Guselkumab Dose 1 for Colitis, Ulcerative
Phase-Based Progress Estimates
Effectiveness
Safety
CHRU Besançon -Hôpital Jean Minjoz, Besancon Cedex, France
Colitis, Ulcerative+2 More
Guselkumab Dose 1 - DrugEligibility
18+
All Sexes
What conditions do you have?
Select
Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).
Eligible Conditions
- Colitis, Ulcerative
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
0 Primary · 6 Secondary · Reporting Duration: Weeks 12 and 24
Up to Week 112
Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation of Study Intervention
Week 12
Histologic-Endoscopic Mucosal Improvement
Week 24
Clinical Remission
Weeks 12 and 24
Clinical Response
Endoscopic Improvement
Symptomatic Remission
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
3 Treatment Groups
Group 2: Guselkumab
1 of 3
Group 1: Guselkumab
1 of 3
Group 3: Placebo
1 of 3
Experimental Treatment
Non-Treatment Group
400 Total Participants · 3 Treatment Groups
Primary Treatment: Guselkumab Dose 1 · Has Placebo Group · Phase 3
Group 2: GuselkumabExperimental Group · 2 Interventions: Guselkumab Dose 1, Guselkumab Dose 3 · Intervention Types: Drug, Drug
Group 1: GuselkumabExperimental Group · 2 Interventions: Guselkumab Dose 2, Guselkumab Dose 1 · Intervention Types: Drug, Drug
Group 3: Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: OtherTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guselkumab Dose 2
2018
Completed Phase 2
~240
Guselkumab Dose 1
2018
Completed Phase 2
~240
Guselkumab Dose 3
2018
Completed Phase 1
~30
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: weeks 12 and 24
Closest Location: Northshore Gastroenterology Research, LLC · Westlake, OH
2021First Recorded Clinical Trial
3 TrialsResearching Colitis, Ulcerative
3 CompletedClinical Trials
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
916 Previous Clinical Trials
6,326,468 Total Patients Enrolled
16 Trials studying Colitis, Ulcerative
6,725 Patients Enrolled for Colitis, Ulcerative
Janssen Research & Development, LLC Clinical trialStudy DirectorJanssen Research & Development, LLC
6 Previous Clinical Trials
1,654 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 5 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have a documented diagnosis of ulcerative colitis (UC) at least 12 weeks prior to screening.
You have demonstrated inadequate response to or intolerance of conventional therapy and/or advanced therapy as defined in the protocol.
About The Reviewer
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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