A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
Purpose
The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).
Condition
- Ulcerative Colitis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Documented diagnosis of ulcerative colitis (UC) - Moderately to severely active UC, defined by modified Mayo score - Demonstrated inadequate response or intolerance to medical therapies specified in the protocol - Screening laboratory test results within the parameters specified in the protocol
Exclusion Criteria
- Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease or clinical findings suggestive of Crohn's disease - UC limited to the rectum only or to less than (<) 20 centimeter (cm) of the colon - Presence of a stoma - Presence or history of a fistula - Receiving prohibited medications and/or treatment
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Induction Study 1: Guselkumab Dose 1 |
Participants will receive guselkumab dose 1 intravenously (IV) in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12. |
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|
Experimental Induction Study 1: Guselkumab Dose 2 |
Participants will receive guselkumab dose 2 IV in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12. |
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|
Placebo Comparator Induction Study 1: Placebo IV |
Participants will receive matching placebo IV in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12. Clinical nonresponders will be administered guselkumab IV. |
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|
Experimental Induction Study 2: Guselkumab IV |
Participants will receive guselkumab IV in Induction Study 2. Subsequent study treatment will be determined by the participant's clinical response status at Week 12. |
|
|
Placebo Comparator Induction Study 2: Placebo IV |
Participants will receive matching placebo IV in Induction Study 2. Subsequent study treatment will be determined by the participant's clinical response status at Week 12. Clinical nonresponders will be administered guselkumab IV. |
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|
Experimental Maintenance Study: Maintenance Dose Regimen 1 |
Participants will receive guselkumab maintenance dose regimen 1 subcutaneously (SC) every 4 weeks (q4w). |
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Experimental Maintenance Study: Maintenance Dose Regimen 2 |
Participants will receive guselkumab maintenance dose regimen 2 SC every 8 weeks (q8w). |
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|
Placebo Comparator Maintenance Study: Placebo SC |
Participants will receive matching placebo SC q4w. |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Janssen Research & Development, LLC
Study Contact
Detailed Description
UC is a chronic disease of the large intestine, in which the lining of the colon becomes inflamed and develops ulcers. Guselkumab is a fully human immunoglobulin G1 lambda monoclonal antibody (mAb) that binds to human interleukin (IL)-23 with high affinity. The study is designed to answer scientific questions pertaining to the efficacy and safety of guselkumab in the treatment of moderately to severely active UC. Overall, the study will evaluate long-term guselkumab treatment. Efficacy, safety, pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points.