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Janus Kinase (JAK) Inhibitor
Long-Term Filgotinib for Ulcerative Colitis (SELECTIONLTE Trial)
Phase 3
Waitlist Available
Research Sponsored by Alfasigma S.p.A.
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
Must not have
Females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
Summary
This trial aims to observe the safety of filgotinib in adults with ulcerative colitis who were part of an earlier study. Filgotinib reduces inflammation by blocking certain proteins. The goal is to ensure it is safe for extended use.
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.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not willing to follow the study's birth control requirements.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2018 Phase 3 trial • 449 Patients • NCT028739366%
Nasopharyngitis
6%
Upper respiratory tract infection
6%
Headache
5%
Nausea
2%
Bronchitis
1%
Gallbladder empyema
1%
Anaemia
1%
Myocardial ischaemia
1%
Abscess oral
1%
Vulval abscess
1%
Lumbar spinal stenosis
1%
Osteitis
1%
Depression
1%
Rheumatoid arthritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Filgotinib 100 mg
Placebo
Filgotinib 200 mg
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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?
Alfasigma S.p.A.Lead Sponsor
25 Previous Clinical Trials
9,779 Total Patients Enrolled
1 Trials studying Colitis
600 Patients Enrolled for Colitis
Galapagos NVLead Sponsor
139 Previous Clinical Trials
22,319 Total Patients Enrolled
8 Trials studying Colitis
2,193 Patients Enrolled for Colitis
Gilead SciencesIndustry Sponsor
1,129 Previous Clinical Trials
865,934 Total Patients Enrolled
7 Trials studying Colitis
2,236 Patients Enrolled for 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.
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