A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
- Registration Number
- NCT04033445
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1064
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Induction Study 1: Placebo IV Placebo 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. Induction Study 2: Placebo IV Placebo 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. Maintenance Study: Placebo SC Placebo Participants will receive matching placebo SC q4w. Induction Study 1: Guselkumab Dose 1 Guselkumab 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. Induction Study 1: Guselkumab Dose 2 Guselkumab 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. Induction Study 2: Guselkumab IV Guselkumab 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. Maintenance Study: Maintenance Dose Regimen 1 Guselkumab Participants will receive guselkumab maintenance dose regimen 1 subcutaneously (SC) every 4 weeks (q4w). Maintenance Study: Maintenance Dose Regimen 2 Guselkumab Participants will receive guselkumab maintenance dose regimen 2 SC every 8 weeks (q8w).
- Primary Outcome Measures
Name Time Method Induction Study 1: Percentage of Participants With Clinical Response at Week I-12 At Week I-12 Clinical response was defined as a decrease from induction baseline in the modified Mayo score by greater than or equal to (\>=) 30 percent (%) and \>=2 points, with either a \>=1 point decrease from baseline (Week 0 of IS-1) in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. This outcome measure was planned to be analyzed for specified arms only.
Induction Study 2: Percentage of Participants With Clinical Remission at Week I-12 At Week I-12 Clinical remission was based on the modified Mayo score. Clinical remission was defined as Mayo stool frequency subscore of 0 or 1 and not increased from baseline (Week 0 of IS-2), a Mayo rectal bleeding subscore of 0, and Mayo endoscopic subscore of 0 or 1 with no friability. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. This outcome measure was planned to be analyzed for specified arms only.
Maintenance Study: Percentage of Participants With Clinical Remission at Week M-44 At Week M-44 Clinical remission was based on the modified Mayo score. Clinical remission was defined as Mayo stool frequency subscore of 0 or 1 and not increased from baseline (Week 0 of IS-1 and IS-2), a Mayo rectal bleeding subscore of 0, and Mayo endoscopic subscore of 0 or 1 with no friability. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. This outcome measure was planned to be analyzed for randomized arms only.
- Secondary Outcome Measures
Name Time Method Induction Study 1: Percentage of Participants With Clinical Remission at Week I-12 At Week I-12 Induction Study 1: Percentage of Participants With Symptomatic Remission at Week I-12 At Week I-12 Induction Study 1: Percentage of Participants With Endoscopic Healing at Week I-12 At Week I-12 Induction Study 1: Percentage of Participants With Histologic-Endoscopic Mucosal Healing at Week I-12 At Week I-12 Induction Study 1: Percentage of Participants With Endoscopic Normalization at Week I-12 At Week I-12 Induction Study 2: Percentage of Participants With Symptomatic Remission at Week I-12 At Week I-12 Induction Study 2: Percentage of Participants With Endoscopic Healing at Week I-12 At Week I-12 Induction Study 2: Percentage of Participants With Clinical Response at Week I-12 At Week I-12 Induction Study 2: Percentage of Participants With Symptomatic Remission at Week I-4 At Week I-4 Induction Study 2: Percentage of Participants With Fatigue Response at Week I-12 At Week I-12 Induction Study 2: Percentage of Participants With Symptomatic Remission at Week I-2 At Week I-2 Induction Study 2: Percentage of Participants With Endoscopic Normalization at Week I-12 At Week I-12 Maintenance Study: Percentage of Participants With Symptomatic Remission at Week M-44 At Week M-44 Maintenance Study: Percentage of Participants With Endoscopic Healing at Week M-44 At Week M-44 Maintenance Study: Percentage of Participants With Corticosteroid-free Clinical Remission at Week M-44 At Week M-44 Maintenance Study: Percentage of Participants With Clinical Response at Week M-44 At Week M-44 Maintenance Study: Percentage of Participants With Histologic-Endoscopic Mucosal Healing at Week M-44 At Week M-44 Maintenance Study: Percentage of Participants With IBDQ Remission at Week M-44 At Week M-44 Maintenance Study: Percentage of Participants With Fatigue Response at Week M-44 At Week M-44 Maintenance Study: Percentage of Participants With Clinical Remission at Week 44 Among the Participants Who Had Achieved Clinical Remission at Maintenance Baseline At Week M-44 Maintenance Study: Percentage of Participants With Endoscopic Normalization at Week M-44 At Week M-44 Induction Study 2: Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week I-12 At Week I-12 Induction Study 2: Percentage of Participants With Histologic-Endoscopic Mucosal Healing at Week I-12 At Week I-12
Trial Locations
- Locations (384)
Om Research LLC
🇺🇸Lancaster, California, United States
UCLA
🇺🇸Los Angeles, California, United States
Peak Gastroenterology Associates
🇺🇸Colorado Springs, Colorado, United States
Florida Research Network, LLC
🇺🇸Gainesville, Florida, United States
University of Florida Health Jacksonville
🇺🇸Gainesville, Florida, United States
Harmony Medical Research Institute, Inc.
🇺🇸Hialeah, Florida, United States
UF Health Jacksonville Gastroenterology Emerson
🇺🇸Jacksonville, Florida, United States
I.H.S. Health. LLC
🇺🇸Kissimmee, Florida, United States
Columbus Clinical Services LLC
🇺🇸Miami, Florida, United States
Vista Health Research, LLC
🇺🇸Miami, Florida, United States
Scroll for more (374 remaining)Om Research LLC🇺🇸Lancaster, California, United States