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A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis

Phase 2
Active, not recruiting
Conditions
Ulcerative Colitis
Interventions
Drug: Placebo
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
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Induction Study 1: Placebo IVPlaceboParticipants 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 IVPlaceboParticipants 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 SCPlaceboParticipants will receive matching placebo SC q4w.
Induction Study 1: Guselkumab Dose 1GuselkumabParticipants 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 2GuselkumabParticipants 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 IVGuselkumabParticipants 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 1GuselkumabParticipants will receive guselkumab maintenance dose regimen 1 subcutaneously (SC) every 4 weeks (q4w).
Maintenance Study: Maintenance Dose Regimen 2GuselkumabParticipants will receive guselkumab maintenance dose regimen 2 SC every 8 weeks (q8w).
Primary Outcome Measures
NameTimeMethod
Induction Study 1: Percentage of Participants With Clinical Response at Week I-12At 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-12At 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-44At 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
NameTimeMethod
Induction Study 1: Percentage of Participants With Clinical Remission at Week I-12At Week I-12
Induction Study 1: Percentage of Participants With Symptomatic Remission at Week I-12At Week I-12
Induction Study 1: Percentage of Participants With Endoscopic Healing at Week I-12At Week I-12
Induction Study 1: Percentage of Participants With Histologic-Endoscopic Mucosal Healing at Week I-12At Week I-12
Induction Study 1: Percentage of Participants With Endoscopic Normalization at Week I-12At Week I-12
Induction Study 2: Percentage of Participants With Symptomatic Remission at Week I-12At Week I-12
Induction Study 2: Percentage of Participants With Endoscopic Healing at Week I-12At Week I-12
Induction Study 2: Percentage of Participants With Clinical Response at Week I-12At Week I-12
Induction Study 2: Percentage of Participants With Symptomatic Remission at Week I-4At Week I-4
Induction Study 2: Percentage of Participants With Fatigue Response at Week I-12At Week I-12
Induction Study 2: Percentage of Participants With Symptomatic Remission at Week I-2At Week I-2
Induction Study 2: Percentage of Participants With Endoscopic Normalization at Week I-12At Week I-12
Maintenance Study: Percentage of Participants With Symptomatic Remission at Week M-44At Week M-44
Maintenance Study: Percentage of Participants With Endoscopic Healing at Week M-44At Week M-44
Maintenance Study: Percentage of Participants With Corticosteroid-free Clinical Remission at Week M-44At Week M-44
Maintenance Study: Percentage of Participants With Clinical Response at Week M-44At Week M-44
Maintenance Study: Percentage of Participants With Histologic-Endoscopic Mucosal Healing at Week M-44At Week M-44
Maintenance Study: Percentage of Participants With IBDQ Remission at Week M-44At Week M-44
Maintenance Study: Percentage of Participants With Fatigue Response at Week M-44At Week M-44
Maintenance Study: Percentage of Participants With Clinical Remission at Week 44 Among the Participants Who Had Achieved Clinical Remission at Maintenance BaselineAt Week M-44
Maintenance Study: Percentage of Participants With Endoscopic Normalization at Week M-44At Week M-44
Induction Study 2: Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week I-12At Week I-12
Induction Study 2: Percentage of Participants With Histologic-Endoscopic Mucosal Healing at Week I-12At 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

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