Guselkumab Dose 3 for Crohn's Disease

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Crohn's DiseaseGuselkumab Dose 3 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether the drug guselkumab is effective and safe for people with Crohn's disease.

Treatment Effectiveness

Effectiveness Progress

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

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Up to 109 Weeks

Up to 109 Weeks
Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation of Study Intervention
Week 12
Clinical Remission at Week 12
Clinical Response at Week 12
Endoscopic Response at Week 12
Patient-reported Outcome (PRO)-2 Remission at Week 12
Week 24
Clinical Remission at Week 24

Trial Safety

Safety Progress

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

Trial Design

3 Treatment Groups

Group 1: Guselkumab
1 of 3
Group 2: Guselkumab
1 of 3
Group 3: Placebo
1 of 3

Experimental Treatment

Non-Treatment Group

318 Total Participants · 3 Treatment Groups

Primary Treatment: Guselkumab Dose 3 · Has Placebo Group · Phase 3

Group 1: GuselkumabExperimental Group · 2 Interventions: Guselkumab Dose 2, Guselkumab Dose 1 · Intervention Types: Drug, Drug
Group 2: GuselkumabExperimental Group · 2 Interventions: Guselkumab Dose 1, Guselkumab Dose 3 · Intervention Types: Drug, Drug
Group 3: Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
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

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 109 weeks

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
924 Previous Clinical Trials
6,330,799 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
710 Previous Clinical Trials
3,903,784 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a diagnosis of Crohn's disease (CD) of at least 3 months in duration.
You have demonstrated intolerance or inadequate response to conventional or to biologic therapy for Crohn's disease.

Who else is applying?

What state do they live in?
North Carolina50.0%
Texas50.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria50.0%
Met criteria50.0%
How many prior treatments have patients received?
3+100.0%