STENOVA - A Study to Evaluate Safety, Tolerability, PK and PD of AGMB-129 in Patients With Fibrostenotic Crohn's Disease

NCT05843578 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: AGMB-129-C102
• Study Type: interventional
• Target: 103
• Locations: 8 countries
• Sites: 52

Brief 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

Fibrostenotic Crohn's Disease

Outcome Measures

Primary Outcomes (6)

• Number of participants with adverse events (Part A and B)

  To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of adverse events at every visit

  From Screening to Week 48

• Number of participants with abnormal clinical laboratory values (Part A and B)

  To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of abnormal laboratory parameters at every visit

  From Screening to Week 48

• Number of participants with abnormal ECG parameters (Part A and B)

  To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of abnormal ECG parameters at every visit

  From Screening to Week 48

• Number of participants with abnormal vital signs (Part A and B)

  To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of vital signs at every visit

  From Screening to Week 48

• Number of participants with abnormal physical exams (Part A and B)

  To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of physical exams at every visit

  From Screening to Week 48

• Number of participants with abnormal 2D-echocardiography (Part A and B)

  To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of echocardiography at week 12

  From Screening to Week 48

Secondary Outcomes (2)

• Plasma levels of AGMB-129 and its metabolites (Part A and B)

  From Baseline to Week 48

• Changes in mRNA gene expression in ileal biopsies ((Part A)

  From Baseline to Week 48

Study Arms (3)

AGMB-129 High

EXPERIMENTAL

AGMB-129 high dose

Drug: AGMB-129

AGMB-129 Low

EXPERIMENTAL

AGMB-129 low dose

Drug: AGMB-129

Placebo

EXPERIMENTAL

Matching placebo

Drug: Placebo

Interventions

AGMB-129 DRUG

Oral capsule

AGMB-129 High; AGMB-129 Low

Placebo DRUG

Matching oral capsule

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of ileal or ileocolonic CD based on supporting guideline criteria (eg, clinical, endoscopic, and histologic evidence) established at least 3 months prior to screening.
• Presence of at least 1 stricture in the terminal ileum within reach of an endoscope (passable or nonpassable).Strictures should be noncritical, naïve or anastomotic stricture(s), caused by CD and confirmed centrally by MRE according to the following criteria:
• Localized luminal narrowing (luminal diameter ≤50% relative to normal adjacent bowel); AND
• Bowel wall thickening (≥25% relative to adjacent bowel; AND
• Either prestenotic dilation (defined as a luminal diameter ≥3 cm) or nonpassable with adult colonoscope
• Presence of tolerable obstructive symptoms, as defined by a screening S-PRO severity score ≥2, and not expected to require hospitalization, endoscopic balloon dilation, surgical resection, or additional therapy during the study. Participant should have sufficient food intake, even with diet modification.
• Stable background therapy for CD and agree to maintain background therapy for the study duration

You may not qualify if:

• History or current diagnosis of ulcerative colitis, indeterminate colitis, ischemic colitis, nonsteroidal anti-inflammatory drug-induced colitis, idiopathic colitis (ie, colitis not consistent with CD), radiation colitis, microscopic colitis, colonic mucosal dysplasia, or untreated bile acid malabsorption.
• CD-related complications (previous extensive small bowel resection, ileorectal anastomosis, proctocolectomy, short bowel syndrome, ileostomy \[diverting or end\], colostomy, small bowel stoma, ileoanal pouch, inactive fistulae in or adjacent to an ileal stricture, anal and perianal stricture, active intra-abdominal or perianal abscess that has not been appropriately treated, abscess in relation to the stricture, toxic megacolon, very severe inflammation, or presence of deep ulceration in the colon or terminal ileum).
• Ileitis not associated with CD (eg, ileitis associated with infections, spondyloarthropathies, ischemia, etc.).
• Endoscopic balloon dilation or surgical treatment of the same small bowel stricture within the last 6 months prior to screening
• Receiving cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 8 weeks of screening or Janus kinase inhibitor therapy within 4 weeks of screening.
• Requiring continued treatment with systemically administered medications that are sensitive CYP3A4/5 substrates with a narrow therapeutic index or strong inhibitors of aldehyde oxidase or xanthine oxidase.
• Current or history of vasculitis, valvulopathy or large vessel disorder or major abnormalities documented by cardiac echocardiography with Doppler
• Completion of the 12-week treatment period (Part A) and participant is willing and able to continue treatment.
• Per investigator judgment, participant is able to continue or resume treatment following completion of the Week 12 visit in Part A.
• More than 24 weeks since completion of the Week 12 visit in Part A.
• Experienced any AE leading to permanent treatment discontinuation during treatment with study drug in the double blind treatment period (Part A).
• Have undergone endoscopic balloon dilation or bowel surgery (resection surgery or strictureplasty) for any intestinal stricture since the Week 12 visit in Part A.
• Any condition which in the opinion of the investigator affects the safety or ability to participate in Part B.
• Participation in any other clinical trial since the completion of the Week 12 visit in Part A.

