2023-504743-13-00
Active, not recruiting
Phase 2
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
Janssen - Cilag International128 sites in 12 countries383 target enrollmentStarted: May 22, 2024Last updated:
Overview
- Phase
- Phase 2
- Status
- Active, not recruiting
- Enrollment
- 383
- Locations
- 128
- Primary Endpoint
- Clinical remission at Week 48 compared with each monotherapy
Overview
Brief Summary
To evaluate the efficacy of JNJ-78934804 at Week 48 compared with each monotherapy (guselkumab alone and golimumab alone)
Eligibility Criteria
- Ages
- 18 years to 64 years (18-64 Years)
- Accepts Healthy Volunteers
- No
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 advanced therapy (ADT) for IBD that includes biologics as well as oral small molecule therapies with biologic-like effects
- •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
- •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)
Outcomes
Primary Outcomes
Clinical remission at Week 48 compared with each monotherapy
Clinical remission at Week 48 compared with each monotherapy
Secondary Outcomes
No secondary outcomes reported
Investigators
Clinical Registry Groupp
Scientific
Janssen - Cilag International
Study Sites (128)
Loading locations...
Similar Trials
Active, not recruiting
Phase 3
A Phase 3 Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Ulcerative Colitis2023-504719-34-00Janssen - Cilag International143
Recruiting
Phase 3
Study to Evaluate the Efficacy, Pharmacokinetics, Safety, and Immunogenicity of Subcutaneously Administered Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis2023-507144-36-00Janssen - Cilag International30
Active, not recruiting
Phase 3
A Study of Efficacy, Safety, and Pharmacokinetics of Guselkumab in the Treatment of Chronic Plaque Psoriasis in Pediatric Participants2023-503378-19-00Janssen - Cilag International97
Active, not recruiting
Phase 3
GRAVITI - A Phase 3 Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Crohn's Disease2023-504737-41-00Janssen - Cilag International219
Active, not recruiting
Phase 2
An Open Label Study of JNJ-68284528, Directed Against BCMA in Subjects with Multiple Myeloma2023-506587-13-00Janssen - Cilag International56