Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
This trial is testing a new drug for Crohn's disease in both people who have never taken a biologic drug and people who have. The goal is to see if it is safe and effective. People who finish the study or don't respond well can enter a long-term extension study.
Eligible Conditions
- Crohn Disease
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
4 Primary · 10 Secondary · Reporting Duration: Week 26 (predose or postdose) and Week 58 predose
Week 10
Induction Study: Proportion of Participants Achieving Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10
Induction Study: Proportion of Participants Achieving Clinical Remission by Patient Reported Outcomes (PRO2) at Week 10
Induction Study: Proportion of Participants Achieving Clinical Response by CDAI at Week 10
Induction Study: Proportion of Participants Achieving Endoscopic Response at Week 10
Week 58
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib and its Metabolite GS-829845
Week 10
Induction Study: Pharmacokinetic Concentrations of Filgotinib and its Metabolite GS-829845
Week 58
Adrenal Cortex Hormones
Maintenance Study: Proportion of Participants Achieving 6 Month Corticosteroid-Free Remission by PRO2 at Week 58
Maintenance Study: Proportion of Participants Achieving Clinical Remission by CDAI at Week 58
Maintenance Study: Proportion of Participants Achieving Clinical Remission by PRO2 at Week 58
Maintenance Study: Proportion of Participants Achieving Clinical Response by CDAI at Week 58
Maintenance Study: Proportion of Participants Achieving Endoscopic Response at Week 58
Maintenance Study: Proportion of Participants Achieving Sustained Clinical Remission by CDAI
Maintenance Study: Proportion of Participants Achieving Sustained Clinical Remission by PRO2
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Side Effects for
Filgotinib 100 mg
6%Nasopharyngitis
6%Headache
6%Upper respiratory tract infection
5%Nausea
2%Bronchitis
1%Rheumatoid arthritis
1%Anaemia
1%Abscess oral
1%Gallbladder empyema
1%Depression
1%Lumbar spinal stenosis
1%Osteitis
1%Vulval abscess
1%Myocardial ischaemia
Trial Design
4 Treatment Groups
Maintenance Study
1 of 4
Filgotinib 100 mg (Induction Study)
1 of 4
Filgotinib 200 mg (Induction Study)
1 of 4
Placebo (Induction Study)
1 of 4
Experimental Treatment
Non-Treatment Group
1374 Total Participants · 4 Treatment Groups
Primary Treatment: Filgotinib · Has Placebo Group · Phase 3
Maintenance StudyExperimental Group · 2 Interventions: Placebo to match filgotinib, Filgotinib · Intervention Types: Drug, Drug
Filgotinib 100 mg (Induction Study)Experimental Group · 2 Interventions: Placebo to match filgotinib, Filgotinib · Intervention Types: Drug, Drug
Filgotinib 200 mg (Induction Study)Experimental Group · 2 Interventions: Placebo to match filgotinib, Filgotinib · Intervention Types: Drug, Drug
Placebo (Induction Study)
Drug
PlaceboComparator Group · 1 Intervention: Placebo to match filgotinib · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo to match filgotinib
2016
Completed Phase 3
~3600
Filgotinib
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 26 (predose or postdose) and week 58 predose
Who is running the clinical trial?
Galapagos NVLead Sponsor
128 Previous Clinical Trials
19,981 Total Patients Enrolled
4 Trials studying Crohn Disease
1,310 Patients Enrolled for Crohn Disease
Gilead SciencesIndustry Sponsor
1,006 Previous Clinical Trials
651,995 Total Patients Enrolled
5 Trials studying Crohn Disease
1,562 Patients Enrolled for Crohn Disease
Gilead Study DirectorStudy DirectorGilead Sciences
316 Previous Clinical Trials
177,591 Total Patients Enrolled
3 Trials studying Crohn Disease
1,135 Patients Enrolled for Crohn Disease
Galapagos Study DirectorStudy DirectorGalapagos NV
14 Previous Clinical Trials
10,175 Total Patients Enrolled
1 Trials studying Crohn Disease
1,000 Patients Enrolled for Crohn Disease
Eligibility Criteria
Age 18+ · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a documented diagnosis of CD with a minimum disease duration of 3 months with involvement of the ileum and/or colon at a minimum, as determined by histopathology and endoscopic assessment.
You have had an inadequate response to, or loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines): corticosteroids and immunomodulators.
About The Reviewer
Michael Gill - B. Sc.
First Published: October 31st, 2021
Last Reviewed: November 21st, 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.
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