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

ArmDescriptionAssigned 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.
  • Drug: Guselkumab
    Participants will receive guselkumab IV or SC.
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.
  • Drug: Guselkumab
    Participants will receive guselkumab IV or SC.
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.
  • Drug: Placebo
    Participants will receive matching placebo IV or SC.
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.
  • Drug: Guselkumab
    Participants will receive guselkumab IV or SC.
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.
  • Drug: Placebo
    Participants will receive matching placebo IV or SC.
Experimental
Maintenance Study: Maintenance Dose Regimen 1
Participants will receive guselkumab maintenance dose regimen 1 subcutaneously (SC) every 4 weeks (q4w).
  • Drug: Guselkumab
    Participants will receive guselkumab IV or SC.
Experimental
Maintenance Study: Maintenance Dose Regimen 2
Participants will receive guselkumab maintenance dose regimen 2 SC every 8 weeks (q8w).
  • Drug: Guselkumab
    Participants will receive guselkumab IV or SC.
Placebo Comparator
Maintenance Study: Placebo SC
Participants will receive matching placebo SC q4w.
  • Drug: Placebo
    Participants will receive matching placebo IV or SC.

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37212

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

Study Contact
844-434-4210
JNJ.CT@sylogent.com

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.