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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 below
Select...
I am of childbearing age and my pregnancy test was negative.

SELECTIONLTE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 336 weeks plus 30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 336 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 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 • NCT02873936
6%
Nasopharyngitis
6%
Headache
6%
Upper respiratory tract infection
5%
Nausea
2%
Bronchitis
1%
Abscess oral
1%
Rheumatoid arthritis
1%
Lumbar spinal stenosis
1%
Osteitis
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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Ulcerative Colitis (UC) include aminosalicylates, corticosteroids, immunomodulators, biologics, and Janus kinase (JAK) inhibitors like Filgotinib. Aminosalicylates reduce inflammation in the colon by inhibiting the production of inflammatory chemicals. Corticosteroids suppress the immune system to decrease inflammation rapidly. Immunomodulators, such as azathioprine, alter the immune response to prevent chronic inflammation. Biologics, including anti-TNF agents, target specific proteins involved in the inflammatory process. JAK inhibitors, like Filgotinib, block the activity of Janus kinase enzymes, which are involved in the signaling pathways that lead to inflammation. These treatments are crucial for UC patients as they help manage symptoms, induce and maintain remission, and improve the quality of life by controlling the underlying inflammation.

Find a Location

Who is running the clinical trial?

Galapagos NVLead Sponsor
137 Previous Clinical Trials
21,578 Total Patients Enrolled
7 Trials studying Ulcerative Colitis
2,133 Patients Enrolled for Ulcerative Colitis
Gilead SciencesIndustry Sponsor
1,085 Previous Clinical Trials
846,972 Total Patients Enrolled
7 Trials studying Ulcerative Colitis
2,236 Patients Enrolled for Ulcerative Colitis
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
185,402 Total Patients Enrolled
6 Trials studying Ulcerative Colitis
2,208 Patients Enrolled for Ulcerative Colitis

Media Library

Filgotinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02914535 — Phase 3
Ulcerative Colitis Research Study Groups: Filgotinib 200 mg (blinded dosing), Filgotinib 100 mg (blinded dosing), Placebo (blinded dosing), Filgotinib 200 mg (open-label), Filgotinib 100 mg (open-label)
Ulcerative Colitis Clinical Trial 2023: Filgotinib Highlights & Side Effects. Trial Name: NCT02914535 — Phase 3
Filgotinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02914535 — Phase 3
~268 spots leftby Sep 2026
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