STENOVA - A Study to Evaluate Safety, Tolerability, PK and PD of AGMB-129 in Patients With Fibrostenotic Crohn's Disease
Public ClinicalTrials.gov record NCT05843578. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2a, Randomized, Placebo-controlled, Double-blind Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of AGMB-129 in Patients With Fibrostenotic Crohn's Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 (Ontunisertib) 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.
Study identification
- NCT ID
- NCT05843578
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 103 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2023
- Primary completion
- Jun 19, 2026
- Completion
- Jun 19, 2026
- Last update posted
- Jul 8, 2026
2023 – 2026
United States locations
- U.S. sites
- 11
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Medical Research Center of Connecticut, LLC | Hamden | Connecticut | 06518 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Digestive and Liver Center of Florida | Orlando | Florida | 32825 | — |
| Gastroenterology Health Partners | New Albany | Indiana | 47150 | — |
| Gastroenterology Health Partners | Louisville | Kentucky | 40218 | — |
| Louisiana Research Center | Shreveport | Louisiana | 71105 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Gastro One | Cordova | Tennessee | 38018 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 41 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05843578, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 8, 2026 · Synced Sep 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05843578 live on ClinicalTrials.gov.