Study Summary
This trial will test if guselkumab is an effective and safe treatment for people with moderate to severe ulcerative colitis.
Eligible Conditions
- Ulcerative Colitis
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 23 Secondary · Reporting Duration: Week 44
Week 12
Induction Study 1: Clinical Remission at Week 12
Induction Study 1: Clinical Response at Week 12
Induction Study 1: Endoscopic Healing at Week 12
Induction Study 1: Endoscopic Normalization at Week 12
Induction Study 1: Histo-Endoscopic Mucosal Healing at Week 12
Induction Study 1: Symptomatic Remission at Week 12
Induction Study 2: Clinical Remission at Week 12
Induction Study 2: Clinical Response at Week 12
Induction Study 2: Endoscopic Healing at Week 12
Induction Study 2: Endoscopic Normalization at Week 12
Induction Study 2: Fatigue Response at Week 12
Induction Study 2: Histo-Endoscopic Mucosal Healing at Week 12
Induction Study 2: Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 12
Induction Study 2: Symptomatic Remission at Week 12
Week 2
Induction Study 2: Symptomatic Remission at Week 2
Week 4
Induction Study 2: Symptomatic Remission at Week 4
Week 44
Maintenance Study: Clinical Remission at Week 44
Maintenance Study: Clinical Remission at Week 44 Among the Participants Who had Achieved Clinical Remission at Maintenance Baseline
Maintenance Study: Clinical Response at Week 44
Maintenance Study: Corticosteroid-free Clinical Remission at Week 44
Maintenance Study: Endoscopic Healing at Week 44
Maintenance Study: Endoscopic Normalization at Week 44
Maintenance Study: Fatigue Response at Week 44
Maintenance Study: Histo-Endoscopic Mucosal Healing at Week 44
Maintenance Study: IBDQ Remission at Week 44
Maintenance Study: Symptomatic Remission at Week 44
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
Ixekizumab
9%Injection site reaction
8%Upper respiratory tract infection
7%Nasopharyngitis
Trial Design
8 Treatment Groups
Induction Study 2: Guselkumab IV
1 of 8
Induction Study 1: Guselkumab Dose 1
1 of 8
Induction Study 1: Guselkumab Dose 2
1 of 8
Maintenance Study: Maintenance Dose Regimen 1
1 of 8
Maintenance Study: Maintenance Dose Regimen 2
1 of 8
Induction Study 2: Placebo IV
1 of 8
Induction Study 1: Placebo IV
1 of 8
Maintenance Study: Placebo SC
1 of 8
Experimental Treatment
Non-Treatment Group
1064 Total Participants · 8 Treatment Groups
Primary Treatment: Guselkumab · Has Placebo Group · Phase 2 & 3
Induction Study 2: Guselkumab IV
Drug
Experimental Group · 1 Intervention: Guselkumab · Intervention Types: DrugInduction Study 1: Guselkumab Dose 1
Drug
Experimental Group · 1 Intervention: Guselkumab · Intervention Types: DrugInduction Study 1: Guselkumab Dose 2
Drug
Experimental Group · 1 Intervention: Guselkumab · Intervention Types: DrugMaintenance Study: Maintenance Dose Regimen 1
Drug
Experimental Group · 1 Intervention: Guselkumab · Intervention Types: DrugMaintenance Study: Maintenance Dose Regimen 2
Drug
Experimental Group · 1 Intervention: Guselkumab · Intervention Types: DrugInduction Study 2: Placebo IV
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugInduction Study 1: Placebo IV
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugMaintenance Study: Placebo SC
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guselkumab
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 44
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
918 Previous Clinical Trials
6,325,821 Total Patients Enrolled
2 Trials studying Ulcerative Colitis
562 Patients Enrolled for Ulcerative Colitis
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
707 Previous Clinical Trials
3,898,799 Total Patients Enrolled
2 Trials studying Ulcerative Colitis
562 Patients Enrolled for Ulcerative Colitis
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have inadequate response or intolerance to medical therapies specified in the protocol.
About The Reviewer
Michael Gill - B. Sc.
First Published: October 6th, 2021
Last Reviewed: November 6th, 2022
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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Conditions
Cancer Related
Treatments