Filgotinib for Ulcerative Colitis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Gastroenterology Group of Naples, Naples, FL
Ulcerative Colitis+3 More
Filgotinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

Participants who are in clinical remission on 200 mg filgotinib once daily (q.d.) for at least 2 consecutive quarterly visits in the ongoing SELECTION-LTE study (GS-US-418-3899, NCT02914535), are planned to be rolled over and randomized in this study. The primary objective of this study is to evaluate the efficacy of filgotinib in participants in stable clinical remission on 200 mg filgotinib q.d. for whom the dose was decreased to 100 mg q.d. compared to participants remaining on 200 mg q.d.

Eligible Conditions

  • Ulcerative Colitis

Treatment Effectiveness

Effectiveness Progress

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

Other trials for Ulcerative Colitis

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Baseline (Day 1) up to 216 weeks

Week 216
Time to ES-Confirmed UC Flare
Time to Patient-Reported Outcome Based on 2 Items (PRO2) Flare
Week 216
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events, and TEAEs Leading to Treatment Discontinuation
Baseline, Week 48
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 48
Week 48
Change From Baseline in C-Reactive Protein (CRP) up to Week 48
Change From Baseline in Fecal Calprotectin (FCP) up to Week 48
Week 48
Percentage of Participants in Corticosteroid-free Clinical Remission Based on Modified Mayo Clinical Score (mMCS) at Week 48

Trial Safety

Safety Progress

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

Other trials for Ulcerative Colitis

Trial Design

2 Treatment Groups

Filgotinib 200 mg
1 of 2
Filgotinib 100 mg
1 of 2
Experimental Treatment

80 Total Participants · 2 Treatment Groups

Primary Treatment: Filgotinib · Has Placebo Group · Phase 3

Filgotinib 200 mgExperimental Group · 2 Interventions: Placebo, Filgotinib · Intervention Types: Drug, Drug
Filgotinib 100 mgExperimental Group · 2 Interventions: Placebo, Filgotinib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Filgotinib
2017
Completed Phase 3
~5290

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (day 1) up to 216 weeks
Closest Location: Gastroenterology Group of Naples · Naples, FL
2009First Recorded Clinical Trial
16 TrialsResearching Ulcerative Colitis
36 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are free of corticosteroids for at least 12 weeks prior to and including baseline.
You are a male participant aged 18 years or older or a female participant aged 18 years or older of childbearing potential.
The screening colonoscopy is a low-risk procedure

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.