Saguenay–Lac-Saint-Jean
Data not available
Current data since :
October 31, 2023 14:45
Centre universitaire de santé McGill
Data not available
Current data since :
February 09, 2024 11:38
other centers
Name
Medical condition
Treatment
Recruitment status
Group 1: Placebo
Participants will receive placebo subcutaneously (SC). All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Data not available
Unknown
Group 2: Guselkumab
Participants will receive guselkumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Data not available
Unknown
Group 3: Golimumab
Participants will receive golimumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Data not available
Unknown
Group 4: JNJ-78934804 (High-dose)
Participants will receive JNJ-78934804 dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Data not available
Unknown
Group 5: JNJ-78934804 (Mid-dose)
Participants will receive JNJ-78934804 dose regimen 2 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Data not available
Unknown
Group 6: JNJ-78934804 (Low-dose)
Participants will receive JNJ-78934804 dose regimen 3 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Data not available
Unknown
Group 1: Placebo
Recruitment status
unknown
Participants will receive placebo subcutaneously (SC). All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Group 2: Guselkumab
Recruitment status
unknown
Participants will receive guselkumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Group 3: Golimumab
Recruitment status
unknown
Participants will receive golimumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Group 4: JNJ-78934804 (High-dose)
Recruitment status
unknown
Participants will receive JNJ-78934804 dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Group 5: JNJ-78934804 (Mid-dose)
Recruitment status
unknown
Participants will receive JNJ-78934804 dose regimen 2 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Group 6: JNJ-78934804 (Low-dose)
Recruitment status
unknown
Participants will receive JNJ-78934804 dose regimen 3 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Current data since :
April 23, 2024 20:00
Study's description
Study description
Study summary
The 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.
Locations
Locations
Main center
CENTRE INTÉGRÉ DE SANTÉ ET DE SERVICES SOCIAUX DES LAURENTIDES
