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NCT04847739 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Crohn's Disease and Perianal Fistula, sponsored by Avobis Bio.

Active
Registry status
Phase 2
Development phase
60
Enrollment target
15
Study locations

NCT04847739 is a Phase 2 study of Crohn's Disease and Perianal Fistula that is active but no longer recruiting, run by Avobis Bio. The registered enrollment target is 60 participants, below the 2,394-participant average among 105 other Crohn's Disease trials with a reported enrollment target (97% lower). The trial reports 15 study locations across 11 states.

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The verdict

NCT04847739, a Phase 2 study of Crohn's Disease and Perianal Fistula, is active but no longer recruiting, sponsored by Avobis Bio.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
60 participants
Enrollment target
15
Study locations

Study Summary

A Phase II study to assess the safety and efficacy of AVB-114 in treatment of complex Crohn's perianal fistulas in subjects with quiescent rectal disease and whose fistula has failed to respond to biologic or conventional therapy. Combined remission of treated perianal fistula in the investigational treatment arm will be compared to a standard of care control arm. The study has 2 parts: Part 1: All required study visits for subjects who initially receive study treatment and those who receive standard of care therapy (control arm). Part 2: Subjects who are enrolled in the control arm may receive treatment with AVB-114 following week 36. Those subjects then will be followed as specified in the clinical protocol.

Conditions Studied

Crohn's Disease Perianal Fistula

Interventions

  • PROCEDURE Seton Placement
  • DRUG AVB-114

Study Locations (15)

California

  • Office of Phillip Fleshner, MD - Los Angeles
  • Stanford University - Redwood City
  • UC Davis - Sacramento

Florida

  • Mayo Clinic Jacksonville - Jacksonville
  • University of Miami - Miami

New York

  • NYU Langone Health - New York
  • Weill Cornell Medical College - NY Presbyterian Hospital - New York

Arizona

  • Mayo Clinic Arizona - Phoenix

Colorado

  • University of Colorado School of Medicine - Aurora

Illinois

  • UChicago Medicine and Biological Sciences - Chicago

Indiana

  • Indiana University Health University Hospital - Indianapolis

Massachusetts

  • Mass Gen Hospital - Boston

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2021-09-13
Est. Completion 2026-08
Phase Phase 2

Sponsor

Avobis Bio

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04847739

The ClinicalTrials.gov registry entry for NCT04847739 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,394-participant average among 105 other Crohn's Disease trials with a reported enrollment target (97% lower). The listed sponsor is Avobis Bio, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Crohn's Disease appearing as the primary indexed condition, and to 2 interventions - of which Seton Placement is the first listed.

NCT04847739 reports 15 study locations spanning 11 distinct geographic areas - top geographies include California, Florida, New York.

Frequently Asked Questions

What is clinical trial NCT04847739 about?

NCT04847739 is a clinical study titled "Seeded Cells on Matrix Plug Treating Crohn's Perianal Fistulas (STOMP-II)". A Phase II study to assess the safety and efficacy of AVB-114 in treatment of complex Crohn's perianal fistulas in subjects with quiescent rectal disease and whose fistula has failed to respond to biologic or conventional therapy. Combined remission of treated perianal fistula in the investigational...

What is the current status of trial NCT04847739?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2021-09-13. Estimated completion is 2026-08.

What conditions does trial NCT04847739 study?

This clinical trial studies the following conditions: Crohn's Disease, Perianal Fistula.

What interventions are being tested in trial NCT04847739?

The interventions under investigation include: Seton Placement (PROCEDURE), AVB-114 (DRUG).

Who is sponsoring clinical trial NCT04847739?

This trial is sponsored by Avobis Bio, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04847739 being conducted?

This trial has 15 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.