Guselkumab Dose 1 for Colitis, Ulcerative

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
CHRU Besançon -Hôpital Jean Minjoz, Besancon Cedex, France
Colitis, Ulcerative+2 More
Guselkumab Dose 1 - Drug
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

2 of 3
This is further along than 85% of similar trials

Other trials for Colitis, Ulcerative

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

3 of 3
This is further along than 85% of similar trials

Other trials for Colitis, Ulcerative

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: Other
Treatment
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
Photo of ohio 1Photo of ohio 2Photo of ohio 3
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 preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 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.