Companion diagnostic (CDx) for Ileocolitis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Prometheus Biosciences Selected Center, Warsaw, Poland
Ileocolitis
Companion diagnostic (CDx) - Device
Eligibility
18+
All Sexes
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Study Summary

This study is evaluating whether a drug called PRA023 is safe and effective in people with Crohn's disease.

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Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Companion diagnostic (CDx) will improve 2 primary outcomes, 8 secondary outcomes, and 1 other outcome in patients with Ileocolitis. Measurement will happen over the course of Week 12.

Week 12
Biomarker and clinical improvement
Clinical improvement
Endoscopic Improvement and clinical remission by companion diagnostic (CDx) status
Endoscopic improvement
Induction of clinical remission
Induction of endoscopic and clinical improvement
Normalization of C-reactive protein
Normalization of fecal calprotectin
Safety and tolerability
Simple endoscopy score for Crohn's Disease (SES-CD)
Two component patient-reported outcome (PRO-2) remission

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

PRA023
1 of 1
Experimental Treatment

This trial requires 50 total participants across 1 different treatment group

This trial involves a single treatment. Companion Diagnostic (CDx) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

PRA023Participants to receive PRA023 administered by intravenous (IV) infusion.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 12
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly week 12 for reporting.

Closest Location

Prometheus Biosciences Selected Site - Halifax, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Confirmed diagnosis of Crohn's disease
Moderately to severely active CD as defined by Crohn's disease activity index (CDAI) score and centrally read endoscopy
Must have corticosteroid dependence or have had no response, insufficient response, loss of response and/or intolerance to at least one of the following therapies: corticosteroid, immunosuppressants, or an approved anti-tumor necrosis factor (TNF), anti-integrin, or anti-interleukin (IL)12/23
Able to provide written informed consent and understand and comply with the requirements of the study

Patient Q&A Section

What are the signs of ileocolitis?

"Symptoms of UC are similar to those of CD other than diarrhea, where signs may be absent. The colonoscopic features of ileocolitis are similar to those of UC, though they can be more subtle in the presence of a fistula." - Anonymous Online Contributor

Unverified Answer

What is ileocolitis?

"Chronic, mildly to moderately debilitating colitis is a more common diagnoses in the elderly compared to the younger population. Ileocolitis and UC are both disorders affecting primarily the rectum and both disorders have similar prevalence, duration and treatment. More studies are urgently required to examine the difference in onset age and course of UC and Ileocolitis and their correlation with the development of colitis-associated cancers." - Anonymous Online Contributor

Unverified Answer

Can ileocolitis be cured?

"ileitis is a common form of inflammatory bowel disease. In patients with ileocolitis, a subset has an excellent response to medical therapy but a subset will relapse in the years that follow. A subset of relapsing patients then may have a full remission and the ileocolitis is then said to be cured. However, to achieve the full remission, the patient will have to be treated for a period of time, during which any flare-ups, and relapses, can occur. This is why ileocolitis remains a difficult and dangerous disease to treat." - Anonymous Online Contributor

Unverified Answer

What are common treatments for ileocolitis?

"Patients with colitis and ulcerative colitis frequently receive the common treatments of topical 5-aminosalicylic acid (5ASA), steroids, and antacids. Because the severity and persistence of disease is highly variable, clinicians and patients should consider and incorporate treatment individualization and treatment choice as part of the multidisciplinary treatment plan of patients with colitis." - Anonymous Online Contributor

Unverified Answer

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

"In our study cohort of primary care practice patients with a clinical diagnosis of UC, 3% had signs of ileocolitis according to a single endoscopy, with a moderate to high predictive accuracy. However, 2.5% had unequivocal ileocolitis per the 2-step criteria, reflecting the need for confirmation by the presence of symptoms in one quarter of patients." - Anonymous Online Contributor

Unverified Answer

What causes ileocolitis?

"The exact cause of [ulcerative colitis](https://www.withpower.com/clinical-tri[als](https://www.withpower.com/clinical-trials/als)/ulcerative-colitis) is unknown. It is thought that the process may be affected by various factors including genetics and a microbial cause. It is also thought that there could be infectious and chemical causes, which may have contributed to its higher rates among individuals of Jewish origin (compared to white individuals).\n" - Anonymous Online Contributor

Unverified Answer

What are the common side effects of companion diagnostic (cdx)?

"The main side effects of cdx include gastrointestinal symptoms. Also there are no major life-threatening side effects. However, even though cdx are very helpful in detecting and diagnosing disease conditions, some rare side effects may occur in some patients. The incidence of most side effects is less than 5% while the incidence is up to about 10% for anorexia and diarrhea. Therefore, cdx treatment could be a positive way to cope with the disease and prevent it progressing." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of ileocolitis?

"These data have significant clinical relevance in that the patients who did not respond appropriately in the treatment of ileocolitis would not have benefited from any change in management. We recommend that diagnosis of ulcerative colitis or idiopathic colitis be made as early as possible, thus reducing the length of time for which these patients would need to be treated with corticosteroids before the onset of ileitis can be managed appropriately." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating ileocolitis?

"As a colitis, the treatment of UC often involves antibiotics and immunomodulators. Clinical trials are being performed for the treatment of ileocolitis to examine if these two therapies are helpful in healing the colon and reducing symptoms or even curing the disease. UC and ileocolitis have many similarities. Although ileocolitis does not involve hemorrhaging, it is painful like UC and is characterized by abnormal red and white blood cell count, pain, fever, and diarrhea. Researchers are using pharmacologic therapies and clinical trials to determine if these treatments are actually working and to make improvements." - Anonymous Online Contributor

Unverified Answer

How serious can ileocolitis be?

"Patients with ileocolitis are not commonly hospitalized or have urgent surgical intervention, regardless of the underlying cause. The likelihood of developing symptoms increases with age, but there was no association with the underlying etiology of the ileocolitis. However, patient and physician education regarding ileocolitis, a spectrum of complications, and a delay in the diagnosis of ileocolitis are necessary." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in companion diagnostic (cdx) for therapeutic use?

"Recent findings show significant improvement with the introduction of the new companion diagnostics; the majority of patients were found to be negative for the Fdna of the tested infectious diseases. This method can be further improved by the use of the DNA from the patient's own blood and therefore avoids the invasiveness of the previous technique. The advantages of the new companion diagnostics are in fact multiple, especially given the current lack of reliable diagnostic tools to detect the presence of the parasites in the patient. Thus, there are advantages to the application of the companion diagnostic technique that the traditional diagnostic techniques lack." - Anonymous Online Contributor

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