AVB-114 for Fistula

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Mayo Clinic, Rochester, MN
Fistula+4 More
AVB-114 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

Seeded Cells on Matrix Plug Treating Crohn's Perianal Fistulas (STOMP-II)

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Eligible Conditions

  • Fistula
  • Crohn's Disease (CD)
  • Peri-anal Fistulas

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Fistula

Study Objectives

This trial is evaluating whether AVB-114 will improve 1 primary outcome and 14 secondary outcomes in patients with Fistula. Measurement will happen over the course of Baseline, Week 36.

36 weeks
Change in proportions of subjects with combined remission of treated perianal fistula between the AVB-114 and standard of care groups.
Week 36
Change in patient assessment of impact to daily functionality related to treated fistula between the AVB-114 and standard of care groups.
Week 52
Change in proportions of radiologic response of treated fistula between the AVB-114 and standard of care groups.
Baseline, Week 36
Change in means of disease activity index scores using the Perianal Disease Activity Index (PDAI) between the AVB-114 and standard of care groups.
Change in means of disease activity index scores using the short Crohn's Disease Activity Index (sCDAI) between the AVB-114 and standard of care groups.
Change in means of patient quality of life assessment scores using the Euroqol 5 Diumention 5, level measure of health status (Eq-5Q-5L) between the AVB-114 and standard of care groups.
Change in means of patient quality of life assessment scores using the Inflammatory Bowel Disease Questionnaire (IBDQ) between the AVB-114 and standard of care groups.
Week 104
Change in number of adverse events between the AVB-114 and standard of care groups.
Change in number of serious adverse events between the AVB-114 and standard of care groups.
Week 104
Change in means of time to clinical remission between the AVB-114 and standard of care groups.
Change in means of time to fistula relapse between the AVB-114 and standard of care groups.
Change in proportions of subjects with fistula clinical remission between the AVB-114 and standard of care groups.
Change in proportions of subjects with fistula relapse between the AVB-114 and standard of care groups.
Change in the means of durability of clinical remission between the AVB-114 and standard of care groups.
Week 36
Change in the evaluations of patient care trajectory related to treated fistula between the AVB-114 and standard of care groups.

Trial Safety

Safety Progress

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

Other trials for Fistula

Trial Design

2 Treatment Groups

Standard of Care Treatment
1 of 2
Standard of Care Treatment + AVB-114
1 of 2
Active Control
Experimental Treatment

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. AVB-114 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.

Standard of Care Treatment + AVB-114Subjects receive the standard of care treatment (seton placement) prior to Day 0, when it is removed and the AVB-114 study treatment is inserted.
Standard of Care Treatment
Procedure
Subjects receive the standard of care treatment (seton placement) prior to Day 0, when it is removed and then replaced.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 12 to week 104
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly week 12 to week 104 for reporting.

Closest Location

Mayo Clinic - Rochester, MN

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:
The subject is able and willing to comply with the study protocol and study requirements for the duration of the study. show original
, who are comfortable with traveling independently Male or female, 18-70 years old, who are comfortable traveling independently. show original
People who have had biologic or conventional treatment for perianal fistula that did not work or who had intolerable side effects. show original
People who have been diagnosed with CD at least 6 months before the screening visit. show original
People with a single fistula tract that has one internal and one external opening, including people who have had a conversion of a branching fistula tract to a single fistula tract where the branching occurred outside the sphincter complex. show original
The text states that the ICF must be signed and dated. show original
Women who could potentially become pregnant must have negative blood tests for pregnancy at screening, and must agree to use an effective form of contraception for the entire study show original

Patient Q&A Section

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

"The American Institute of Medicine and the American College of Surgeons estimated that an average of 644,000 patients had ileocolitis in 2001; 676,990 patients in 2002; 691,250 patients in 2003. The number of patients with ileocolitis in this country will continue to increase." - Anonymous Online Contributor

Unverified Answer

What are the signs of ileocolitis?

