Filgotinib for Ileocolitis

Phase-Based Estimates
2
Effectiveness
3
Safety
Hospital de Braga, Braga, Portugal
Ileocolitis+1 More
Filgotinib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Ileocolitis

Study Summary

Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease

See full description

Eligible Conditions

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

Treatment Effectiveness

Effectiveness Estimate

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

Compared to trials

Study Objectives

This trial is evaluating whether Filgotinib will improve 4 primary outcomes and 10 secondary outcomes in patients with Ileocolitis. Measurement will happen over the course of Week 10.

Week 10
Induction Study: Proportion of Participants Achieving Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10
Induction Study: Proportion of Participants Achieving Clinical Remission by Patient Reported Outcomes (PRO2) at Week 10
Induction Study: Proportion of Participants Achieving Clinical Response by CDAI at Week 10
Induction Study: Proportion of Participants Achieving Endoscopic Response at Week 10
Week 58
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib and its Metabolite GS-829845
Week 10
Induction Study: Pharmacokinetic Concentrations of Filgotinib and its Metabolite GS-829845
Week 58
Maintenance Study: Proportion of Participants Achieving 6 Month Corticosteroid-Free Remission by CDAI at Week 58
Maintenance Study: Proportion of Participants Achieving 6 Month Corticosteroid-Free Remission by PRO2 at Week 58
Maintenance Study: Proportion of Participants Achieving Clinical Remission by CDAI at Week 58
Maintenance Study: Proportion of Participants Achieving Clinical Remission by PRO2 at Week 58
Maintenance Study: Proportion of Participants Achieving Clinical Response by CDAI at Week 58
Maintenance Study: Proportion of Participants Achieving Endoscopic Response at Week 58
Maintenance Study: Proportion of Participants Achieving Sustained Clinical Remission by CDAI
Maintenance Study: Proportion of Participants Achieving Sustained Clinical Remission by PRO2

Trial Safety

Safety Estimate

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

Compared to trials

Trial Design

4 Treatment Groups

Placebo (Induction Study)
Filgotinib 100 mg (Induction Study)
Placebo group

This trial requires 1374 total participants across 4 different treatment groups

This trial involves 4 different treatments. Filgotinib is the primary treatment being studied. Participants will be divided into 3 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 100 mg (Induction Study)Filgotinib 100 mg + placebo to match filgotinib 200 mg for 10 weeks
Maintenance StudyParticipants who meet response or remission criteria at Week 10 will continue into the Maintenance Study and receive filgotinib and/or placebo for 48 weeks.
Filgotinib 200 mg (Induction Study)Filgotinib 200 mg + placebo to match filgotinib 100 mg for 10 weeks
Placebo (Induction Study)
Drug
Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg for 10 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo to match filgotinib
2016
Completed Phase 3
~3600
Filgotinib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 26 (predose or postdose) and week 58 predose
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly week 26 (predose or postdose) and week 58 predose for reporting.

Closest Location

Gastro One - Germantown, TN

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:
Key
The people in cohort B have shown an inadequate response to, loss of response to, or intolerance to at least one of the following types of treatment: TNFa antagonists, vedolizumab, and ustekinumab. show original
The person has CD and it has been documented by a doctor that they have had it for at least three months and it has affected their ileum and/or colon show original
(10 mg/day or greater of prednisone or equivalent for ≥1 month or methotrexate, azathioprine, mycophenolate mofetil, or 6-mercaptopurine for ≥6 months); TNF inhibitors (adalimumab, certolizumab pegol, etanercept, golimumab, Infliximab) Patients in Cohort A have failed treatment with at least one of the following: corticosteroids and immunomodulators (10 mg/day or greater of prednisone or equivalent for ≥1 month or methotrexate, azathioprine, mycophenolate mofetil, or 6-mercaptopurine for ≥6 months); TNF inhibitors (adalimumab, certolizumab pegol, etanercept, golimumab, Infliximab). show original
Cohort A is composed of patients who have not responded to or tolerated at least one of the following medications: tumor necrosis factor alpha inhibitors, vedolizumab, and ustekinumab show original
were eligible People 18 to 75 years old who are not pregnant or breastfeeding can participate in this study. show original
Moderately to severely active CD

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 common side effects of filgotinib?

Add answer

Overall, filgotinib was well-tolerated in our study. The common side effects of the medication included nausea, fatigue, constipation, headaches and diarrhea. Filgotinib was not associated with an increased risk of developing cancers or serious infections. These side effects were similar to those reported in previous clinical trials.

Unverified Answer

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

Add answer

Although the diagnosis is often made based on clinical presentation, many patients with IBD have an underlying subclinical inflammation that doesn't completely resolve when in remission. Therefore, patients with IBD are not aware of their disease's real extent, which could potentially affect them as their illness progresses. Therefore, IELIS-PODIS (Ileocolitis Assessment and Management Using a Simple Patient Questionnaire) can be used to measure disease progression in IBD and can be used to evaluate new treatments for the disease and to monitor relapse risk in patients with IBD. Furthermore, if the disease severity progresses in patients with IBD, this can affect their ability to manage their pain and manage their side effects from medications.

