What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for Ulcerative Colitis include aminosalicylates (e.g., mesalamine), corticosteroids (e.g., prednisone), immunomodulators (e.g., azathioprine), and biologics (e.g., infliximab). Aminosalicylates can cause nausea, headache, and rash. Corticosteroids are associated with weight gain, hypertension, and increased risk of infections. Immunomodulators may lead to bone marrow suppression and liver toxicity. Biologics can cause infusion reactions and increased risk of infections. Janus kinase (JAK) inhibitors, such as Filgotinib, are known to cause side effects including infections, blood clots, and elevated liver enzymes. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

The FDA has approved several treatments for Ulcerative Colitis, including Janus kinase (JAK) inhibitors like tofacitinib (Xeljanz), which was approved for moderate to severe UC. Other related treatments include biologics such as infliximab (Remicade), adalimumab (Humira), and vedolizumab (Entyvio), which target different pathways involved in the inflammatory process of UC. These treatments aim to reduce inflammation and maintain remission in patients with UC.

What other types of research exist?

Promising novel alternatives to Filgotinib for Ulcerative Colitis patients in 2024 include other JAK inhibitors like Tofacitinib and Upadacitinib, as well as biologic agents such as Ustekinumab and Vedolizumab. These alternatives have shown efficacy in clinical trials and offer different mechanisms of action that may benefit patients who do not respond to or cannot tolerate Filgotinib.

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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2018 Phase 3 trial • 449 Patients • NCT02873936

Nasopharyngitis

Upper respiratory tract infection

Headache

Nausea

Bronchitis

Gallbladder empyema

Anaemia

Myocardial ischaemia

Abscess oral

Vulval abscess

Lumbar spinal stenosis

Osteitis

Depression

Rheumatoid arthritis

100%

80%

60%

40%

20%

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

0 / 2Eligibility criteria met

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.