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

Primary Purpose

Fibrostenotic Crohn's Disease

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AGMB-129
Placebo
Sponsored by
Agomab Spain S.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibrostenotic Crohn's Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 up to 2 ileal stricture(s) which should be noncritical naive or anastomotic stricture(s), caused by CD and with at least 1 stricture located in the (neo)terminal ileum within reach of an endoscope 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). Presence of tolerable obstructive symptoms (such as abdominal pain, abdominal pain after eating, limitations in amount or types of food, etc.), and not expected to require hospitalization, endoscopic balloon dilation, surgical resection, or additional therapy during the study. Participants should have sufficient food intake, even with diet modification. Stable background therapy for CD and agree to maintain background therapy for the study duration Exclusion criteria: 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, colonic 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

Sites / Locations

  • Medical Research Center of Connecticut, LLC
  • University of Miami
  • University of MichiganRecruiting
  • Mayo Clinic
  • Washington University School of MedicineRecruiting
  • Cleveland Clinic
  • Medical University of Graz
  • Gemeinnutzige Salzburger Landeskliniken Betriebsgesellschaft mbH (Landeskrankenhaus Salzburg/Regional Hospital Salzburg)
  • Medical University Of Vienna (AKH Wien)
  • University of CalgaryRecruiting
  • Gastroenterology and Internal Medicine Research Institute (GIRI)
  • South Edmonton Gastroenterology Research Clinic
  • TIDHI Innovation Inc.
  • (G.I.R.I) GI Research Institute
  • Bispebjerg Hospital
  • Herlev Hospital (University of Copenhagen)
  • Odense University Hospital
  • Charite Universitatsmedizin Berlin KöR Campus Benjamin Franklin Medizinische
  • Servicegesellschaft Krankenhaus Waldfriede mbH Krankenhaus Waldfriede e.V Akademisches Lehrkrankenhaus der Charite
  • BSF Studiengesellschaft UG (Unternehmergesellschaft, haftungsbeschränkt)
  • Universitatsklinikum Ulm AöR (University of Ulm)
  • Humanitas Research Hospital IRCCS Istituto Clinico Humanitas
  • Azienda Ospedaliero Universitaria di Modena - Struttura Complessa di Gastroenterologia
  • Azienda Ospedaliera San Camillo Forlanini
  • Vita Longa Sp. z.o.o.
  • MEDRISE Sp. z o.o.
  • WIP Warsaw IBD Point Profesor Kierkus
  • Centrum Diagnostyczno-Lecznicze Barska Sp. z o.o.
  • Planetmed Sp. z o.o.
  • Hospital Clinic de Barcelona
  • Hospital Universitario de Gran Canaria Dr. Negrín
  • Hospital Universitario Virgen del Rocio

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

AGMB-129 High

AGMB-129 Low

Placebo

Arm Description

AGMB-129 high dose

AGMB-129 low dose

Matching placebo

Outcomes

Primary Outcome Measures

Number of participants with adverse events
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
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
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
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
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
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

Plasma levels of AGMB-129 and its metabolites
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
To characterize the pharmacodynamics of AGMB-129 by determining the gene expression in ileal biopsies

