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AGMB-129

Phase 2

Fibrostenotic Crohn's Disease | Small molecule | Immunology |AgomAb Therapeutics NV|Last Updated: Nov 21, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment133
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05843578STENOVA - A Study to Evaluate Safety, Tolerability, PK and PD of AGMB-129 in Patients With Fibrostenotic Crohn's DiseasePHASE2 ACTIVE NOT_RECRUITING 103 — — Aug 1, 2023Sep 1, 2026Nov 21, 202552 United States, Austria +6
NCT07118878A Multiple Ascending Dose Study With AGMB-129 in Healthy ParticipantsPHASE1 COMPLETED 30 — — Aug 6, 2025Sep 15, 2025Nov 21, 20251 Belgium
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Study Endpoints
Primary Endpoints
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

Number of participant with Adverse Events
From enrollment to the end of treatment at 42 days

To evaluate the safety and tolerability of AGMB-129 in terms of adverse events (AE) at every visit

Number of participant with abnormal Physical examination
From enrollment to the end of treatment at 42 days

To evaluate the safety and tolerability of AGMB-129 in terms of physical examination at every visit

Number of participant with abnormal Vital signs
From enrollment to the end of treatment at 42 days

To evaluate the safety and tolerability of AGMB-129 in terms of vital signs

Number of participant with abnormal electrocardiograms (ECGs) parameters
From enrollment to the end of treatment at 42 days

To evaluate the safety and tolerability of AGMB-129 in terms of abnormal electrocardiograms (ECGs) at every visit

Number of participant with abnormal 2-dimensional (2-D) echocardiography
From enrollment to the end of treatment at 42 days

To evaluate the safety and tolerability of AGMB-129 in terms of abnormal 2-dimensional (2-D) echocardiography at every visit

Number of participant with abnormal clinical laboratory tests
From enrollment to the end of treatment at 42 days

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

Secondary Endpoints
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
Plasma levels of AGMB-129
From enrollment to the end of treatment at 42 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AGMB-129 HighEXPERIMENTALAGMB-129 high dose
AGMB-129 LowEXPERIMENTALAGMB-129 low dose
PlaceboEXPERIMENTALMatching placebo
AGMB-129EXPERIMENTALparticipants will receive a single dose of AGMB-129 (reference cohort) for 7 consecutive days or multiple doses of AGMB-129 (cohort 1, 2, 3) for 7 consecutive days
Interventions
NameTypeDescription
AGMB-129DRUGOral capsule
PlaceboDRUGMatching oral capsule
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites52

Inclusion Criteria (Part A): 1. 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. 2. Presence of at least 1 stricture in the terminal ileum within reach of an endoscope (p...

Countries:United StatesAustriaCanadaDenmarkGermanyItalyPolandSpainBelgium
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Recent Changes (Last 90 Days)
LOWJun 7, 2026NCT05843578primaryCompletionDate: changed
LOWJun 7, 2026NCT05843578primaryCompletionDate: changed
LOWJun 7, 2026NCT05843578primaryCompletionDate: changed
LOWJun 7, 2026NCT05843578primaryCompletionDate: changed
LOWJun 7, 2026NCT05843578primaryCompletionDate: changed
LOWJun 7, 2026NCT05843578primaryCompletionDate: changed
LOWMay 24, 2026NCT05843578studyFirstPostDate: changed