Sponsors & Collaborators

• Agomab Spain S.L.U.: lead

Study Sites (52)

Medical Research Center of Connecticut, LLC

Hamden, Connecticut, 06518, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Digestive and Liver Center of Florida

Orlando, Florida, 32825, United States

Location

Gastroenterology Health Partners

New Albany, Indiana, 47150, United States

Location

Gastroenterology Health Partners

Louisville, Kentucky, 40218, United States

Location

Louisiana Research Center

Shreveport, Louisiana, 71105, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Gastro One

Cordova, Tennessee, 38018, United States

Location

Medical University of Graz

Graz, 8036, Austria

Location

Gemeinnutzige Salzburger Landeskliniken Betriebsgesellschaft mbH (Landeskrankenhaus Salzburg/Regional Hospital Salzburg)

Salzburg, 5020, Austria

Location

Medical University Of Vienna (AKH Wien)

Vienna, 1090, Austria

Location

Hospital Landstrasse, Department of Internal Medicine IV

Vienna, Austria

Location

University of Calgary

Calgary, AB T2N 4Z6, Canada

Location

Gastroenterology and Internal Medicine Research Institute (GIRI)

Edmonton, T5R1W2, Canada

Location

South Edmonton Gastroenterology Research Clinic

Edmonton, T6K 4B2, Canada

Location

Nova Scotia Health Authority

Halifax, Canada

Location

TIDHI Innovation Inc.

North York, ON M6A 3B4, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Canada

Location

(G.I.R.I) GI Research Institute

Vancouver, BC V6Z 2K5, Canada

Location

Aarhus University Hospital, Department of Hepatology and Gastroenterology

Aarhus, Denmark

Location

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Rigshospitalet - University Hospital Copenhagen

Copenhagen, Denmark

Location

Herlev Hospital (University of Copenhagen)

Herlev, 2730, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Charite Universitatsmedizin Berlin KöR Campus Benjamin Franklin Medizinische

Berlin, 12203/12200, Germany

Location

Servicegesellschaft Krankenhaus Waldfriede mbH Krankenhaus Waldfriede e.V Akademisches Lehrkrankenhaus der Charite

Berlin, 14163, Germany

Location

BSF Studiengesellschaft UG (Unternehmergesellschaft, haftungsbeschränkt)

Halle, 06108, Germany

Location

Universitatsklinikum Ulm AöR (University of Ulm)

Ulm, 89081, Germany

Location

University Polyclinic Hospital "G. Martino"

Messina, Italy

Location

Humanitas Research Hospital IRCCS Istituto Clinico Humanitas

Milan, 20089, Italy

Location

Hospital San Raffaele

Milan, Italy

Location

Azienda Ospedaliero Universitaria di Modena - Struttura Complessa di Gastroenterologia

Modena, 41124, Italy

Location

Sacred Heart Don Calabria

Negrar, Italy

Location

Azienda Ospedaliera San Camillo Forlanini

Rome, 00152, Italy

Location

University Polyclinic Foundation "Agostino Gemelli"

Rome, Italy

Location

Specialist Gastrology Centre GASTROMED

Bialystok, Poland

Location

Vita Longa Sp. z.o.o.

Katowice, 40-748, Poland

Location

MEDRISE Sp. z o.o.

Lublin, 20-582, Poland

Location

SOLUMED Medical Center

Poznan, Poland

Location

Endoskopia Sp. z o.o.

Sopot, Poland

Location

H-T. Medical Center

Tychy, Poland

Location

WIP Warsaw IBD Point

Warsaw, 00-728, Poland

Location

WSD Medi Clinical Sp. z o.o.

Warsaw, Poland

Location

Planetmed Sp. z o.o.

Wroclaw, 52210, Poland

Location

VISTAMED

Wroclaw, Poland

Location

ETG Zamość

Zamość, 22-400, Poland

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario de Gran Canaria

Las Palmas de Gran Canaria, 35010, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Study Officials

• Philippe Wiesel, MD

  Agomab Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, placebo-controlled, double-blind, parallel, multicenter, phase 2a study

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 6, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7); US (11); AU (4); IT (7); DK (5); PL (11); ES (3); DE (4)