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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502789-26-01

Acronym

AGMB-129-C102

Enrollment

Registered

2023-10-09

Start date

2023-11-03

Completion date

Unknown

Last updated

2026-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibrostenotic Crohn’s Disease

Brief summary

Adverse events (AEs), Clinical laboratory tests, Electrocardiogram (ECG) findings, Vital signs, Physical examination findings, 2-D echocardiogram findings

Detailed description

PK parameters of AGMB-129 and its metabolites in plasma (Part A and Part B), Change in gene expression at the mRNA level in ileal mucosa (Part A)

Interventions

DRUGPlacebo to IMP AGMB-129

DRUGORG-129

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Adverse events (AEs), Clinical laboratory tests, Electrocardiogram (ECG) findings, Vital signs, Physical examination findings, 2-D echocardiogram findings	—

Secondary

Measure	Time frame
PK parameters of AGMB-129 and its metabolites in plasma (Part A and Part B), Change in gene expression at the mRNA level in ileal mucosa (Part A)	—

Countries

Austria, Denmark, Germany, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026