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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: Active Phase 2 study of Fibrostenotic Crohn's Disease, sponsored by Agomab Spain S.L.U..
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of adverse events at every visit
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 |
What the registry record for NCT05843578 still lists
NCT05843578 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower).
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 names 20 study sites across 11 states, led by 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
How this trial's enrollment target compares
Where NCT05843578's enrollment target sits among peer trials
103 664th of 2000 higher than 1,333 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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