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Janus Kinase (JAK) Inhibitor
Long-Term Filgotinib for Ulcerative Colitis (SELECTIONLTE 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
Females of childbearing potential must have a negative pregnancy test at Day 1
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 336 weeks plus 30 days
Awards & highlights
SELECTIONLTE Trial Summary
This trial is looking at the long-term safety of a drug called filgotinib in people with ulcerative colitis who have completed or met certain efficacy criteria in a previous study.
Who is the study for?
This trial is for adults who've previously been in a filgotinib study for ulcerative colitis. They must agree to use contraception if of childbearing potential, avoid certain vaccines, and have the ability to understand and sign consent forms. Those with known drug hypersensitivity or chronic conditions that could interfere with the study are excluded.Check my eligibility
What is being tested?
The trial is observing long-term safety of filgotinib, an investigational drug for ulcerative colitis. Participants will either continue using filgotinib or receive a placebo based on prior participation in related studies.See study design
What are the potential side effects?
While not specified here, common side effects of drugs like filgotinib may include nausea, headache, fatigue, and possible increased risk of infection due to immune system effects.
SELECTIONLTE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am of childbearing age and my pregnancy test was negative.
SELECTIONLTE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 336 weeks plus 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 336 weeks plus 30 days
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 Proportion of Participants Experiencing Adverse Events and Abnormal Clinical Laboratory Tests
Secondary outcome measures
Change From Baseline in Components of Mayo Clinic Score (MCS)
Side effects data
From 2018 Phase 3 trial • 449 Patients • NCT028739366%
Nasopharyngitis
6%
Headache
6%
Upper respiratory tract infection
5%
Nausea
2%
Bronchitis
1%
Lumbar spinal stenosis
1%
Abscess oral
1%
Osteitis
1%
Rheumatoid arthritis
1%
Gallbladder empyema
1%
Depression
1%
Myocardial ischaemia
1%
Anaemia
1%
Vulval abscess
100%
80%
60%
40%
20%
0%
Study treatment Arm
Filgotinib 100 mg
Placebo
Filgotinib 200 mg
SELECTIONLTE Trial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: Filgotinib 200 mg (open-label)Experimental Treatment1 Intervention
Filgotinib 200 mg for up to 336 weeks
Group II: Filgotinib 200 mg (blinded dosing)Experimental Treatment2 Interventions
Filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks
Group III: Filgotinib 100 mg (open-label)Experimental Treatment1 Intervention
Filgotinib 100 mg for up to 336 weeks
Group IV: Filgotinib 100 mg (blinded dosing)Experimental Treatment2 Interventions
Filgotinib 100 mg + placebo to match filgotinib 200 mg for up to 336 weeks
Group V: Placebo (blinded dosing)Placebo Group1 Intervention
Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 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
Find a Location
Who is running the clinical trial?
Galapagos NVLead Sponsor
137 Previous Clinical Trials
21,750 Total Patients Enrolled
7 Trials studying Ulcerative Colitis
2,133 Patients Enrolled for Ulcerative Colitis
Gilead SciencesIndustry Sponsor
1,082 Previous Clinical Trials
841,668 Total Patients Enrolled
7 Trials studying Ulcerative Colitis
2,236 Patients Enrolled for Ulcerative Colitis
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
185,662 Total Patients Enrolled
6 Trials studying Ulcerative Colitis
2,208 Patients Enrolled for Ulcerative Colitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am of childbearing age and my pregnancy test was negative.I am not willing to follow the study's birth control requirements.I agree to use the specified birth control methods if I can have children.I agree to use birth control as specified by the study.I agree not to get any live vaccines during and for 3 months after the study.
Research Study Groups:
This trial has the following groups:- Group 1: Filgotinib 200 mg (blinded dosing)
- Group 2: Filgotinib 100 mg (blinded dosing)
- Group 3: Placebo (blinded dosing)
- Group 4: Filgotinib 200 mg (open-label)
- Group 5: Filgotinib 100 mg (open-label)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are some possible Filgotinib dangers that patients should be aware of?
"While this is only a Phase 3 trial, there is already some data supporting Filgotinib's efficacy and multiple rounds of data affirming its safety; we feel comfortable giving it a 3."
Answered by AI
Will this clinical trial be breaking new ground?
"Research into filgotinib began in 2014 with an initial clinical trial that was sponsored by Galapagos NV. 739 patients participated in the first study. After Phase 2 approval was received, 9 clinical trials involving filgotinib are now ongoing in 202 cities and 50 countries."
Answered by AI
How many people are currently signed up to test this new medication?
"This trial is now closed to patients. It was first made public on February 23rd, 2017 and was last updated on December 21st, 2021. At the moment, there are 425 clinical trials actively seeking patients with colitis and 9 studies for Filgotinib admitting patients."
Answered by AI
Are there multiple research centers conducting this trial within the United States?
"Currently, this clinical trial is being administered at 62 different sites, which are located in cities such as Nashville, Annapolis and Troy. To limit travel if you enroll, it is best to select a location that is nearest to you."
Answered by AI
What other Filgotinib research studies have taken place?
"Filgotinib was first evaluated in 2014 at Clinica de Especialidades Medicas. A total of 18280 clinical trials have completed since the medication's inception. Currently, 9 studies are ongoing with a majority of test subjects coming from Nashville, Tennessee."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
Texas
How old are they?
18 - 65
What site did they apply to?
Carolina's GI Research LLC
TDDC San Marcos
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
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