"Symptoms of ileocolitis can be present throughout the course of the disease. While ileocolitis is thought to be primarily a ntended outcome of disease, the cause is poorly understood." - Anonymous Online Contributor

Unverified Answer

What is ileocolitis?

"Ileocolitis is a severe, chronic condition associated with inflammation of the lower gastrointestinal tract. It is caused by a defect of the immune system that allows bacteria and other microorganisms to invade the small bowel and the colon.\nTreatments of ileocolitis include anti-inflammatory medications such as steroids, antibiotics and oral laxatives"

"Radiophaga\n\nRadiophaga is a recently (2004) described monotypic genus of parasitic isopods in the family Sphaerothromidiidae." - Anonymous Online Contributor

Unverified Answer

What causes ileocolitis?

"Ileal ulcer disease is most commonly caused by a pathogenic process involving alterations of the mucosal barrier function and mucosal immune/non-immune interactions that are intimately associated with ulcerogenic conditions. The diagnosis of ileocolitis should be considered in patients with ileal symptoms that do not respond to a standard regimen of therapy." - Anonymous Online Contributor

Unverified Answer

What are common treatments for ileocolitis?

"Ileal pouching is a surgical procedure involving creation of an ileoanal pouch from ileostomy. Ileostomy can be reversed surgically, but the resultant ileoesophageal diversion is a short term means to a longer problem. Ileostomy should be preferred, the longer situation should be tackled with CBT only, with more and more patients adopting this as their primary treatment for diarrhea. It is not entirely convincing, however, the effect of long term consequences of surgery of ileostomy on patients' life and longevity." - Anonymous Online Contributor

Unverified Answer

Can ileocolitis be cured?

"This retrospective study does not show that the course of ileocolitis can be improved. Only an interdisciplinary team of multiple specialists with extensive experience can effectively manage the disease." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving avb-114?

"Several clinical trials have shown clinical efficacy in treating ulcerative colitis; however, avb-114 has no prior published clinical data. Avb-114 has demonstrated clinical efficacy in mice with experimental ulcerative colitis." - Anonymous Online Contributor

Unverified Answer

What does avb-114 usually treat?

"Avb-114 inhibits expression of CD2 and CD25 on T cells and prevents development of colitis by preventing the proliferation of lymphocytes and increasing apoptosis in T cells. Since the onset of colitis and other autoimmune diseases is thought to be associated with T cell dysregulation, Avb-114 may be effective in treating colitis by inhibiting T cell proliferations." - Anonymous Online Contributor

Unverified Answer

How serious can ileocolitis be?

"Recent findings suggest that the severity of ileocolitis can be a potentially treatable condition. It is recommended that clinical assessment including colonoscopy and ileocolonoscopy precede the initiation of medical treatment for severe cases of ileocolitis. We recommend the use of the Hirsch score for the evaluation of ileocolitis severity." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in avb-114 for therapeutic use?

"The recent advancement in the use of avb-114 in human trials is the fact that a majority of patients reported improvement on their symptoms after initiation of avb-114 and that clinical remission was achieved in a majority of the patients. This is an important advancement relative to previous studies where a minority of patients received an improvement from avb-114. This paper discusses the clinical indications, methods of administration, efficacy and safety of avb-114 in pediatric idiopathic intestinal diseases." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of avb-114?

"Avb-114 is an orally active peptide with potent anti-inflammatory activity, specifically targeting IBD. The most common AEs of avb-114 reported in the phase 2 study to date include headache, dizziness and GI discomfort. More importantly, avb-114 in the treatment of inflammatory bowel disease (IBD) is also efficacious and well tolerated, offering a substantial advantage over existing treatment options." - Anonymous Online Contributor

Unverified Answer

Is avb-114 typically used in combination with any other treatments?

"In the current study, ABB-114 was usually used in combination with any other treatments in inflammatory bowel disease patients, with clinical trials usually focusing on anti-TNFα therapy: this suggests that the therapeutic potential of ABB-114 may be limited." - 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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