Unverified Answer

What causes ileocolitis?

Add answer

The ileocolitis in inflammatory bowel disease and other diseases is a clinical syndrome. It is not a specific disease entity and the pathogenesis of it is not a uniform entity. For instance, colonic biopsy from patients with ileocolitis may show inflammation without the characteristic epithelial changes of inflammatory bowel diseases of the colon and pouch. In many patients, ileocolitis may be the earliest sign of inflammatory bowel disease. In this context it is important to specify the specific diagnosis of the disease, and for this reason guidelines were published in 2002 and 2010. However, these criteria and guidelines have been criticized owing to inadequate clinical research.

Unverified Answer

What are common treatments for ileocolitis?

Add answer

The optimal treatment for patients with ulcerative colitis is not completely established. However, many patients may be managed on a maintenance treatment regimen with medications including NSAID, corticosteroids, and 5-ASA's. This allows the use of a more effective therapy by titrating at a manageable low dose and prevents disease flares at the same time. The management of patients with Crohn's disease is still controversial and is currently investigated. Patients with more severe disease may receive surgery and/or bioprosthetic therapy for more serious disease flares.

Unverified Answer

Can ileocolitis be cured?

Add answer

Ileocolitis in Crohn's disease and ulcerative colitis is primarily a disease of the mucosa, and can only be cured by the removal of the mucosal lesions as a whole.

Unverified Answer

What are the signs of ileocolitis?

Add answer

Symptoms which may be features of [ulcerative colitis](https://www.withpower.com/clinical-trials/ulcerative-colitis) include weight loss, bloody stools, tiredness, diarrhea, loss of appetite and abdominal pain. Symptoms which can also be present when ileocolitis is part of ulcerative colitis such as weight loss, bloody stools, tiredness, diarrhea, diarrhea-predominant right-sided colitis and the presence of erythema nodosum may all be signs of ulcerative colitis rather than ileocolitis. While some patients may have a mixed diagnosis of ileocolitis and ulcerative colitis, either presentation can be enough to diagnose a colonic Crohn's disease.

Unverified Answer

What is ileocolitis?

Add answer

In a recent study, findings demonstrates that ileocolitis is an autoimmune condition associated with elevated levels of TNF-alpha and IL-6, whereas TGF-beta is probably of normal low level. Measurement of IL-6 and TNF-alpha in intestinal tissue may be useful in differentiating the cause of inflammatory colitis.

Unverified Answer

What is the average age someone gets ileocolitis?

Add answer

iliacocolitis, although uncommon, affects patients of all ages. Approximately 3 out of 10 of these patients were women over the age of 60, and half were black. iliacocolitis had a similar incidence for colon, ileo, and ceco-pelvic colitis within the same patient. It was an important differential diagnosis from colonic Crohn's disease and colitis, the two other most common types of ileitis. Further investigation is required to establish the prevalence and mechanisms of iliacocolitis.

Unverified Answer

What does filgotinib usually treat?

Add answer

In this pooled analysis filgotinib was found to significantly reduce the relapse rates for both pouch surgery and adhesion surgery for all patients treated. A subset of patients with a high-risk profile in terms of IPAA-related co-morbidities demonstrated significantly improved outcomes upon treatment with filgotinib. This pooled analysis showed that filgotinib did not seem to negatively influence the intestinal healing as reported for other small bowel cancer indications.

Unverified Answer

How serious can ileocolitis be?

Add answer

Ileocolitis affects 2.8-8 (6–14%) of people in hospitals. Complications can occur, such as abscess formation, perforation, leakage of fluid from the ulceration, sepsis, septic arthritis, bowel obstruction and/or the release of toxic substances from the ulceration, and abscess formation. The prognosis is dependent on what stage of ulceration is discovered. Most cases are asymptomatic, but in the advanced stage of surgery, most patients are hospitalized, and prognosis deteriorates. Prognosis of the disease is poor.

Unverified Answer

What is filgotinib?

Add answer

(a) There is potential for the use of the medication to treat Crohn's disease and its use in this way merits further investigation. (b) The drug is a first-in-class kinase inhibitor for the treatment of gastrointestinal tumors. The drug is also being investigated in the treatment of other gastrointestinal diseases, such as pancreatitis, ulcerative colitis, and colorectal cancer. (c) The drug seems effective but has a number of undesirable side effects, including hypertension, fatigue, and nausea.

Unverified Answer

Have there been any new discoveries for treating ileocolitis?

Add answer

The therapies for ileocolitis are more developed than those for colitis due to its long duration. New research will continue to clarify what treatments can manage the symptoms effectively long term. The treatment for ileocolitis is still challenging and patients will require continued follow-up to assess their symptoms and the best treatment for their condition.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Ileocolitis by sharing your contact details with the study coordinator.