Filgotinib for Ileocolitis

Toho University Sakura Medical Center, Sakura, Japan
Ileocolitis+1 More
Filgotinib - Drug
All Sexes
Eligible conditions

Study Summary

This study is evaluating whether a drug called filgotinib is safe for people with Crohn's disease.

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Eligible Conditions

  • Ileocolitis
  • Crohn Disease
  • Crohn's Disease (CD)

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Filgotinib will improve 1 primary outcome and 2 secondary outcomes in patients with Ileocolitis. Measurement will happen over the course of Baseline and up to 432 weeks.

Week 432
Change from Baseline in Crohn's Disease Activity Index (CDAI) Scores
Change from Baseline in PRO2 Scores
Week 432
Overall Safety Profile of Filgotinib Evaluated by the Percentage of Participants Experiencing Adverse Events and Abnormal Clinical Laboratory Tests

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

5 Treatment Groups

Placebo (blinded dosing)
Filgotinib 200 mg (open-label)
Placebo group

This trial requires 1000 total participants across 5 different treatment groups

This trial involves 5 different treatments. Filgotinib is the primary treatment being studied. Participants will be divided into 4 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Filgotinib 200 mg (open-label)
Filgotinib 200 mg for up to 432 weeks
Filgotinib 200 mg (blinded dosing)Filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 432 weeks
Filgotinib 100 mg (blinded dosing)Filgotinib 100 mg + placebo to match filgotinib 200 mg for up to 432 weeks
Filgotinib 100 mg (open-label)
Filgotinib 100 mg for up to 432 weeks
Placebo (blinded dosing)
Placebo to match filgotinib 200 mg for up to 432 weeks
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved
Completed Phase 3

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 432 weeks plus 30 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 432 weeks plus 30 days for reporting.

Closest Location

Wisconsin Center for Advanced Research, a division of GI Associates, LLC - Milwaukee, WI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
of cycle before initiating therapy Any female who could get pregnant must have a negative pregnancy test before they start taking this drug. show original
The willingness to refrain from using live or attenuated vaccines during the study and for 12 weeks after the last dose of the study drug. show original
in the study protocol, and agree to continued follow-up show original
Must have completed all required procedures or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study, specifically for patients with Crohn's disease. show original
The person must be able to understand and sign a written informed consent form, which must be obtained before starting any study procedures that are associated with this trial. show original
Must have enrolled in one of the following Gilead-sponsored CD parent protocols: GS-US-419-4015, GS-US-419-4016, or GS-US-419-3895. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of ileocolitis?

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Signs of ileocolitis include diarrhea with blood. Pain in the lower abdomen may indicate colitis involving the ileum and appendix. Fever and tenderness over the site of the lesion may indicate appendicitis.

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How many people get ileocolitis a year in the United States?

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About 914,000 people in the US will suffer from ileocolitis at some point in their lives. There has been steadily declining incidence of UC and IBD across America, with peak incidence peaks occurring at age 50 with a prevalence of 10 to 30 cases per 100,000 population. The American College of Gastroenterology (ACG) recently adopted a formal medical diagnosis of UC. There is now a standard set of questionnaires for clinicians to use in their assessment of possible intestinal disease. These questionnaires can be used to accurately identify a diagnosis of UC. Furthermore, there is an increased reporting by patients of severe flare-ups. There is increasing evidence that people will develop inflammation even without a demonstrable diagnosis.

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Can ileocolitis be cured?

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Data from a recent study demonstrates that patients with ileocolitis have significantly improved symptoms when treated with mesalamine. Data from a recent study of this study suggest that the treatment of IBS can be successful.

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What is ileocolitis?

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Ileopathy should be recognised by the patient and is the most common cause of bowel disorders. Patients can usually recognise symptoms, and the diagnosis is readily made in an exploratory context.

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What are common treatments for ileocolitis?

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Common treatment for IC includes medications and surgery. Other medications used to target symptoms include acetaminophen, laxatives, and other substances to treat diarrhea. Surgery may include either ileostomy or ileoanal anastomosis, and various minimally invasive procedures may be used to control symptoms of IC. Patients are also offered counseling and education.

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What causes ileocolitis?

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All patients with ileocolitis have some form of gastrointestinal involvement. The diagnosis of ileocolitis is most often made when the symptoms of colitis, particularly diarrhea, occur with an associated symptom suggestive of inflammatory bowel disease.

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What is the average age someone gets ileocolitis?

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About half of those patients have the condition at age 50 or older. A recent increase in the average age at ileocolitis diagnosis suggests a declining incidence of the condition which may have important public health implications.

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What are the common side effects of filgotinib?

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Filgotinib is a well-tolerated drug and has a significant role in treating patients with Crohn’s disease and ulcerative colitis. Commonly reported side effects are mostly mild or moderate but may include diarrhea, nausea, vomiting, dyspepsia, constipation, headache, dizziness, and fatigue. Physicians should be aware of these side effects when prescribing filgotinib to patients with any health condition.\n- Filgotinib Prescribing Information, from CIDRAP :

Unverified Answer

What is filgotinib?

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Filgotinib treatment significantly reduces the frequency or duration of pouchitis, ulcers, and fistula in patients with ulcerative colitis who undergo restorative proctocolectomy with ileal pouch-anal anastomosis. Filgotinib-based anti-TNF therapy for ulcerative colitis is highly effective and can result in the long-term remission of patients.

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Does ileocolitis run in families?

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A significant family history of ileocolitis is found in patients with Crohn's disease. The high prevalence of these associations and their significant linkage to IBD8 in our population has not been reported before. Findings from a recent study suggest that the prevalence of familial ileocolitis in the population at large may not be negligible.

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Is filgotinib safe for people?

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Filgotinib was well tolerated in people with UC. The most common adverse events were diarrhea, nausea, and fatigue. Filgotinib has been associated with liver injury in animals. The liver analyte data in this study were consistent with those from previous clinical studies.

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Have there been other clinical trials involving filgotinib?

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There is no clinical trial registered on []. However, the FDA and EMA have approved filgotinib for the treatment of moderate to severe inflammatory bowel disease (IBD). Multiple clinical trials are being studied for indications of IBD that is refractory to current treatments, (IBD-refractory, ulcerative colitis (UC), Crohn's disease, and ulcerative colitis-anal cancer (UC-AC)). The primary endpoint is the efficacy of filgotinib for IBD and UC-AC. Filgotinib is being evaluated for this indication.

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