Full Information

First Posted
April 25, 2023
Last Updated
October 3, 2023
Sponsor
Agomab Spain S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT05843578
Brief Title
STENOVA - A Study to Evaluate Safety, Tolerability, PK and PD of AGMB-129 in Patients With Fibrostenotic Crohn's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Agomab Spain S.L.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this clinical trial is to learn about the safety, pharmacokinetics and pharmacodynamics of AGMB-129 in patients with Crohn's disease. The main questions it aims to answer are: is AGMB-129 safe and well tolerated in these patients? what does the body do to the drug (pharmacokinetics)? what does the drug do to the body (pharmacodynamics)? The participants will be in the study for a total duration of up to 19 weeks, including a 5-week screening period, a 12-week double-blind, placebo-controlled treatment period where they will receive either a high or low dose or placebo (1:1:1), and 2-week safety follow-up period
Detailed Description
This is a randomized, placebo-controlled, double-blind, parallel, multicenter, phase 2a study in participants with fibrostenotic CD. This study 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. Magnetic resonance enterography (MRE) will be performed at screening to assess eligibility. 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, PK, and PD. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibrostenotic Crohn's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized, placebo-controlled, double-blind, parallel, multicenter, phase 2a study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AGMB-129 High
Arm Type
Experimental
Arm Description
AGMB-129 high dose
Arm Title
AGMB-129 Low
Arm Type
Experimental
Arm Description
AGMB-129 low dose
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Matching placebo
Intervention Type
Drug
Intervention Name(s)
AGMB-129
Intervention Description
Oral capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching oral capsule
Primary Outcome Measure Information:
Title
Number of participants with adverse events
Description
To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of adverse events at every visit
Time Frame
From Screening to Week 12
Title
Number of participants with abnormal clinical laboratory values
Description
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
Time Frame
From Screening to Week 12
Title
Number of participants with abnormal ECG parameters
Description
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
Time Frame
From Screening to Week 12
Title
Number of participants with abnormal vital signs
Description
To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of vital signs at every visit
Time Frame
From Screening to Week 12
Title
Number of participants with abnormal physical exams
Description
To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of physical exams at every visit
Time Frame
From Screening to Week 12
Title
Number of participants with abnormal 2D-echocardiography
Description
To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of echocardiography at week 12
Time Frame
From Screening to Week 12
Secondary Outcome Measure Information:
Title
Plasma levels of AGMB-129 and its metabolites
Description
To characterize the pharmacokinetics (PK) of AGMB-129 and its metabolites by measuring the amount in plasma
Time Frame
From Baseline to Week 12
Title
Changes in mRNA gene expression in ileal biopsies
Description
To characterize the pharmacodynamics of AGMB-129 by determining the gene expression in ileal biopsies
Time Frame
From Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 up to 2 ileal stricture(s) which should be noncritical naive or anastomotic stricture(s), caused by CD and with at least 1 stricture located in the (neo)terminal ileum within reach of an endoscope 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). Presence of tolerable obstructive symptoms (such as abdominal pain, abdominal pain after eating, limitations in amount or types of food, etc.), and not expected to require hospitalization, endoscopic balloon dilation, surgical resection, or additional therapy during the study. Participants should have sufficient food intake, even with diet modification. Stable background therapy for CD and agree to maintain background therapy for the study duration Exclusion criteria: 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, colonic 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tim Van Kaem
Phone
+3233023530
Email
clinicalstudies@agomab.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Wiesel, MD
Organizational Affiliation
Agomab Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Medical Research Center of Connecticut, LLC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PACT Gastroenterology Center
Phone
203-281-5161
Email
mrcc@gastrocenter.org
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
305-243-8644
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gastroenterology Clinic | Taubman Center
Phone
888-229-7408
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
507-512-7446
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
IBD Clinical Trials Coordinator
Phone
314-747-4236
Ext
7
Email
ibdstudy@wustl.edu
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
216-444-7000
Facility Name
Medical University of Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Gemeinnutzige Salzburger Landeskliniken Betriebsgesellschaft mbH (Landeskrankenhaus Salzburg/Regional Hospital Salzburg)
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Medical University Of Vienna (AKH Wien)
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
University of Calgary
City
Calgary
ZIP/Postal Code
AB T2N 4Z6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Gastroenterology and Internal Medicine Research Institute (GIRI)
City
Edmonton
ZIP/Postal Code
T5R1W2
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
South Edmonton Gastroenterology Research Clinic
City
Edmonton
ZIP/Postal Code
T6K 4B2
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
TIDHI Innovation Inc.
City
North York
ZIP/Postal Code
ON M6A 3B4
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
(G.I.R.I) GI Research Institute
City
Vancouver
ZIP/Postal Code
BC V6Z 2K5
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Name
Herlev Hospital (University of Copenhagen)
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Name
Charite Universitatsmedizin Berlin KöR Campus Benjamin Franklin Medizinische
City
Berlin
ZIP/Postal Code
12203/12200
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Servicegesellschaft Krankenhaus Waldfriede mbH Krankenhaus Waldfriede e.V Akademisches Lehrkrankenhaus der Charite
City
Berlin
ZIP/Postal Code
14163
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
BSF Studiengesellschaft UG (Unternehmergesellschaft, haftungsbeschränkt)
City
Halle
ZIP/Postal Code
06108
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitatsklinikum Ulm AöR (University of Ulm)
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Humanitas Research Hospital IRCCS Istituto Clinico Humanitas
City
Milan
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Azienda Ospedaliero Universitaria di Modena - Struttura Complessa di Gastroenterologia
City
Modena
ZIP/Postal Code
41124
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Azienda Ospedaliera San Camillo Forlanini
City
Rome
ZIP/Postal Code
00152
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Vita Longa Sp. z.o.o.
City
Katowice
ZIP/Postal Code
40-748
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
MEDRISE Sp. z o.o.
City
Lublin
ZIP/Postal Code
20-582
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
WIP Warsaw IBD Point Profesor Kierkus
City
Warsaw
ZIP/Postal Code
00-728
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Centrum Diagnostyczno-Lecznicze Barska Sp. z o.o.
City
Wloclawek
ZIP/Postal Code
87-800
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Planetmed Sp. z o.o.
City
Wrocław
ZIP/Postal Code
52210
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario de Gran Canaria Dr. Negrín
City
Las Palmas De Gran Canaria
ZIP/Postal Code
35010
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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