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Biological Therapy

Cell Therapy for Crohn's Disease

Phase 2
Recruiting
Research Sponsored by Avobis Bio, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female, 18-70 years of age
Subjects whose perianal fistula(s) were previously treated with either biologic or conventional therapy whose fistula has demonstrated a failed response or who have documented medication intolerance
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12 to week 104
Awards & highlights

Study Summary

This trial is testing a new treatment for complex Crohn's perianal fistulas. The aim is to compare the new treatment to a standard of care control arm, in terms of safety and efficacy. The trial has 2 parts: Part 1 is for subjects who receive study treatment or standard of care; Part 2 is for subjects who are enrolled in the control arm and may receive the new treatment after week 36.

Who is the study for?
Adults aged 18-70 with Crohn's Disease who have a single perianal fistula that hasn't improved after biologic or conventional therapy, or if they've had an intolerance to these treatments. Women must not be pregnant and agree to use contraception; men with partners of childbearing potential must use barrier contraception.Check my eligibility
What is being tested?
The trial is testing AVB-114 for treating complex Crohn's perianal fistulas compared to standard care. Part 1 involves initial treatment and control groups, while Part 2 allows those in the control group to receive AVB-114 after week 36, following the study protocol.See study design
What are the potential side effects?
Specific side effects are not listed here, but generally, participants may experience risks associated with new medications like allergic reactions, infection risk due to immune system changes, discomfort at injection sites or from procedures involved in the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 70 years old.
Select...
My perianal fistula did not improve with previous treatments or I couldn't tolerate the medication.
Select...
I have a fistula with one internal and one external opening.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12 to week 104
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 to week 104 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in proportions of subjects with combined remission of treated perianal fistula between the AVB-114 and standard of care groups.
Secondary outcome measures
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.
+11 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of Care Treatment + AVB-114Experimental Treatment2 Interventions
Subjects receive the standard of care treatment (seton placement) prior to Day 0, when it is removed and the AVB-114 study treatment is inserted.
Group II: Standard of Care TreatmentActive Control1 Intervention
Subjects receive the standard of care treatment (seton placement) prior to Day 0, when it is removed and then replaced.

Find a Location

Who is running the clinical trial?

Avobis Bio, LLCLead Sponsor
Alimentiv Inc.OTHER
12 Previous Clinical Trials
4,437 Total Patients Enrolled
Joan MorrisStudy DirectorAlimentiv Inc.
2 Previous Clinical Trials
312 Total Patients Enrolled

Media Library

AVB-114 (Biological Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04847739 — Phase 2
Crohn's Disease Research Study Groups: Standard of Care Treatment + AVB-114, Standard of Care Treatment
Crohn's Disease Clinical Trial 2023: AVB-114 Highlights & Side Effects. Trial Name: NCT04847739 — Phase 2
AVB-114 (Biological Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04847739 — Phase 2

Frequently Asked Questions

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

What is the regulatory status of AVB-114?

"At Power, we gave AVB-114 a score of 2 out of 3 in regards to safety. This is because, while there have been Phase 2 trials conducted which only support the medication's safety and not its efficacy."

Answered by AI

What are the requirements for joining this clinical trial?

"This trial is looking for 60 patients with fistulas who meet the following criteria: Male or female, 18-70 years of age, Subjects whose perianal fistula(s) were previously treated with either biologic or conventional therapy whose fistula has demonstrated a failed response or who have documented medication intolerance., Subjects with CD diagnosed at least 6 months prior to screening visit., Subjects with a single fistula tract with one internal opening and one external opening, including a previously performed conversion of a branching Fistula tract to a single fistula tract where the branching occurred outside the sphincter complex."

Answered by AI

Are patients still being sought for this experiment?

"Yes, this is correct. The most recent information from clinicaltrials.gov shows that the trial is still recruiting patients. The listing was created on September 13th 2021 and updated October 3rd, 2022."

Answered by AI

Does the age limit for this trial exclude individuals over 70 years old?

"This trial includes patients aged 18 to 70. However, if you are under 18 or over 65, there are still 80 and 287 studies respectively that might be a better fit."

Answered by AI

How many people have enrolled in this study so far?

"That is correct. The public clinical trials website has the most recent information and it says that this study is open for recruitment. This trial was posted on September 13th, 2021 and edited on October 3rd, 2022. There are 5 locations where this study will take place and a total of 60 patients will be enrolled."

Answered by AI

At how many hospitals is this trial currently taking place?

"This study is currently enrolling patients from 5 sites. The locations are Boston, Rochester, Nashville and 2 other as-of-yet undisclosed cities. To limit travel requirements, it is advised that you select the site nearest to your location."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
What site did they apply to?
Mayo Clinic
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Seeded Cells on Matrix Plug Treating Crohn's Perianal Fistulas (STOMP-II)
2021. "Seeded Cells on Matrix Plug Treating Crohn's Perianal Fistulas (STOMP-II)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04847739.
All > Anal Fistula
~11 spots leftby Dec 2024
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