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AGMB-129 · 4 trials · 2 indications
To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of adverse events at every visit
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
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
To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of vital signs at every visit
To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of physical exams at every visit
To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of echocardiography at week 12
To evaluate the safety and tolerability of AGMB-129 in terms of adverse events (AE) at every visit
To evaluate the safety and tolerability of AGMB-129 in terms of physical examination at every visit
To evaluate the safety and tolerability of AGMB-129 in terms of vital signs
To evaluate the safety and tolerability of AGMB-129 in terms of abnormal electrocardiograms (ECGs) at every visit
To evaluate the safety and tolerability of AGMB-129 in terms of abnormal 2-dimensional (2-D) echocardiography at every visit
To evaluate the safety and tolerability of AGMB-129 in terms of abnormal clinical laboratory parameters at every visit
| Arm | Type | Description |
|---|---|---|
| AGMB-129 High | EXPERIMENTAL | AGMB-129 high dose |
| AGMB-129 Low | EXPERIMENTAL | AGMB-129 low dose |
| Placebo | EXPERIMENTAL | Matching placebo |
| AGMB-129 | EXPERIMENTAL | participants 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 |
| 1 | EXPERIMENTAL | ABC with A=oral capsule under fed conditions B=oral tablet under fasted conditions C=oral tablet under fed conditions |
| 2 | EXPERIMENTAL | CAB with A=oral capsule under fed conditions B=oral tablet under fasted conditions C=oral tablet under fed conditions |
| 3 | EXPERIMENTAL | BCA with A=oral capsule under fed conditions B=oral tablet under fasted conditions C=oral tablet under fed conditions |
| 4 | EXPERIMENTAL | CBA with A=oral capsule under fed conditions B=oral tablet under fasted conditions C=oral tablet under fed conditions |
| 5 | EXPERIMENTAL | BAC with A=oral capsule under fed conditions B=oral tablet under fasted conditions C=oral tablet under fed conditions |
| 6 | EXPERIMENTAL | ACB with A=oral capsule under fed conditions B=oral tablet under fasted conditions C=oral tablet under fed conditions |
| Name | Type | Description |
|---|---|---|
| AGMB-129 | DRUG | Oral capsule |
| Placebo | DRUG | Matching oral capsule |
| MDZ | DRUG | Pre-filled oral syringes |
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...
AGMB-129 is an investigational small molecule being developed for fibrostenotic Crohn's disease, a gastrointestinal condition. It has also been studied in healthy volunteers for pharmacokinetic and drug interaction purposes. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
AGMB-129 is being developed by AgomAb Therapeutics NV, a biopharmaceutical company. The company's ticker symbol is AGMB. AgomAb is conducting clinical trials to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AGMB-129 in patients with fibrostenotic Crohn's disease.
AGMB-129 is in Phase 2 clinical development. The Phase 2 trial, known as STENOVA (NCT05843578), has been completed and evaluated the drug in patients with fibrostenotic Crohn's disease. The drug is investigational and has not been approved by the FDA or other regulatory agencies.
AGMB-129 has been studied in four completed clinical trials. The Phase 2 STENOVA trial (NCT05843578) enrolled 103 patients with fibrostenotic Crohn's disease across multiple countries. Three Phase 1 trials were conducted in healthy volunteers: a drug-drug interaction study with midazolam (NCT05937386), a relative bioavailability and food effect study (NCT06397508), and a multiple ascending dose study (NCT07118878).
No, AGMB-129 is the drug being studied, while STENOVA is the name of the Phase 2 clinical trial evaluating it. The STENOVA trial (NCT05843578) is a study of AGMB-129 in patients with fibrostenotic Crohn's disease. The drug itself is not known by any alternative names.