Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05843578 · ClinicalTrials.gov registry record · Phase 2
STENOVA - A Study to Evaluate Safety, Tolerability, PK and PD of AGMB-129 in Patients With Fibrostenotic Crohn's Disease
A Phase 2 study of Fibrostenotic Crohn's Disease, sponsored by Agomab Spain S.L.U..
- Active
- Registry status
- Phase 2
- Development phase
- 103
- Enrollment target
- 20
- Study locations
NCT05843578 is a Phase 2 study of Fibrostenotic Crohn's Disease that is active but no longer recruiting, run by Agomab Spain S.L.U.. The registered enrollment target is 103 participants. The trial reports 20 study locations across 11 states.
The verdict
NCT05843578, a Phase 2 study of Fibrostenotic Crohn's Disease, is active but no longer recruiting, sponsored by Agomab Spain S.L.U..
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 103 participants
- Enrollment target
- 20
- Study locations
Study Summary
Many patients with Crohn's disease develop fibrotic narrowing (strictures) in their bowel, causing obstructive symptoms such as abdominal pain, cramping, or vomiting after meals. Because of these symptoms, patients often require bowel resection surgery. The objective of this clinical trial is to evaluate the safety, pharmacokinetics, and pharmacodynamics of AGMB-129 in patients with Crohn's disease and symptomatic strictures, and whether it can have a beneficial effect on intestinal strictures. The participants will be in the Part A for a duration of up to 19 weeks including a 5 week screening period, a 12-week double-blind, placebo-controlled treatment period, and 2 week safety follow up period. Participants who continue to Part B can receive treatment for up to an additional 48 weeks, with a safety follow-up visit 2 weeks after the last dose of treatment.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG AGMB-129
Study Locations (20)
Other
- Medical University of Graz - Graz
- Gemeinnutzige Salzburger Landeskliniken Betriebsgesellschaft mbH (Landeskrankenhaus Salzburg/Regional Hospital Salzburg) - Salzburg
- Medical University Of Vienna (AKH Wien) - Vienna
- Hospital Landstrasse, Department of Internal Medicine IV - Vienna
- University of Calgary - Calgary
- Gastroenterology and Internal Medicine Research Institute (GIRI) - Edmonton
- South Edmonton Gastroenterology Research Clinic - Edmonton
- Nova Scotia Health Authority - Halifax
- TIDHI Innovation Inc. - North York
Florida
- University of Miami - Miami
- Digestive and Liver Center of Florida - Orlando
Connecticut
- Medical Research Center of Connecticut, LLC - Hamden
Indiana
- Gastroenterology Health Partners - New Albany
Kentucky
- Gastroenterology Health Partners - Louisville
Louisiana
- Louisiana Research Center - Shreveport
Michigan
- University of Michigan - Ann Arbor
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2023-08-01 |
| Est. Completion | 2026-09 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05843578
The ClinicalTrials.gov registry entry for NCT05843578 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Agomab Spain S.L.U., which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Fibrostenotic Crohn's Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05843578 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, Florida, Connecticut.
Frequently Asked Questions
What is clinical trial NCT05843578 about?
NCT05843578 is a clinical study titled "STENOVA - A Study to Evaluate Safety, Tolerability, PK and PD of AGMB-129 in Patients With Fibrostenotic Crohn's Disease". Many patients with Crohn's disease develop fibrotic narrowing (strictures) in their bowel, causing obstructive symptoms such as abdominal pain, cramping, or vomiting after meals. Because of these symptoms, patients often require bowel resection surgery. The objective of this clinical trial is to eva...
What is the current status of trial NCT05843578?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 103 participants. The study started on 2023-08-01. Estimated completion is 2026-09.
What conditions does trial NCT05843578 study?
This clinical trial studies the following conditions: Fibrostenotic Crohn's Disease.
What interventions are being tested in trial NCT05843578?
The interventions under investigation include: Placebo (DRUG), AGMB-129 (DRUG).
Who is sponsoring clinical trial NCT05843578?
This trial is sponsored by Agomab Spain S.L.U., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05843578 being conducted?
This trial has 20 study locations across Connecticut, Florida, Indiana, Kentucky, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Read our methodology - how this data is sourced, computed, and verified.
Related
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.