STENOVA - A Study to Evaluate Safety, Tolerability, PK and PD of AGMB-129 in Patients With Fibrostenotic Crohn's Disease
- Conditions
- Fibrostenotic Crohn's Disease
- Interventions
- Drug: Placebo
- Registration Number
- NCT05843578
- Lead Sponsor
- Agomab Spain S.L.
- 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.
- Detailed Description
Part A is a randomized, placebo-controlled, double-blind, parallel, multicenter, phase 2a study in participants with Crohn's disease and symptomatic intestinal strictures.
Part A consists of 3 periods (a screening period, a placebo-controlled, double-blind treatment period, and safety follow-up). After signing informed consent, eligibility will be assessed during a 5-week screening period. The presence of qualifying intestinal strictures will be assessed by ileocolonoscopy and magnetic resonance enterography (MRE). The presence of obstructive symptoms will be also evaluated.
Eligible participants will be randomized 1:1:1 to receive AGMB-129 high dose, low dose or placebo for 12 weeks.
During Screening and Week 12 visits, participants will undergo ileocolonoscopy with biopsy collection for exploring pharmacodynamics. Participants will have blood sample collection at Weeks 2, 4, 8, and 12 to assess safety, pharmacokinetics, and pharmacodynamics.
Throughout the study, participants will undergo routine safety assessments at study visits, which will include physical examination, vital signs, clinical laboratory assessment, electrocardiogram (ECG), and recording of AEs.
Part B is an open-label treatment extension for participants who have completed the double-blind treatment period in Part A.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 103
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AGMB-129 Low AGMB-129 AGMB-129 low dose AGMB-129 High AGMB-129 AGMB-129 high dose Placebo Placebo Matching placebo
- Primary Outcome Measures
Name Time Method Number of participants with adverse events (Part A and B) From Screening to Week 48 To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of adverse events at every visit
Number of participants with abnormal clinical laboratory values (Part A and B) From Screening to Week 48 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
Number of participants with abnormal ECG parameters (Part A and B) From Screening to Week 48 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
Number of participants with abnormal vital signs (Part A and B) From Screening to Week 48 To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of vital signs at every visit
Number of participants with abnormal physical exams (Part A and B) From Screening to Week 48 To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of physical exams at every visit
Number of participants with abnormal 2D-echocardiography (Part A and B) From Screening to Week 48 To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of echocardiography at week 12
- Secondary Outcome Measures
Name Time Method Plasma levels of AGMB-129 and its metabolites (Part A and B) From Baseline to Week 48 To characterize the pharmacokinetics (PK) of AGMB-129 and its metabolites by measuring the amount in plasma
Changes in mRNA gene expression in ileal biopsies ((Part A) From Baseline to Week 48 To characterize the pharmacodynamics of AGMB-129 by determining the gene expression in ileal biopsies
Trial Locations
- Locations (51)
University Polyclinic Foundation "Agostino Gemelli"
🇮🇹Rome, Italy
Specialist Gastrology Centre GASTROMED
🇵🇱Białystok, Poland
Vita Longa Sp. z.o.o.
🇵🇱Katowice, Poland
MEDRISE Sp. z o.o.
🇵🇱Lublin, Poland
SOLUMED Medical Center
🇵🇱Poznań, Poland
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Humanitas Research Hospital IRCCS Istituto Clinico Humanitas
🇮🇹Milan, Italy
Hospital San Raffaele
🇮🇹Milan, Italy
Azienda Ospedaliero Universitaria di Modena - Struttura Complessa di Gastroenterologia
🇮🇹Modena, Italy
Sacred Heart Don Calabria
🇮🇹Negrar, Italy
WSD Medi Clinical Sp. z o.o.
🇵🇱Warsaw, Poland
Azienda Ospedaliera San Camillo Forlanini
🇮🇹Rome, Italy
South Edmonton Gastroenterology Research Clinic
🇨🇦Edmonton, Canada
Nova Scotia Health Authority
🇨🇦Halifax, Canada
TIDHI Innovation Inc.
🇨🇦North York, Canada
Ottawa Hospital Research Institute
🇨🇦Ottawa, Canada
(G.I.R.I) GI Research Institute
🇨🇦Vancouver, Canada
Aarhus University Hospital, Department of Hepatology and Gastroenterology
🇩🇰Aarhus, Denmark
Bispebjerg Hospital
🇩🇰Copenhagen, Denmark
Rigshospitalet - University Hospital Copenhagen
🇩🇰Copenhagen, Denmark
Herlev Hospital (University of Copenhagen)
🇩🇰Herlev, Denmark
Odense University Hospital
🇩🇰Odense, Denmark
Charite Universitatsmedizin Berlin KöR Campus Benjamin Franklin Medizinische
🇩🇪Berlin, Germany
Servicegesellschaft Krankenhaus Waldfriede mbH Krankenhaus Waldfriede e.V Akademisches Lehrkrankenhaus der Charite
🇩🇪Berlin, Germany
BSF Studiengesellschaft UG (Unternehmergesellschaft, haftungsbeschränkt)
🇩🇪Halle, Germany
Universitatsklinikum Ulm AöR (University of Ulm)
🇩🇪Ulm, Germany
University Polyclinic Hospital "G. Martino"
🇮🇹Messina, Italy
Endoskopia Sp. z o.o.
🇵🇱Sopot, Poland
H-T. Medical Center
🇵🇱Tychy, Poland
WIP Warsaw IBD Point
🇵🇱Warsaw, Poland
VISTAMED
🇵🇱Wroclaw, Poland
Planetmed Sp. z o.o.
🇵🇱Wrocław, Poland
ETG Zamość
🇵🇱Zamość, Poland
Medical Research Center of Connecticut, LLC
🇺🇸Hamden, Connecticut, United States
University of Miami
🇺🇸Miami, Florida, United States
Digestive and Liver Center of Florida
🇺🇸Orlando, Florida, United States
Gastroenterology Health Partners
🇺🇸Louisville, Kentucky, United States
Louisiana Research Center
🇺🇸Shreveport, Louisiana, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Gastro One
🇺🇸Cordova, Tennessee, United States
Medical University of Graz
🇦🇹Graz, Austria
Gemeinnutzige Salzburger Landeskliniken Betriebsgesellschaft mbH (Landeskrankenhaus Salzburg/Regional Hospital Salzburg)
🇦🇹Salzburg, Austria
Medical University Of Vienna (AKH Wien)
🇦🇹Vienna, Austria
Hospital Landstrasse, Department of Internal Medicine IV
🇦🇹Vienna, Austria
University of Calgary
🇨🇦Calgary, Canada
Gastroenterology and Internal Medicine Research Institute (GIRI)
🇨🇦Edmonton, Canada
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario de Gran Canaria
🇪🇸Las Palmas De Gran Canaria, Spain