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Janus Kinase (JAK) Inhibitor

Filgotinib for Crohn's Disease (DIVERSITYLTE Trial)

Phase 3

Waitlist Available

Research Sponsored by Galapagos NV

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 390 weeks plus 30 days

Awards & highlights

DIVERSITYLTE Trial Summary

This trial is observing the long-term effects of a drug called filgotinib in people with Crohn's Disease.

Eligible Conditions

Crohn's Disease

DIVERSITYLTE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 390 weeks plus 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 390 weeks plus 30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 390 weeks plus 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Safety Profile of Filgotinib Evaluated by the Percentage of Participants Experiencing Adverse Events and Abnormal Clinical Laboratory Tests

Secondary outcome measures

Change from Baseline in Crohn's Disease Activity Index (CDAI) Scores

Change from Baseline in PRO2 Scores

Side effects data

From 2018 Phase 3 trial • 449 Patients • NCT02873936

Nasopharyngitis

Headache

Upper respiratory tract infection

Nausea

Bronchitis

Osteitis

Lumbar spinal stenosis

Abscess oral

Rheumatoid arthritis

Gallbladder empyema

Depression

Myocardial ischaemia

Anaemia

Vulval abscess

100%

80%

60%

40%

20%

Study treatment Arm

Filgotinib 100 mg

Placebo

Filgotinib 200 mg

DIVERSITYLTE Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Filgotinib 200 mg (open-label)Experimental Treatment1 Intervention

Filgotinib 200 mg for up to 390 weeks

Group II: Filgotinib 200 mg (blinded dosing)Experimental Treatment2 Interventions

Filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 390 weeks

Group III: Filgotinib 100 mg (open-label)Experimental Treatment1 Intervention

Filgotinib 100 mg for up to 390 weeks

Group IV: Filgotinib 100 mg (blinded dosing)Experimental Treatment2 Interventions

Filgotinib 100 mg + placebo to match filgotinib 200 mg for up to 390 weeks

Group V: Placebo (blinded dosing)Placebo Group1 Intervention

Placebo to match filgotinib 200 mg for up to 390 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Filgotinib

2017

Completed Phase 3

~7520

Placebo

1995

Completed Phase 3

~2670

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Galapagos NVLead Sponsor

137 Previous Clinical Trials

21,735 Total Patients Enrolled

Gilead SciencesIndustry Sponsor

1,082 Previous Clinical Trials

841,511 Total Patients Enrolled

Gilead Study DirectorStudy DirectorGilead Sciences

343 Previous Clinical Trials

185,505 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you explain the severity of potential side effects for those taking Filgotinib?

"Our analysts have reason to believe that Filgotinib is safe due to the fact that this is a Phase 3 trial. Efficacy has been supported by some data and there have been multiple rounds of research to support safety."

Answered by AI

Could you please tell me how many different places are coordinating this trial?

"There are 100 locations running this clinical trial, such as DHAT Research Institute in Garland, Florida Research Institute in Lakewood Ranch, and Options Health Research LLC in Tulsa."

Answered by AI

Are there any vacancies for this study?

"No, this study is no longer recruiting patients. The trial was originally posted on March 17th, 2017 and was last edited on April 20th, 2022. If you are interested in other studies, there are presently 256 studies actively looking for participants with ileocolitis and 9 trials for Filgotinib actively admitting participants."

Answered by AI

Have other researchers done anything similar to this before?

"Filgotinib has 9 active trials in 202 cities and 50 countries. The first trial was in 2014 and it completed Phase 2 in 739 patients. 18254 studies have been completed since then."

Answered by AI

Are there any other published research on Filgotinib?

"Filgotinib was first trialed in 2014 at the Clinica de Especialidades Medicas. A total of 18,254 completed trials have been conducted since then, with 9 more currently underway. The majority of these live trials are taking place in Garland, Texas."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease

2017. "Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02914600.