Your session is about to expire
← Back to Search
Monoclonal Antibodies
Guselkumab for Crohn's Disease (REASON Trial)
Phase 3
Recruiting
Research Sponsored by Janssen-Cilag Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has luminal Crohn's disease (CD) of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
Has clinically active CD, defined as a baseline CD activity index (CDAI) score greater than or equal to (>=)220 but <=450 and either: a. Mean daily stool frequency (SF) count >=4, based on the unweighted CDAI component of the number of liquid or very soft stools or b. Mean daily AP score >=2, based on the unweighted CDAI component of abdominal pain (AP)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 4, 8, 16, 32, 48, and 96
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial aims to see if guselkumab can help heal all layers of the digestive tract by using a score called Magnetic Resonance Index of Activity (MaRIA) in a scan
Who is the study for?
This trial is for individuals with Crohn's disease of at least 3 months, showing active symptoms and poor response or intolerance to certain therapies. Participants must have a specific level of disease activity measured by stool frequency or abdominal pain and confirmed transmural activity in the digestive tract.
What is being tested?
The study tests Guselkumab's ability to heal all layers of the digestive tract in Crohn's patients. Effectiveness will be measured using a special MRI-based score (MaRIA) at Week 48 to assess transmural healing.
What are the potential side effects?
While not specified here, Guselkumab may cause side effects similar to other medications used for Crohn’s Disease such as infections, allergic reactions, injection site reactions, headache, fatigue, and gastrointestinal symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had Crohn's disease affecting my colon or small intestine for at least 3 months.
Select...
My Crohn's disease is active, with significant symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, weeks 4, 8, 16, 32, 48, and 96
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 4, 8, 16, 32, 48, and 96
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants Achieving a Magnetic Resonance Index of Activity (MaRIA) Less Than (<)11 in All Intestinal Segments at Week 48
Secondary study objectives
Absolute Value of BWT through Week 96
Absolute Value of CDAI Score Through Week 96
Absolute Value of Global Simple MaRIA Score Through Week 96
+44 moreSide effects data
From 2020 Phase 4 trial • 1027 Patients • NCT035733231%
Nasopharyngitis
1%
Upper respiratory tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ixekizumab Post-Treatment Follow Up
Ixekizumab
Guselkumab
Guselkumab Post-Treatment Follow Up
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: GuselkumabExperimental Treatment1 Intervention
Participants will receive guselkumab 200 milligram (mg) intravenously (IV) at week 0, 4 and 8. Afterwards, participants will be alternately assigned at study level to 2 dose cohorts, high dose (200 mg subcutaneous (SC) every 4 weeks (Q4W) starting at week 12) through week 92 or low dose (100 mg SC every 8 weeks (Q8W) starting at week 16) through week 88. Starting at Week 24, participants in the low-dose cohort will be permitted to escalate to the 200 mg SC Q4W regimen if they are symptomatic and at the discretion of the investigator.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guselkumab
2015
Completed Phase 4
~6080
Find a Location
Who is running the clinical trial?
Janssen-Cilag Ltd.Lead Sponsor
99 Previous Clinical Trials
48,744 Total Patients Enrolled
Janssen Cilag Ltd. Clinical trialStudy DirectorJanssen-Cilag Ltd.